Assessing the implementation and effectiveness of the Electronic Patient Reported Outcome Tool for Seniors with Complex Care Needs: Mixed Methods Study

Background: Goal-oriented care is being adopted to deliver person-centred primary care to older adults with multimorbidity and complex care needs. While this model holds promise, 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 evaluates the implementation and effectiveness of the electronic Patient Reported Outcome (ePRO) mobile application and portal system, designed to enable goal-oriented care delivery in inter-professional primary care practices. The research questions driving this study are: 1) Does ePRO improve quality of life and self-management in older adults with complex needs, and 2) what mechanisms are likely driving observed outcomes? Methods: A multi-method pragmatic randomized control 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 enrolment 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 mid-point 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 was analyzed using qualitative description and framework analysis methods. Results: Recruitment challenges resulted in fewer sites and participants than expected; only 142 of the 176 eligible patients were identified due to lower than expected provider participation and fewer than expected patients willing to participate or perceived as ready to engage in goal setting. Of 142 patients approached, 45 patients participated (32%). Patients set a variety of goals related to self-management, mental health, social health and overall well-being. Due to underpowering, the impact of ePRO on quality of life could not be definitively assessed; however the intervention group, ePRO plus usual care (M = 15.28, SD = 18.60), demonstrated non-significant slight decrease in quality of life, t(24)= -1.20, P = 0.24, when compared to usual care only (M = 21.76, SD = 2.17). The ethnographic data reveals a complex implementation process, in which the meaningfulness (or coherence) of the technology to individuals lives and work acted as a key driver to adoption and tool appraisal. Conclusion: 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 clinic settings, dynamic goal-oriented care process, and readiness of provider and patient participants. Trial Registration: ClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954?intr=epro&cntry=CA&rank=1 Keywords: older adults, goal-oriented care, quality of life, self-management, primary care, eHealth, pragmatic trial