Safer Care for Older Persons in (residential) Environments (SCOPE): a pragmatic controlled trial of a care aide-led quality improvement intervention

Background: The increased complexity of residents and increased needs for care in long-term care (LTC) have not been met with increased staffing. There remains a need to improve the quality of care for residents. Care aides, providers of the bulk of direct care, are well placed to contribute to quality improvement efforts but are often excluded from so doing. This study examined the effect of a facilitation intervention enabling care aides to lead quality improvement efforts and improve the use of evidence-informed best practices. The eventual goal was to improve both the quality of care for older residents in LTC homes and the engagement and empowerment of care aides in leading quality improvement efforts.

Methods: Intervention teams participated in a year-long facilitative intervention which supported care aide-led teams to test changes in care provision to residents using a combination of networking and QI education meetings, and quality advisor and senior leader support. This was a controlled trial with random selection of intervention clinical care units matched 1:1 post hoc with control units. The primary outcome, between group change in conceptual research use (CRU), was supplemented by secondary staff- and resident-level outcome measures. A power calculation based upon pilot data effect sizes resulted in a sample size of 25 intervention sites.

Results: The final sample included 32 intervention care units matched to 32 units in the control group. In an adjusted model, there was no statistically significant difference between intervention and control units for CRU or in secondary staff outcomes. Compared to baseline, resident-adjusted pain scores were statistically significantly reduced (less pain) in the intervention group (p=0.02). The level of resident dependency significantly decreased statistically for residents whose teams addressed mobility (p<0.0001) compared to baseline.

Conclusions: The Safer Care for Older Persons in (residential) Environments (SCOPE) intervention resulted in a smaller change in its primary outcome than initially expected resulting in a study underpowered to detect a difference. These findings should inform sample size calculations of future studies of this nature if using similar outcome measures. This study highlights the problem with measures drawn from current LTC databases to capture change in this population. Importantly, findings from the trial's concurrent process evaluation provide important insights into interpretation of main trial data, highlight the need for such evaluations of complex trials, and suggest the need to consider more broadly what constitutes "success" in complex interventions.

Trial registration: ClinicalTrials.gov , NCT03426072, registered August 02, 2018, first participant site April, 05, 2018.