Shared Decision-Making Training for Home Care Teams to Engage Frail Older Adults and Caregivers in Housing Decisions: Stepped-Wedge Cluster Randomized Trial

Background Frail older adults and caregivers need support from their home care teams in making difficult housing decisions, such as whether to remain at home, with or without assistance, or move into residential care. However, home care teams are often understaffed and busy, and shared decision-making training is costly. Nevertheless, overall awareness of shared decision-making is increasing. We hypothesized that distributing a decision aid could be sufficient for providing decision support without the addition of shared decision-making training for home care teams. Objective We evaluated the effectiveness of adding web-based training and workshops for care teams in interprofessional shared decision-making to passive dissemination of a decision guide on the proportion of frail older adults or caregivers of cognitively-impaired frail older adults reporting active roles in housing decision-making. Methods We conducted a stepped-wedge cluster randomized trial with home care teams in 9 health centers in Quebec, Canada. Participants were frail older adults or caregivers of cognitively impaired frail older adults facing housing decisions and receiving care from the home care team at one of the participating health centers. The intervention consisted of a 1.5-hour web-based tutorial for the home care teams plus a 3.5-hour interactive workshop in interprofessional shared decision-making using a decision guide that was designed to support frail older adults and caregivers in making housing decisions. The control was passive dissemination of the decision guide. The primary outcome was an active role in decision-making among frail older adults and caregivers, measured using the Control Preferences Scale. Secondary outcomes included decisional conflict and perceptions of how much care teams involved frail older adults and caregivers in decision-making. We performed an intention-to-treat analysis. Results A total of 311 frail older adults were included in the analysis, including 208 (66.9%) women, with a mean age of 81.2 (SD 7.5) years. Among 339 caregivers of cognitively-impaired frail older adults, 239 (70.5%) were female and their mean age was 66.4 (SD 11.7) years. The intervention increased the proportion of frail older adults reporting an active role in decision-making by 3.3% (95% CI –5.8% to 12.4%, P=.47) and the proportion of caregivers of cognitively-impaired frail older adults by 6.1% (95% CI -11.2% to 23.4%, P=.49). There was no significant impact on the secondary outcomes. However, the mean score for the frail older adults’ perception of how much health professionals involved them in decision-making increased by 5.4 (95% CI −0.6 to 11.4, P=.07) and the proportion of caregivers who reported decisional conflict decreased by 7.5% (95% CI −16.5% to 1.6%, P=.10). Conclusions Although it slightly reduced decisional conflict for caregivers, shared decision-making training did not equip home care teams significantly better than provision of a decision aid for involving frail older adults and their caregivers in decision-making. Trial Registration ClinicalTrials.gov NCT02592525; https://clinicaltrials.gov/show/NCT02592525


INTRODUCTION 2a-i) Problem and the type of system/solution
Yes. "The aim of this study was to evaluate the effectiveness of adding a blended web-based and in-person training program in interprofessional SDM for home care teams to passive dissemination of a decision guide on the proportion of frail elders or caregivers reporting an active role in making housing decisions, compared with passive dissemination of the decision guide." 2a-ii) Scientific background, rationale: What is known about the (type of) system Yes. "In previous work, an interprofessional SDM training program for home care teams with a decision guide increased by 12% the proportion of caregivers who reported being active in making housing decisions for frail elders with cognitive impairment, compared to usual care.
[10] However, other studies have shown that educational interventions may make little difference to the actual practice of SDM with elders with cognitive impairment and their surrogate decision makers [11]. In addition, home care teams are already very busy and overall awareness of SDM is increasing.
[12] Passively disseminating decision guides alone could thus be enough to increase patient engagement in decision making.
[13] However, their effectiveness alone, compared to as part of a multifaceted intervention, is unknown." Does your paper address CONSORT subitem 2b?
