Feasibility and Acceptability of a Text Message–Based Intervention to Reduce Overuse of Alcohol in Emergency Department Patients: Controlled Proof-of-Concept Trial

Background Emergency department (ED) patients have high rates of risky alcohol use, and an ED visit offers an opportunity to intervene. ED-based screening, brief intervention, and referral to treatment (SBIRT) reduces alcohol use and health care costs. Mobile health (mHealth) interventions may expand the impact of SBIRTs but are understudied in low-resource ED populations. Objective The objective of this study was to assess the feasibility of and patient satisfaction with a text-based mHealth extension of an ED screening program to reduce risky alcohol use in low-income, urban patients. Methods Research assistants screened a convenience sample of ED patients in person for risky alcohol use via the Alcohol Use Disorders Identification Test (AUDIT). Patients who reported AUDIT scores ≥8 and <20 were informed of their AUDIT score and risk. RAs invited patients with SMS text message–capable phones to receive mROAD (mobilizing to Reduce Overuse of Alcohol in the ED), an SMS text message–based extension of the ED screening program. mROAD is a 7-day program of twice-daily SMS text messages based on the National Institutes of Health’s Rethinking Drinking campaign. Participants were allocated to a control group (daily sham text messages without specific guidance on behaviors, such as “Thanks for taking part!”) or to the mROAD intervention group. Patients were interviewed at 30 days to assess acceptability, satisfaction, and changes in drinking behavior. Satisfaction was examined descriptively. Pre and post measurements of drinking behaviors and motivation were compared, as were differences in change scores between the intervention arms. Results Of 1028 patients screened, 95 (9.2%) exhibited risky alcohol use based on AUDIT, and 23/95 (24%) of those patients did not own an SMS text messaging–capable phone; this left 72/95 (76%) eligible patients. Among eligible participants, 48/72 (67%) agreed to enroll; 31/48 (65%) achieved follow-up (18/24 (75%) in the intervention group and 13/24 (55%) in the control group). Participants who completed follow-up reported high satisfaction. Changes in behavior were similar between the arms. Overall, the number of drinking days reported in the prior 30 days decreased by 5.0 (95% CI 1.7-8.3; P=.004), and the number of heavy drinking days decreased by 4.1 (95% CI 1.0 to 7.15, P=.01). Patients reported an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) in motivation to change alcohol use via the Change Questionnaire. The were no statistical differences in drinking days, heavy drinking days, or motivation to change between the arms. Conclusions The mROAD trial was feasible. Over three-quarters of ED patients with risky alcohol use owned a text message–capable phone, and two-thirds of these patients were willing to participate; only 1 patient opted out of the intervention. Although 35% of patients were lost to follow-up at 30 days, those patients who did follow up had favorable impressions of the program; more than 90% reported that SMS text messages were a “good way to teach,” and 89% of intervention arm participants enjoyed the program and found that the messages were motivating. Both the mROAD and sham message groups showed promising changes in alcohol use and motivation to change. mROAD is a feasible intervention that may reduce rates of risky alcohol use in ED patients. Trial Registration ClinicalTrials.gov NCT02158949; https://clinicaltrials.gov/ct2/show/NCT02158949

Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if orine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes 1a-ii) Non-web-based components or impo"ant co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. orine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional orine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

INTRODUCTION 2a) In INTRODUCTION: Scienti!c background and explanation of rationale
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "To understand the feasibility of an mHealth extension of an SBIRT in a low-income, predominantly non-English-speaking population, we conducted a proof-of-concept trial in the ED of an urban, academic safety net hospital. Patients received screening and notiPcation of risk in the ED and were allocated to either an intervention group, which received twice daily theory-driven SMS text messages, or an active control group, which received daily nonspeciPc text messages for seven days. We collected feasibility data, perceptions of acceptability, and preliminary evcacy data 30 days after the intervention ended. " METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Impo"ant changes to methods a#er trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

Yes
Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study not modiPed subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for pa"icipants 3b-i) Bug %xes, Downtimes, Content Changes Bug Pxes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug Pxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have insuenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Adult ED patients were approached in person for initial screening unless precluded by a clinical condition, language barrier (any language other than English or Spanish), or other inability to verbally consent to screening. Patients were screened using a tablet-based survey unless they preferred to have the survey read aloud to them by the research assistant.

