Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC): study...

The prevalence of frailty increases with older age. Frail and/or multimorbid patients are at risk for experiencing a crisis. Crises are major stressors for the patient, informal caregivers and formal caregivers and often lead to adverse events and hospitalization. The ongoing effectiveness study in the Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC) study is a cluster randomized controlled trial. This study will test the effectiveness of an adapted version of a biopsychosocial person-centred model, the Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME), to prevent and resolve crises for frail community-dwelling people receiving home care services. This current study protocol describes the process evaluation that will be conducted in parallel with the effectiveness study. The aims of this process evaluation are to explore factors and areas of importance in further implementation of the TIME model in home care services in Norway and to make causal assumptions about the effectiveness or lack of effectiveness of the intervention.

The process evaluation will use mixed methods and integrate an exploratory and convergent design. To guide the process evaluation, we will use the Practical, Robust Implementation and Sustainability Model (PRISM) and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) frameworks for following and evaluating the intervention with TIME. Data collection from municipal staff and home care service leaders will focus on the RE-AIM dimensions. Qualitative data will be obtained through focus group interviews and local project group meetings and analysed using thematic analyses. Quantitative data will be collected by staff questionnaires and will be analysed using descriptive statistics.

The PRACTIC study will enhance innovation in the development of new knowledge and a new approach towards each patient. This process evaluation will allow for a better understanding of the intervention and implementation of the complex TIME intervention in home care services. By analysing the RE-AIM dimensions, we will make causal assumptions about the effectiveness of the intervention. The findings will provide comprehensive knowledge of areas and factors of importance for the implementation of TIME in home care services.

Parent trial NCT05651659 (ClinicalTrials.gov), first registered on 15th December 2022.