Yes. "We hypothesized that the addition of a training program in IP-SDM to the passive dissemination of a decision guide would increase the proportion of frail elders or caregivers reporting an active role in the decision-making process. " METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio Yes. "We conducted a cross-sectional stepped-wedge cluster randomized trial (the IPSDM-SW Study) from November 2014 to December 2018 with the home care teams of health centers in Quebec, Canada." 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons Yes."Due to practical constraints, some health centers started the intervention earlier or later than planned." 3b-i) Bug fixes, Downtimes, Content Changes No Bug fixes, Downtimes or Content Changes. We change introduced is the following one : "Due to practical constraints, some health centers started the intervention earlier or later than planned." 4a) CONSORT: Eligibility criteria for participants Yes. " Frail elders were eligible if they: (1) were aged ≥65; (2) were receiving care from the home care teams; (3) had made a decision about staying home or moving during the recruitment periods; (4) were able to read, understand and write French or English; (5) were able to give informed consent. When frail elders were cognitively-impaired, their informal caregiver became the eligible participant. Caregivers were defined in this study as close relatives or friends and were eligible if they: (1) were caring for a cognitively-impaired elder who was otherwise eligible; (2) were able to read, understand, and write French or English; and (3) provided informed consent to participate in the study." 4a-i) Computer / Internet literacy Yes. all the health professionals of the participating home care teams were "de facto" eligible to access to the web-tutorial. "The intervention consisted of (1) a 1.5 hour web-based tutorial, based on the Ottawa Decision Support Tutorial,[19] completed individually by the health professionals of the participating home care teams at the cluster level; followed by (2) a 3.5 hour live interactive workshop" 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Yes. Participants were recruited offline. "Study participants, recruited offline, were frail elders with loss of autonomy and caregivers of frail elders with cognitive impairment recruited through the home care teams of the health centers" 4a-iii) Information giving during recruitment Yes. "Home care teams made lists of potentially eligible frail older patients. Trained RAs assigned to each health center contacted these patients or caregivers of frail elders with cognitive impairment and asked if they would participate. Then RAs met all interested participants at their home or a place of their choice to complete informed consent and proceed with data collection." 4b) CONSORT: Settings and locations where the data were collected Yes. "We conducted a cross-sectional stepped-wedge cluster randomized trial (the IPSDM-SW Study) from November 2014 to December 2018 with the home care teams of health centers in Quebec, Canada" 4b-i) Report if outcomes were (self-)assessed through online questionnaires Yes. "Self-reported data collected were outcomes, relationship between caregivers and frail elders (when appropriate) and sociodemographic characteristics including age, sex, and education, variables identified as predictors of our primary outcome: younger, female, and well-educated people (secondary school level or higher) are more likely to take an active role in decisions about their health" 4b-ii) Report how institutional affiliations are displayed Not aplicable. We did not display institutional affiliations to potential participants. And we pay attention to recruit similar participating health centers to be able to compare results easily. In addition the results did not vary by health center (cluster) 5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Yes. "The web-based tutorial ensured that all participants arrived at the workshop with a similar knowledge of SDM concepts. The workshop included a lecture reviewing SDM concepts (especially the interprofessional SDM approach); a video demonstrating the approach in a home care team with a frail elder making a housing decision [20]; training in using the decision guide[4]; and role play using the decision guide with feedback from facilitators. [15,20] The workshop, based on adult education principles, [21] included decision-making about housing decisions with frail elders, communication techniques and, for frail elders with cognitive impairment, strategies for fostering their participation or that of their caregivers in decision-making. Workshops were held in health center premises and were similarly offered (same content, same materials, same trainers) on a single occasion.
[15] All home care teams received the intervention at various time points. The decision guide distributed before the intervention was still available in sufficient quantities afterwards.
[15] The digital format of the initial tutorial and the video were convenient and easily scalable to our 9 intervention sites, and ensured that base elements of the training were standardized and identical. This is helpful in stepped-wedge trials, where control and intervention conditions are experienced at different times, there is implementation lag, and individuals are exposed to the intervention in different ways and locations. It also reduced time expenditure and costs, in contrast to in-person training, which had to be repeated at each crossover point.
[22] However, our intervention overcame the disadvantages of web-based learning (mainly isolation) [23][24][25], by the in-person part of the training, which provided role play, feedback and discussion opportunities for applying knowledge to skills and behavior.[26]" 5-ii) Describe the history/development process Yes, and we provided a reference for more details."The intervention consisted of (1) a 1.5 hour web-based tutorial, based on the Ottawa Decision Support Tutorial,[19] completed individually by the health professionals of the participating home care teams at the cluster level; followed by (2) a 3.5 hour live interactive workshop. The web-based tutorial ensured that all participants arrived at the workshop with a similar knowledge of SDM concepts"

5-iii) Revisions and updating
No revision or update was made. We had one intervention and one comparator 5-iv) Quality assurance methods Not applicable, we did not need to 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Yes, the web component of our intervention is available online on a site whose references we have provided to ensure reproducibility. "It was accessible by registration on the site [18] and has the potential to help health professionals discuss with frail elders of caregivers of cognitively-impaired frail elders the decision about the location of care [4, 9, 13]. " ; [18] described the website.