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariPed.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. orine), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conPrmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
4b) Se$ings and locations where the data were collected Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

Yes
Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Trained research assistants reviewed the ED electronic tracking board in real time between 7 AM and 11 PM over the course of 3 months (May through July 2014). Adult ED patients were approached in person for initial screening unless precluded by a clinical condition, language barrier (any language other than English or Spanish), or other inability to verbally consent to screening. Patients were screened using a tablet-based survey unless they preferred to have the survey read aloud to them by the research assistant. At recruitment, RAs informed the patient that they were at risk for hazardous alcohol use and invited them to receive SMS text messages upon enrolling. Patients were offered an incentive of a $10 gift card if they choose to enroll to offset the cost of receiving the SMS text messages. Patients were given both a verbal explanation of the project and a copy of the informed consent form. After agreeing to participate, participants were sequentially assigned to either the active control group or the intervention group. Next, patients were registered in the mHealth platform, which sent automated, unidirectional, broadcast SMS text messages for 1 week. Patients selected their preferred language for text messages as English or Spanish. Patients were not required to text a response to be enrolled.

Measures
On enrollment, patients reported their alcohol use by responding to two questions. The Prst question was a general alcohol use question: "Please think back over the last month. How many days did you drink?" The second question was a gender-based assessment of heavy drinking: "Over the last month, how many days did you drink heavily?" ("Heavy drinking" was dePned for women as more than 3 drinks in one day and for men as more than 4 drinks in one day.) Patients were dePned as everyday drinkers or binge drinkers based on their responses to the initial AUDIT screen. Additionally, participants reported their desire to change via the Change Questionnaire applied to risky alcohol use [35][36][37]. The Change Questionnaire consists of 12 statements on a patient's belief of the importance of change, commitment to change, and ability to change; its Cronbach α=.86 when applied to alcohol use [38]. AUDIT scores and mobile phone ownership data were taken from the screening data. " subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4b-i) Repo" if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Patients were contacted 30 days after the intervention to complete a telephone follow-up assessment. Research assistants were blinded to the treatment group at time of follow-up. Patients reported their days of drinking alcohol over the past month, days of heavy drinking over the past month, and desire to change their alcohol-drinking behavior by responding to the same questions asked at enrollment but without visual prompts. Patients in each group also completed a brief acceptability questionnaire. At the end of the trial, we collected the service records of the mobile health platform to ensure that the messages were delivered to each participant as scheduled."

4b-ii) Repo" how institutional a!liations are displayed
Report how institutional avliations are displayed to potential participants [on ehealth media], as avliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 5) The interventions for each group with su%cient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study recruitment was in person at one ED

5-i) Mention names, credential, a!liations of the developers, sponsors, and owners
Mention names, credential, avliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Consict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study no industry avliations subitem not at all important 1 2 3 4 5 essential 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The mROAD intervention was entirely SMS text message-based, given the low access to advanced mobile technology in this population [27]. mROAD is a unidirectional, automated system; it was set to start the day after a patient enrolled in the trial. Messages were delivered on a Health Insurance Portability and Accountability Act (HIPAA)-compliant system that was compatible with the local pay-as-you-go cellular plans that are popular in this patient population. The mROAD intervention was developed in English and then translated to Spanish, with back translation by two native Spanish speakers to ensure a clear translation. Patients received either the mROAD intervention (described below) or a week of sham SMS text messages so that patient willingness to receive messages could be assessed in both arms. The active control arm (sham) received a sham SMS text message greeting daily (eg, "Thanks for taking part!" or "), while the intervention group (mROAD) received two text messages about alcohol use daily for 7 days. The intervention SMS text messages were adapted from the National Institutes of Health publication Rethinking Drinking [39]. The messages were shortened to Pt the character limit of SMS text messages. The selected content included the consequences of drinking, motivational statements, and resources on how to obtain help to reduce drinking. Social norms theory and motivational interviewing strategies were emphasized, as supported by systematic reviews of the literature [40]. For example, social norms theory-based messages described normal drinking behavior, while motivational interviewing-based messages prompted participants to set a goal and write it down or type it out (see Figure 1 for example mROAD and sham messages).

