Health TAPESTRY Ontario: A Multi-Site Randomized Controlled Trial Testing Implementation and Reproducibility

Abstract

Purpose: Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a complex primary care program aimed at assisting older adults to stay healthier for longer. This study evaluated the feasibility of implementation across multiple sites, and the reproducibility of the effects found in the previous randomized controlled trial.

Methods: This was a pragmatic, unblinded, 6-month parallel group randomized controlled trial. Participants were randomized (intervention or control) using a computer-generated system. Eligible patients, aged 70 years and older, were rostered to 1 of 6 participating interprofessional primary care practices (urban and rural). In total, 599 (301 intervention, 298 control) patients were recruited from March 2018 through August 2019. Intervention participants received a home visit from volunteers to collect information on physical and mental health, and social context. An interprofessional care team created and implemented a plan of care. The primary outcomes were physical activity and number of hospitalizations.

Results: Based on the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, Health TAPESTRY had widespread reach and adoption. In the intention-to-treat analysis (257 intervention, 255 control), there were no statistically significant between-group differences for hospitalizations (incidence rate ratio = 0.79; 95% CI, 0.48-1.30; P = .35) or total physical activity (mean difference = -0.26; 95% CI, -1.18 to 0.67; P = .58). There were 37 non-study related serious adverse events (19 intervention, 18 control).

Conclusions: We found Health TAPESTRY was successfully implemented for patients in diverse primary care practices; however, implementation did not reproduce the effect on hospitalizations and physical activity found in the initial randomized controlled trial.

Trial registration: ClinicalTrials.gov NCT03397836.

Keywords: aged; health plan implementation; multimorbidity; primary health care; randomized controlled trial.

Figure 1.

CONSORT flow diagram of participants. CONSORT = consolidated standards of reporting trials. ^a All randomized individuals were included in the intention-to-treat analysis even if they did not receive follow-up.