5-vi) Digital preservation
Yes. "Dissemination of the decision guide was passive in the sense that although distributed in the health centers, we did not train the teams in how to use it. The decision guide, adapted from the online family decision support tool to the context of the home was developed in French and English versions [4,18]." [18] is https://decisionaid.ohri.ca/ODST/ 5-vii) Access Yes. "It was accessible by registration on the site [18] and has the potential to help health professionals discuss with frail elders of caregivers of cognitivelyimpaired frail elders the decision about the location of care [4, 9, 13]." 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework yes. "The workshop, based on adult education principles, [21] included decision-making about housing decisions with frail elders, communication techniques and, for frail elders with cognitive impairment, strategies for fostering their participation or that of their caregivers in decision-making. Workshops were held in health center premises and were similarly offered (same content, same materials, same trainers) on a single occasion.
[15] All home care teams received the intervention at various time points. The decision guide distributed before the intervention was still available in sufficient quantities afterwards.
[15] The digital format of the initial tutorial and the video were convenient and easily scalable to our 9 intervention sites, and ensured that base elements of the training were standardized and identical. This is helpful in stepped-wedge trials, where control and intervention conditions are experienced at different times, there is implementation lag, and individuals are exposed to the intervention in different ways and locations. It also reduced time expenditure and costs, in contrast to in-person training, which had to be repeated at each crossover point.
[22] However, our intervention overcame the disadvantages of web-based learning (mainly isolation) [23][24][25], by the in-person part of the training, which provided role play, feedback and discussion opportunities for applying knowledge to skills and behavior.
[26]" 5-ix) Describe use parameters Not applicable. There is no intended "doses" and optimal timing for use.

5-x) Clarify the level of human involvement
Yes. intervention targeted health professionals, "The intervention consisted of (1) a 1.5 hour web-based tutorial, based on the Ottawa Decision Support Tutorial,[19] completed individually by the health professionals of the participating home care teams at the cluster level; followed by (2) a 3.5 hour live interactive workshop. " 5-xi) Report any prompts/reminders used we did not use a specific recall and this is one of the limitations of our study. "Periodic reminders[61] and post-intervention coaching could have increased long-term effects and fidelity.
[62] Changing clinical, organizational and policy-making environments can have major impacts on pragmatic trials such as ours." 5-xii) Describe any co-interventions (incl. training/support) Not applicable. In the study we did not have any co-intervention to describe. 6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed yes,"The primary outcome was the frail elders' or caregivers' perception of the role they assumed in decision-making as measured using a modified version of the Control Preferences Scale,[27] a single question with five response categories: (A) I made the decision, (B) I made the decision after seriously considering the healthcare professionals' opinions, (C) the healthcare professionals and I shared the responsibility for the decision making, (D) the healthcare professionals made the decision after seriously considering my opinion, and (E) the healthcare professionals made the decision. For sample size calculation and analysis, we dichotomized the primary outcome by collapsing categories A, B and C into "active role" and D and E into "passive role" in decision-making. Secondary outcomes assessed in frail elders and caregivers were (1) their preferred option about whether the cognitively older adult should stay at home or move to another location, and the actual decision made; (2) decisional conflict, assessed with the 16-item Decisional Conflict Scale[28, 29]; (3) decision regret, assessed with the 5-item Decision Regret Scale [30]; and (4) and perception of the extent to which health professionals involved them in decisionmaking, assessed with the D-OPTION scale, a 12-item instrument evaluating SDM behaviors during decision-making.[31, 32] Secondary outcomes for frail elders alone was health-related quality of life , assessed with the 36 -items of the Nottingham Health Profile ,[33-35] and for caregivers alone, burden of care, assessed with the Zarit Burden Inventory scale.[36-38]" 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed Not applicable. No online questionnaire was used in the study. 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Not applicable. For the online tutorial, no dose was relevant: the health professional have to complete the tutorial 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained yes. "However, our intervention overcame the disadvantages of web-based learning (mainly isolation) [23][24][25], by the in-person part of the training, which provided role play, feedback and discussion opportunities for applying knowledge to skills and behavior.
[26]" 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons Yes. "We conducted a cross-sectional stepped-wedge cluster randomized trial (the IPSDM-SW Study) from November 2014 to December 2018 with the home care teams of health centers in Quebec, Canada" 7a) CONSORT: How sample size was determined 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Yes. "The sample size calculation was informed by preliminary data from another study.