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study not revised

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study ". The intervention SMS text messages were adapted from the National Institutes of Health publication Rethinking Drinking [39]. The messages were shortened to Pt the character limit of SMS text messages. The selected content included the consequences of drinking, motivational statements, and resources on how to obtain help to reduce drinking. Social norms theory and motivational interviewing strategies were emphasized, as supported by systematic reviews of the literature [40]. For example, social norms theory-based messages described normal drinking behavior, while motivational interviewing-based messages prompted participants to set a goal and write it down or type it out (see Figure 1 for example mROAD and sham messages)." 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing &owcha"s of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing sowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiPc reporting.

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study not relevant

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speciPc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "At recruitment, RAs informed the patient that they were at risk for hazardous alcohol use and invited them to receive SMS text messages upon enrolling. Patients were offered an incentive of a $10 gift card if they choose to enroll to offset the cost of receiving the SMS text messages. Patients were given both a verbal explanation of the project and a copy of the informed consent form. After agreeing to participate, participants were sequentially assigned to either the active control group or the intervention group. Next, patients were registered in the mHealth platform, which sent automated, unidirectional, broadcast SMS text messages for 1 week. Patients selected their preferred language for text messages as English or Spanish. Patients were not required to text a response to be enrolled. " subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The mROAD intervention was entirely SMS text message-based, given the low access to advanced mobile technology in this population [27]. mROAD is a unidirectional, automated system; it was set to start the day after a patient enrolled in the trial. Messages were delivered on a Health Insurance Portability and Accountability Act (HIPAA)-compliant system that was compatible with the local pay-as-you-go cellular plans that are popular in this patient population. The mROAD intervention was developed in English and then translated to Spanish, with back translation by two native Spanish speakers to ensure a clear translation. Patients received either the mROAD intervention (described below) or a week of sham SMS text messages so that patient willingness to receive messages could be assessed in both arms. The active control arm (sham) received a sham SMS text message greeting daily (eg, "Thanks for taking part!" or "), while the intervention group (mROAD) received two text messages about alcohol use daily for 7 days. The intervention SMS text messages were adapted from the National Institutes of Health publication Rethinking Drinking [39]. The messages were shortened to Pt the character limit of SMS text messages. The selected content included the consequences of drinking, motivational statements, and resources on how to obtain help to reduce drinking. Social norms theory and motivational interviewing strategies were emphasized, as supported by systematic reviews of the literature [40]. For example, social norms theory-based messages described normal drinking behavior, while motivational interviewing-based messages prompted participants to set a goal and write it down or type it out (see Figure 1 for example mROAD and sham messages). "

