MAP-VAMontessori Approaches in Person-Centered Care (MAP-VA): An Effectiveness-Implementation Trial in Community Living Centers

Specific Aims: A hybrid implementation-effectiveness study is necessary to evaluate MAP-VA for Veterans and staff in CLCs. Study Aims include: 1) evaluate implementation facilitation and identify barriers to MAP-VA adoption and fidelity; 2) determine effectiveness of MAP-VA implementation on resident behavioral, emotional, and physical health outcomes; 3) determine effectiveness of MAP-VA implementation on person-centered care practices and organizational culture; and 4) examine the extent to which MAP-VA is sustained after external facilitation support has ended. Methodology: A stepped-wedge cluster randomized controlled trial will be used to evaluate within- and between-cluster implementation success and treatment effects over 18 months. Eight CLCs (approximately 24 CLC neighborhoods) will be randomized to a sequential crossover to the intervention with six months of facilitation. Sequential balancing will be used during randomization to balance the sample over time. Analyses will account for time trends and correlations within cluster. Normalization process theory and the RE-AIM evaluation framework will guide the implementation evaluation and integration of qualitative and quantitative data. Data sources include primary data collection (e.g., resident interviews, staff interviews, surveys, researcher observation) and existing VA administrative data (e.g., Minimum Data Set 3.0, pharmacy, annual employee survey). The unit of analysis in hybrid implementation-effectiveness designs is typically at the system level (in the investigators' case the CLC/neighborhood) since existing staff provide the intervention. To address the research questions and corresponding aims, the study approach assesses both the clinical innovation (MAP-VA) and the implementation process itself (Blended Facilitation). Implementation process measures, fidelity, and outcome indicators will be tracked using a mixed methods evaluation approach. Common features of SW-CRTs utilized in this study include: 1) a baseline collection phase where no clusters are exposed to the intervention; 2) sequential randomized crossover to the intervention (MAP-VA), which cannot be reversed once it has been introduced; and 3) analyses that account for time trends and correlations within clusters. Randomization of facilities to MAP-VA will simply delay its rollout to sites randomized later in the sequence (like a wait-list control condition). Target sample size and analyses. A sample size of more than 200 CLC Staff and 96 Veteran residents are anticipated. Qualitative interview data will be analyzed using a content analytic approach. To test Aims 2 and 3 (effectiveness of MAP-VA) on the primary effectiveness outcome, scores for residents in the pre-intervention control condition will be compared to scores from residents in the intervention condition. GEE models with an identity link will be used to examine and compare means over time, with time considered a random effect. An indicator term will denote if the observation is pre- or post- intervention implementation, thus representing whether there was an overall difference during the intervention period versus the pre-intervention period. A centralized Data Safety Monitoring Board coordinated through the study sponsor (VA Health Services R\&D) will convene to review study materials annually.