[42] We used the method developed by Hussey and Hughes for stepped-wedge designs.
[43] We assumed an average of eight frail elders and eight caregivers per health center in each data collection period and a timeindependent intra-class correlation (ICC) of 0.05.[44] To detect an absolute increase of 20%[45] in the primary outcome (from 70% to 90%) with 80% power using a stepped-wedge design with four sequences and a two-sided test at the 5% significance level, a total of eight clusters (with a total of 320 caregivers) was required,[46] meaning 320 frail elders and 320 caregivers of frail elders with cognitive impairment. To prevent any loss to follow-up of clusters, we recruited one more health center than planned." 7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines yes,"The primary outcome was the frail elders' or caregivers' perception of the role they assumed in decision-making as measured using a modified version of the Control Preferences Scale,[27] a single question with five response categories: (A) I made the decision, (B) I made the decision after seriously considering the healthcare professionals' opinions, (C) the healthcare professionals and I shared the responsibility for the decision making, (D) the healthcare professionals made the decision after seriously considering my opinion, and (E) the healthcare professionals made the decision. For sample size calculation and analysis, we dichotomized the primary outcome by collapsing categories A, B and C into "active role" and D and E into "passive role" in decision-making. Yes. "Health centers (clusters) were randomized to one of four sequences. Once participating home care teams had been identified, an independent biostatistician at the Ottawa Hospital Research Institute's Methods Centre performed randomization using computer-generated numbers. Given the nature of the intervention, the investigators, project coordinator and research assistants (RAs) collecting the data were not blinded. However, the allocation list was concealed from the research team for as long as possible and RAs were asked not to discuss this information with any frail elder or caregiver and not to refer to the intervention. Frail elders and caregivers were blinded to the intervention." 8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) Yes. "Health centers (clusters) were randomized to one of four sequences. Once participating home care teams had been identified, an independent biostatistician at the Ottawa Hospital Research Institute's Methods Centre performed randomization using computer-generated numbers. Given the nature of the intervention, the investigators, project coordinator and research assistants (RAs) collecting the data were not blinded. However, the allocation list was concealed from the research team for as long as possible and RAs were asked not to discuss this information with any frail elder or caregiver and not to refer to the intervention. Frail elders and caregivers were blinded to the intervention." 9) CONSORT: 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 Yes. "an independent biostatistician at the Ottawa Hospital Research Institute's Methods Centre performed randomization using computer-generated numbers." 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Yes. "an independent biostatistician at the Ottawa Hospital Research Institute's Methods Centre performed randomization using computer-generated numbers." 11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't Yes. "Given the nature of the intervention, the investigators, project coordinator and research assistants (RAs) collecting the data were not blinded. However, the allocation list was concealed from the research team for as long as possible and RAs were asked not to discuss this information with any frail elder or caregiver and not to refer to the intervention. Frail elders and caregivers were blinded to the intervention." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Yes. Particpants ehen applicable were only aware of the intervention but they did know what was the comparator. "Home care teams made lists of potentially eligible frail older patients. Trained RAs assigned to each health center contacted these patients or caregivers of frail elders with cognitive impairment and asked if they would participate. Then RAs met all interested participants at their home or a place of their choice to complete informed consent and proceed with data collection. Data collection took place from November 2015 to December 2018. Due to practical constraints, some health centers started the intervention earlier or later than planned. Self-reported data collected were outcomes, relationship between caregivers and frail elders (when appropriate) and sociodemographic characteristics including age, sex, and education, variables identified as predictors of our primary outcome: younger, female, and well-educated people (secondary school level or higher) are more likely to take an active role in decisions about their health [27,[39][40][41]." 11b) CONSORT: If relevant, description of the similarity of interventions Not relevant for the study 12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes Yes. "The primary outcome was analyzed using a generalized linear mixed model (GLMM) with logit link. The pre-specified primary analysis assumed a uniform within-and between-period correlation, adjusting for time effects (categorical) and specifying a random effect for cluster.
[43]" 12a-i) Imputation techniques to deal with attrition / missing values Yes. Missing value rate is very low (less than 5%) and we did not use imputation method. "Missing data rate is 98%." I addition, there was no attrition dur to the crosssectional nature of the stepped wedge. However no health center was loss to follow-up or refused to continue the study. "There was no loss to follow-up of health centers and no frail elders, caregivers or health centers were excluded". 12b) CONSORT: Methods for additional analyses, such as subgroup analyses and adjusted analyses Yes. "We performed secondary analyses by additionally adjusting for primary outcome predictors and for imbalanced baseline characteristics. [47,48] To explore the implications of bias due to misspecification of the correlation structure,[49] we conducted analyses using two other correlation structures identified in the literature: nested exchangeable (specifying a random cluster effect and a random time by cluster interaction)[50, 51] and exponential decay (an autoregressive between-period correlation).