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The mROAD intervention was entirely SMS text message-based, given the low access to advanced mobile technology in this population [27]. mROAD is a unidirectional, automated system; it was set to start the day after a patient enrolled in the trial. Messages were delivered on a Health Insurance Portability and Accountability Act (HIPAA)-compliant system that was compatible with the local pay-as-you-go cellular plans that are popular in this patient population. The mROAD intervention was developed in English and then translated to Spanish, with back translation by two native Spanish speakers to ensure a clear translation. Patients received either the mROAD intervention (described below) or a week of sham SMS text messages so that patient willingness to receive messages could be assessed in both arms. The active control arm (sham) received a sham SMS text message greeting daily (eg, "Thanks for taking part!" or "), while the intervention group (mROAD) received two text messages about alcohol use daily for 7 days. The intervention SMS text messages were adapted from the National Institutes of Health publication Rethinking Drinking [39]. The messages were shortened to Pt the character limit of SMS text messages. The selected content included the consequences of drinking, motivational statements, and resources on how to obtain help to reduce drinking. Social norms theory and motivational interviewing strategies were emphasized, as supported by systematic reviews of the literature [40]. For example, social norms theory-based messages described normal drinking behavior, while motivational interviewing-based messages prompted participants to set a goal and write it down or type it out (see Figure 1 for example mROAD and sham messages). "

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study RAs screened, enrolled and registered patients into the system in person. No other involve was required for the intervention, only for follow up.

5-xi) Repo" any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study only intervention messages were sent subitem not at all important 1 2 3 4 5 essential 6a) Completely de!ned pre-speci!ed primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/suppo") Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study No training was performed.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Feasibility was dePned as >60% of eligible patients consenting and enrolling in the program and achieving 60% follow-up with participants. Previous studies with SBIRTs among ED patients yielded enrollment rates of 38%-87%, with follow-up rates between 49% and 89% [24,41,14]. For the few SMS text message-based alcohol interventions from the ED, followup rates have been between 75% and 82% [23,42,43]. However, previous work at our study site showed a maximum telephone follow-up rate of 70% for all comers [44]. To account for the lower anticipated follow-up rates for a low-income, non-English-speaking ED population in addition to patients with risky alcohol use, we determined 60% to be an acceptable followup rate. We dePned acceptability as greater than 90% of patients completing the 7 days of text messages without opting out by review of the mHealth platform service records. Our secondary acceptability outcome benchmark was 75% of participants agreeing with each statement in a brief, locally developed acceptability questionnaire. We also reported preliminary evcacy results with changes in days drinking alcohol, days heavily drinking, and desire to change drinking behavior. Preliminary evcacy results were compared to baseline and between groups with two-sample t tests without assumption of equal variance." 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de%ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was dePned/measured/monitored (logins, logPle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "We dePned acceptability as greater than 90% of patients completing the 7 days of text messages without opting out by review of the mHealth platform service records. " 6a-iii) Describe whether, how, and when qualitative feedback from pa"icipants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
6b) Any changes to trial outcomes a#er the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text

Your answer
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study No changes were made 7a-i) Describe whether and how expected a'rition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study This is a feasibility trial Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

None used
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "After agreeing to participate, participants were sequentially assigned to either the active control group or the intervention group." 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled pa"icipants, and who assigned pa"icipants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study N/A, not randomized Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 11a) If done, who was blinded a#er assignment to interventions (for example, pa"icipants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study N/A, not randomized 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

Does your paper address subitem 11a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 1 2 3 4 5 essential 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 11a-ii) Discuss e.g., whether pa"icipants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study N/A, not randomized Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Feasibility was dePned as >60% of eligible patients consenting and enrolling in the program and achieving 60% follow-up with participants. Previous studies with SBIRTs among ED patients yielded enrollment rates of 38%-87%, with follow-up rates between 49% and 89% [24,41,14]. For the few SMS text message-based alcohol interventions from the ED, followup rates have been between 75% and 82% [23,42,43]. However, previous work at our study site showed a maximum telephone follow-up rate of 70% for all comers [44]. To account for the lower anticipated follow-up rates for a low-income, non-English-speaking ED population in addition to patients with risky alcohol use, we determined 60% to be an acceptable followup rate. We dePned acceptability as greater than 90% of patients completing the 7 days of text messages without opting out by review of the mHealth platform service records. Our secondary acceptability outcome benchmark was 75% of participants agreeing with each statement in a brief, locally developed acceptability questionnaire. We also reported preliminary evcacy results with changes in days drinking alcohol, days heavily drinking, and desire to change drinking behavior. Preliminary evcacy results were compared to baseline and between groups with two-sample t tests without assumption of equal variance. 12a-i) Imputation techniques to deal with a'rition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).

