Discussion
usual stroke, stroke, multimorbidity, first-ever stroke
STROKE
To our knowledge, the TCSI Study is the first pragmatic RCT designed to enhance the quality and experience of hospital-to-home transitions for older adults with stroke and multimorbidity, 78% of whom had experienced their first-ever stroke, 94% of whom had four or more co-morbid conditions, and 87% of whom were taking four or more prescription medications daily. We found that although the TCSI did not improve hospital readmission rates (primary outcome), it produced greater gains in patient-reported physical functioning, stroke self-management and patient experience compared with usual stroke care. Notably, these improvements were achieved at no additional cost, from a societal perspective. Although we did not directly measure the acceptability of the intervention, the high engagement rate (93%) and low “dropout” rate (11%) over the six-month study period suggests that this approach is highly acceptable to this population.Our study is innovative for several reasons. First, it involved testing a TC intervention that focused on clinically complex older adults (with stroke and multimorbidity) who are often excluded from studies evaluating TC models [Our results are consistent with our previous RCT which studied an IP team approach to community-based stroke rehabilitation for older adults with stroke receiving home care services, that found improvements in physical functioning after 1 year [The finding that the TCSI resulted in greater improvements in stroke self-management is consistent with a systematic review that showed that self-management programs improved quality of life and self-efficacy in people with stroke [The finding that there were no significant group differences for the primary outcome [baseline to six-month risk of hospital readmission (all cause)] is likely a result of the lack of power (small sample size). The sample size for the trial was based on an effect size of 8% difference in the proportion hospitalized over the six-month intervention period observed in the previous Ontario feasibility study [The older adult participants in the present study are comparable to the general population of community-living adults with stroke described in the literature as reflected by their mean age (71 years) and the proportion of males (60%) [Our study has several strengths. A key strength of the trial is that it was highly pragmatic, using the criteria described in the PRECIS-2 tool [Noteworthy, is that one of the hospital-based outpatient stroke rehabilitation clinic study sites consisted of both urban and rural communities. People who live in rural areas may have difficulties in accessing health care due to a lack of services, isolation, or a lack of mobility [While many challenges arise conducting pragmatic trials testing complex interventions under ‘normal’ circumstances, managing a trial during a pandemic added an additional layer of complexity, resulting in many uncertainties and unique challenges. A noteworthy strength of the trial was our ability to work together to overcome a broad range of unique methodological and logistical challenges, including consenting and recruiting new participants, data collection and management, and intervention delivery, to name a few. An important strength of the trial was that we were able to revise the intervention from in-person to virtual delivery prior to initiating the intervention, which helped to lessen the impact of COVID on intervention delivery.