[52] There are no guidelines for choosing the best-fitting covariance structure, so we used the pseudo-AIC information criteria to select the best-fitting model and presented the results as sensitivity analyses." RESULTS 13a) CONSORT: For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome Yes. "Of 481 frail elders contacted, 311 (64.6%) were recruited. Of 502 eligible caregivers contacted, 339 (67.5%) were recruited. " 13b) CONSORT: For each group, losses and exclusions after randomisation, together with reasons Yes . "There was no loss to follow-up of health centers and no frail elders, caregivers or health centers were excluded (Figure 1). Sociodemographics of frail elders and caregivers were well balanced between allocated sequences." 13b-i) Attrition diagram Yes. " Figure 1: Flowchart for the trial by allocated sequence and period" 14a) CONSORT: Dates defining the periods of recruitment and follow-up Yes. "Recruitment took place from November 2014 to December 2018. Interprofessional home care teams from nine health centers with 281 health professionals participated in the study" 14a-i) Indicate if critical "secular events" fell into the study period No change in the the internet resources fell into the study period. 14b) CONSORT: Why the trial ended or was stopped (early) The stepped wedge cluster randomized trial was completed 15) CONSORT: A table showing baseline demographic and clinical characteristics for each group Yes. " Table 2 : Baseline characteristics of participants" 15-i) Report demographics associated with digital divide issues Yes. "Participating frail elders were on average 81.2 (SD: 7.5) years old; 66.9% were female and 58.8% had secondary education or higher. Baseline characteristics were well-balanced between intervention and control except for education level (Table 1). Caregivers of frail elders with cognitive impairment were on average 66.4 years old (SD: 11.7); 70.5% were female and 87.3% had secondary education. Most caregivers (72%) were retired or at home and 90.3% were the child, spouse, or husband of the frail elder. Among caregivers, baseline characteristics were well-balanced between intervention and control, except for age (Table 2)." 16a) CONSORT: For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide definitions Yes. "Of 481 frail elders contacted, 311 (64.6%) were recruited. Of 502 eligible caregivers contacted, 339 (67.5%) were recruited. There was no loss to follow-up of health centers and no frail elders, caregivers or health centers were excluded (Figure 1)"

16-ii) Primary analysis should be intent-to-treat
Yes. "We performed analyses by the intention-to-treat principle with the frail elder or caregiver as the unit of analysis. The primary outcome was analyzed using a generalized linear mixed model (GLMM) with logit link. The pre-specified primary analysis assumed a uniform within-and between-period correlation, adjusting for time effects (categorical) and specifying a random effect for cluster.[43]" 17a) CONSORT: For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Yes. "). In all, 92.1% of frail elders recruited under the control condition reported an active role in decision-making versus 94.3% of frail elders recruited under the intervention condition for an absolute increase of 3.3% (95% CI, -5.8% to 12.4%; P=.47) after accounting for the secular trend (Table 3). Similarly, 77.8% caregivers recruited under the control condition reported an active role in decision-making versus 80.8% under the intervention condition for an absolute increase of 6.1% (95% CI, -11.8% to 23.4%; P=.49) " 17a-i) Presentation of process outcomes such as metrics of use and intensity of use Not applicable in out study. Our design was crossectional and no dose effect was assessed. 17b) CONSORT: For binary outcomes, presentation of both absolute and relative effect sizes is recommended Yes. "To estimate the absolute difference, as required by the CONSORT extension for stepped-wedge cluster randomized trials,[14] when dealing with binary outcomes, we applied GLMM using an identity link with the adaptative Gaussian-Hermite approximation to the likelihood maximum.
[53] " 18) CONSORT: Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Yes, "We performed secondary analyses by additionally adjusting for primary outcome predictors and for imbalanced baseline characteristics.[47, 48] " 18-i) Subgroup analysis of comparing only users

19) CONSORT: All important harms or unintended effects in each group
We did not perform subgroup analyses 19-i) Include privacy breaches, technical problems Not applicable, no physical harm was identified in the study 19-ii) Include qualitative feedback from participants or observations from staff/researchers