Does your paper address subitem 12a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study n'a no imputation performed Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

RESULTS
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "At recruitment, RAs informed the patient that they were at risk for hazardous alcohol use and invited them to receive SMS text messages upon enrolling. Patients were offered an incentive of a $10 gift card if they choose to enroll to offset the cost of receiving the SMS text messages. Patients were given both a verbal explanation of the project and a copy of the informed consent form. After agreeing to participate, participants were sequentially assigned to either the active control group or the intervention group. Next, patients were registered in the mHealth platform, which sent automated, unidirectional, broadcast SMS text messages for 1 week. Patients selected their preferred language for text messages as English or Spanish. Patients were not required to text a response to be enrolled. "

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study No additional safety was required as integrated into usual care 13a) For each group, the numbers of pa"icipants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions a#er randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "2195 patients were identiPed by real time electronic tracking board review; 1167 could not be screened (see Figure 2 for exclusion reasons; the most common was that the patient was too ill to consent, n=825, 70.6%). Of the 1028 ED patients screened for alcohol use, 95 (9.2%) exhibited risky alcohol use based on AUDIT, and 72 (76%) of those patients owned an SMS text messaging-capable phone. Two-thirds of eligible patients (48/72, 67%) consented and were enrolled and registered in the mobile health platform. " Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT &ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Nearly two-thirds (31/48, 65%) of enrolled patients were successfully reached for follow-up; follow-up was higher in the intervention group (18/24, 75%) than in the control group (13/24, 54%). More patients in the intervention group reported receiving messages (17/18, 94%) than patients in the active control group (11/13, 85%)." subitem not at all important 1 2 3 4 5 essential 14a) Dates de!ning the periods of recruitment and follow-up

13b-i) A'rition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other Pgures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Pgure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Uploaded to manuscript Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Trained research assistants reviewed the ED electronic tracking board in real time between 7 AM and 11 PM over the course of 3 months (May through July 2014). " subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualiPcation, expertise, etc.) and centers (volume) in each group 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signiPcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study no changes Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not relevant, not stopped subitem not at all important 1 2 3 4 5 essential 16) For each group, number of pa"icipants (denominator) included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes, in manuscript 15-i) Repo" demographics associated with digital divide issues In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes, in Table 1 subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 16-i) Repo" multiple "denominators" and provide de%nitions Report multiple "denominators" and provide dePnitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speciPc pre-dePned time points of interest (in absolute and relative numbers per group). Always clearly dePne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study N/A, not used in analysis

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 17a) For each primary and secondary outcome, results for each group, and the estimated e&ect size and its precision (such as 95% con!dence interval) subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative e&ect sizes is recommended Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study N/A feasibility trial 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational dePnitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is dePned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 18) Results of any other analyses pe'ormed, including subgroup analyses and adjusted analyses, distinguishing pre-speci!ed from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study N/A feasibility trial Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Patients in both arms reported increased motivation to change drinking behavior, decreased days drinking any alcohol, and decreased days drinking heavily (see Table 3). Overall, participants reported increased motivation to change alcohol use, with an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) on the Change Questionnaire. The number of reported drinking days in the prior 30 days decreased by 5 (95% CI 1.7-8.3, P=.004 and heavy drinking days decreased by 4.1 (95% CI 1.0-7.15, P=.01). The differences in the changes between the arms were not signiPcant; however, the sham message arm overall trended toward larger improvements."

