Clinical trial NCT04829500: Effectiveness and Implementation of Montessori Approaches in Person-Centered Care Within VA
Official title: Montessori Approaches in Person-Centered Care (MAP-VA): An Effectiveness-Implementation Trial in Community Living Centers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia or a Related Disorder
Mental Health Diagnoses
Symptoms of Agitation or Aggression
Keywords: dementia
mental health
residence characteristics
quality of health care
recreation
long-term care
quality of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Center for Applied Research in Dementia
name: University of Alabama at Birmingham
name: Providence VA Medical Center
name: Edith Nourse Rogers Memorial Veterans Hospital
name: The VA Western New York Healthcare System
name: VA Salt Lake City Health Care System
First posted: 2021-04-02
Enrollment: 356
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This 4-year, stepped-wedge cluster randomized trial (SW-CRT) uses a hybrid implementation-effectiveness design, and primary and administrative data collection to pursue four aims. Randomization in this hybrid implementation-effectiveness design is at the system level (in our case the CLC) 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Addressing behavioral and neuropsychiatric symptoms of Veterans with dementia and serious mental illness (SMI) such as schizophrenia can be challenging for staff in VA long-term care settings, called Community Living Centers or CLCs. These behaviors of distress (agitation, aggression, and mood disturbance) are not just associated with staff stress and burnout; they also hasten residents' functional decline, decrease quality of life, and increase mortality. Staff training in non-pharmacological interventions can be effective. Yet systems barriers, task-based care models, and time constraints often result in staff employing "quicker," less effective strategies. Montessori Approaches to Person-Centered Care for VA (MAP-VA)- a staff training, intervention, and delivery toolkit- developed in collaboration with VA operational partners, Veterans, and frontline CLC staff is positioned to respond to this challenge. The investigators' prior work shows probable impacts on CLC quality indicators at the individual and unit level (e.g., psychotropic medications, depressive symptoms, weight loss, falls, pain). The goal of this study is to evaluate the MAP-VA program and necessary supports for a successful implementation at 8 VA CLCs.

Significance/ Innovation: VHA's Modernization Plan focuses on empowering front-line staff to lead quality improvement efforts like the ones taught through MAP-VA. MAP-VA is distinct from existing interventions in its: 1) application to Veterans with a range of diagnoses and cognitive abilities; 2) emphasis on pairing practical skill-building for staff with overcoming system-level barriers that inhibit person-centered care; and 3) engagement of all staff rather than a reliance on provider-level champions. Yet, MAP-VA is a complex intervention that requires participation of multiple stakeholder groups, making implementation facilitation necessary. To date, no studies have evaluated MAP implementation success in operational settings (community or VA) and sustainability is rarely examined.

Aims: This 4-year study will examine both the effectiveness of the MAP-VA program on resident outcomes, person-centered care practices, and organizational culture as well as an evaluation of the implementation barriers to adopting MAP-VA in a sustainable way over a 12 month period. Staff and residents at 8 CLCs will participate in the study.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Residents who meet at least one of the following eligibility criteria will be eligible:

* dementia diagnosis or related disorder
* Cognitive Function Scale score indicative of impairment
* positive Patient Health Questionnaire (PHQ-9) depression score
* mental health diagnosis (e.g., ICD-10 codes)
* indication of agitation or aggression per MDS behavior items
* active prescription for a PRN or scheduled antipsychotic, sedative/hypnotic, or benzodiazepine/anxiolytic

Exclusion Criteria:

* Residents admitted for hospice or respite care

Primary outcomes:
measure: Change in resident agitation from pre-intervention to post-intervention
timeFrame: Primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated)
Secondary outcomes:
measure: Change in resident mood from pre-intervention to post-intervention
timeFrame: Primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated)
measure: Change in resident psychotropic medication use from pre-intervention to post-intervention
timeFrame: Monthly pharmacy data will be examined pre-and post-intervention for time trends.
measure: Change in patient-centered care practices / organizational culture from pre-intervention to post-intervention
timeFrame: Primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated)
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center, Tuscaloosa, AL
state: Alabama
Study officials:
affiliation: Tuscaloosa VA Medical Center, Tuscaloosa, AL
name: Michelle Marie Hilgeman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kennedy KA, Snow AL, Mills WL, Haigh S, Mochel A, Curyto K, Bishop T, Hartmann CW, Camp CJ, Hilgeman MM. Implementing Montessori approaches after training: A mixed methods study to examine staff understanding and movement toward action. Dementia (London). 2024 Oct;23(7):1126-1151. doi: 10.1177/14713012241263712. Epub 2024 Jul 22.