A Research Study Will Compare A New Combined implementation strategy with a standard educational approach for delivering community occupational therapy (COT) to individuals with dementia and their caregivers. This single-blinded, cluster randomized controlled trial aims to determine the effectiveness and cost-effectiveness of the combined strategy in improving adherence to the COTiD program and increasing referrals to community OT.
Study Design and Participants
The study employs a cluster randomized controlled design, stratifying clusters by setting (hospital, nursing home, mental health services) and randomizing them to either a control group (educational strategy) or an experimental group (combined implementation strategy). A 2:1 allocation ratio (control vs. experimental) was used, anticipating higher referral rates from physicians in the experimental group. Data collection is carried out by three research assistants blinded to group allocation.
Figure 1: Study Design Flowchart. This flowchart visually represents the study’s design, outlining the process from participant recruitment to data analysis.
Participating clusters comprise occupational therapists (OTs), managers, and physicians working in community OT settings. Eligibility criteria for clusters include a minimum of two OTs, one physician, and one manager; provision of outpatient OT treatment; capacity to include at least eight client-caregiver pairs; and completion of a post-graduate COTiD program course by OTs.
Client-caregiver pairs, consisting of individuals with mild to moderate dementia and their caregivers, are enrolled during the first year. Eligibility criteria include a Mini-Mental State Examination (MMSE) score of 10-24; referral to a participating OT; living at home; caregiver involvement at least twice weekly; absence of severe depression, behavioral/psychological symptoms, or illnesses preventing participation; and consent from both client and caregiver.
Intervention Strategies
The educational strategy involves no intervention beyond a basic three-day post-graduate COTiD program course for OTs, focusing on background theory and skill training.
The combined implementation strategy (CI-strategy) supplements the post-graduate course with: implementation training days; on-the-job coaching; regional meetings; a web-based reporting system and discussion forum; a website and newsletters for professionals; and telephone calls to managers and physicians. This multifaceted approach addresses barriers identified in a pilot study, aiming to improve knowledge and facilitate the implementation of the COTiD program.
Outcome Measures and Sample Size
Primary outcome measures include the number of clients referred to community OT according to the COTiD program and OT adherence to the program, measured using vignettes and a close-ended questionnaire. Secondary outcome measures assess professional knowledge about COTiD and client-caregiver outcomes such as quality of life. Data is collected from professionals at baseline, 6, and 12 months, and from client-caregiver pairs at baseline, 3, 6, 9, and 12 months.
Sample size calculations, based on anticipated increases in adherence and community OT use, determined a sample size of 30 clusters in the control group and 15 in the intervention group, providing sufficient power to detect meaningful changes.
Ethical Considerations and Statistical Analysis
Ethical approval was obtained, and informed consent is required from all participants. Data analysis will employ random effects regression models to compare differences between groups, considering baseline scores and clustering effects. T-tests and ANOVA will be used to analyze differences in knowledge levels among professionals. Economic evaluation will assess cost-effectiveness from a societal perspective, considering both healthcare and societal costs. A process evaluation will explore factors influencing the success or failure of the CI-strategy using qualitative methods such as focus groups and interviews.