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

19) All impo"ant harms or unintended e&ects in each group
(for speciPc guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study N/A, not used in analysis Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study This was not measured/collected subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, sta"ing with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "In our study, patients in the sham message arm reported decreased drinking days, heavy drinking days and increased motivation to change drinking. The patients in the sham message arm started with higher reported drinking days, which correlates with larger decreases in risky alcohol behavior in prior ED-based SBIRTs [55,56]. Additionally, the followup rate was lower in the sham message arm; sham message patients who were followed up may be more motivated than the average ED patient. While the difference was not signiPcantly different from the theory-based message arm, there are several possible explanations if this Pnding is veriPed in fully powered studies. Patients receiving theorybased messages may become more aware of their drinking habits if they are reminded with messages pertaining to their drinking rather than sham messages alone. As a consequence, they may more accurately report their drinking frequency than the patients in the control group. This study did not have a usual care control group, as all patients were Prst informed in the ED during their initial contact that they were at risk for alcohol abuse. The minor intervention of daily SMS text messages linked to the ED-based screening may have promoted a change in the patients' habits." subitem not at all important Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study This feasibility trial suggests a true large RCT may be warranted.

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

21) Generalisability (external validity, applicability) of the trial !ndings
NPT: External validity of the trial Pndings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "While this proof-of-concept study is promising, it has several limitations. A strength of this study and of the mROAD program is the demonstration of the potential of a simple, easily scalable, automated system to encourage positive behavior changes; however, the small sample size, quasiexperimental design, and short follow-up period prevent conclusions about sustained behavior changes or differences between patients who received theorydriven vs sham messages. Patients in the sham message and theory-driven mROAD arms had similar reported changes in alcohol use and motivation to change; this indicates that either the sham messages after the in-ED screening and risk notiPcation had benePcial effects alone or that the natural history of an ED visit may include a decrease in alcohol use. Further study of this type of intervention may require a control group with less activation. This study was conducted at a single site, which may limit the generalizability of the feasibility Pndings. Additionally, the logistics of patient follow-up from an ED-based study that serves a low-income, non-English-speaking population creates potential for biased results due to differential follow-up."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Further study of this type of intervention may require a control group with less activation. This study was conducted at a single site, which may limit the generalizability of the feasibility Pndings. " 21-ii) Discuss if there were elements in the RCT that would be di$erent in a routine application se'ing Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

23) Registration number and name of trial registry
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "While mHealth extensions of in-ED SBIRTs are feasible, most EDs still do not conduct standardized screening and intervention, which limits their implementation [18]. However, promising work using patient self-administered and computer-based screening and notiPcation of risk provides an opportunity to increase the number of patients screened and referred to an mHealth extension of an SBIRT [47][48][49][50]. As more EDs move to selfadministered screening of behavioral risk factors and social determinants of health via computer, tablet, and mobile device interfaces, it may be possible to formally screen more patients for risky alcohol use [51,52]. Integrating formalized screening for alcohol behaviors increases implementation of screening and SBIRTs [53,54]. Increased screening could provide a larger target population, which could require increased resources at individual institutions. By using mHealth SBIRT strategies in combination with in-ED computer-based, tablet-based, and mobile device-based screening, the scope of SBIRTs can be increased. For clinics and EDs that already screen for risky alcohol use, similar mHealth extensions of screenings and brief interventions would require marginal extra workforce time. mHealth interventions hold potential to create large-scale programs to reduce risky drinking among ED patients without increasing demands on an already overstretched ED workforce." Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study ClinicalTrials.gov NCT02158949 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other suppo" (such as supply of drugs), role of funders X27) Con(icts of Interest (not a CONSORT item) Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study No, all listed in methods Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (Pnancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "EB designed the intervention and study, led the data analysis, wrote the Pnal manuscript, and takes full responsibility for the accuracy of the work. MZ contributed to the data analysis, wrote the Prst draft of the manuscript, and participated in the revision of the Pnal manuscript. MZ, KFB, JL, and JT led the data collection, designed and implemented the follow-up strategies, and participated in drafting and editing the Pnal manuscript. CNL contributed to and conducted the data analysis plan. MM, ST, and SA contributed equally as senior mentors to the design of the study and to drafting and editing the manuscript."