TY - JOUR AU - Steele Gray, Carolyn AU - Chau, Edward AU - Tahsin, Farah AU - Harvey, Sarah AU - Loganathan, Mayura AU - McKinstry, Brian AU - Mercer, Stewart W AU - Nie, Jason Xin AU - Palen, Ted E AU - Ramsay, Tim AU - Thavorn, Kednapa AU - Upshur, Ross AU - Wodchis, Walter P PY - 2021 DA - 2021/12/2 TI - Assessing the Implementation and Effectiveness of the Electronic Patient-Reported Outcome Tool for Older Adults With Complex Care Needs: Mixed Methods Study JO - J Med Internet Res SP - e29071 VL - 23 IS - 12 KW - older adults KW - goal-oriented care KW - quality of life KW - self-management KW - primary care KW - eHealth KW - pragmatic trial KW - mobile phone AB - Background: Goal-oriented care is being adopted to deliver person-centered primary care to older adults with multimorbidity and complex care needs. Although this model holds promise, its implementation remains a challenge. Digital health solutions may enable processes to improve adoption; however, they require evaluation to determine feasibility and impact. Objective: This study aims to evaluate the implementation and effectiveness of the electronic Patient-Reported Outcome (ePRO) mobile app and portal system, designed to enable goal-oriented care delivery in interprofessional primary care practices. The research questions driving this study are as follows: Does ePRO improve quality of life and self-management in older adults with complex needs? What mechanisms are likely driving observed outcomes? Methods: A multimethod, pragmatic randomized controlled trial using a stepped-wedge design and ethnographic case studies was conducted over a 15-month period in 6 comprehensive primary care practices across Ontario with a target enrollment of 176 patients. The 6 practices were randomized into either early (3-month control period; 12-month intervention) or late (6-month control period; 9-month intervention) groups. The primary outcome measure of interest was the Assessment of Quality of Life-4D (AQoL-4D). Data were collected at baseline and at 3 monthly intervals for the duration of the trial. Ethnographic data included observations and interviews with patients and providers at the midpoint and end of the intervention. Outcome data were analyzed using linear models conducted at the individual level, accounting for cluster effects at the practice level, and ethnographic data were analyzed using qualitative description and framework analysis methods. Results: Recruitment challenges resulted in fewer sites and participants than expected; of the 176 target, only 142 (80.6%) patients were identified as eligible to participate because of lower-than-expected provider participation and fewer-than-expected patients willing to participate or perceived as ready to engage in goal-setting. Of the 142 patients approached, 45 (32%) participated. Patients set a variety of goals related to self-management, mental health, social health, and overall well-being. Owing to underpowering, the impact of ePRO on quality of life could not be definitively assessed; however, the intervention group, ePRO plus usual care (mean 15.28, SD 18.60) demonstrated a nonsignificant decrease in quality of life (t24=−1.20; P=.24) when compared with usual care only (mean 21.76, SD 2.17). The ethnographic data reveal a complex implementation process in which the meaningfulness (or coherence) of the technology to individuals’ lives and work acted as a key driver of adoption and tool appraisal. Conclusions: This trial experienced many unexpected and significant implementation challenges related to recruitment and engagement. Future studies could be improved through better alignment of the research methods and intervention to the complex and diverse clinical settings, dynamic goal-oriented care process, and readiness of provider and patient participants. Trial Registration: ClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954 SN - 1438-8871 UR - https://www.jmir.org/2021/12/e29071 UR - https://doi.org/10.2196/29071 UR - http://www.ncbi.nlm.nih.gov/pubmed/34860675 DO - 10.2196/29071 ID - info:doi/10.2196/29071 ER -