Effectiveness and Implementation of Montessori Approaches in Person-Centered Care Within VA

NCT04829500 | Active Not Recruiting DMC

• 1 other identifier: IIR 19-413
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in resident agitation from pre-intervention to post-intervention

  Staff-reported observations of resident agitation will be collected over time using the Cohen-Mansfield Agitation Inventory (CMAI). The CMAI is a widely used, valid measure of agitation frequency for older adults across diagnoses in NH settings. Staff rate 29 behaviors over the past two weeks (1=never to 7=several times/hr) across four subscales: verbally nonaggressive behaviors, verbally aggressive behaviors, physically nonaggressive behaviors, and physically aggressive behaviors. Higher scores indicate more agitation.

  Primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated)

Secondary Outcomes (3)

• Change in resident mood from pre-intervention to post-intervention

  Primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated)

• Change in resident psychotropic medication use from pre-intervention to post-intervention

  Monthly pharmacy data will be examined pre-and post-intervention for time trends.

• Change in patient-centered care practices / organizational culture from pre-intervention to post-intervention

  Primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated)

Study Arms (2)

Pre-Intervention Baseline Collection Phase

NO INTERVENTION

All sites will start with a baseline collection phase without exposure to the intervention, consistent with the stepped wedge cluster randomized trial design. A sequential randomized crossover to the intervention (MAP-VA) will be assigned, which cannot be reversed once it has been introduced.

MAP-VA Intervention

EXPERIMENTAL

Montessori approaches to person-centered care (MAP-VA) introduces practical strategies that frontline staff can use for successful engagement of residents through retained abilities such as implicit learning, procedural memory, reading abilities. Staff training provides practice with: 1) pre-developed activities and templates, 2) a simple reading assessment to inform development of external cues; and 3) identifying opportunities for increased independence and resident contribution to community routines. Staff are also introduced to concrete strategies that improve dignity, control, and independence.

Behavioral: Montessori Approaches to Person-Centered Care (MAP-VA)

Interventions

Montessori Approaches to Person-Centered Care (MAP-VA) BEHAVIORAL

Montessori approaches to person-centered care (MAP-VA) introduces practical strategies that frontline staff can use for successful engagement of residents through retained abilities. Staff are also introduced to concrete strategies that improve dignity, control, and independence. MAP-VA is based on the work of Maria Montessori who demonstrated that a structured, supportive environment and meaningful, active roles in the classroom enabled children to fulfill their greatest potential physically, mentally, and emotionally. Montessori principles have been applied to dementia care for more than 20 years to promote functional independence, meaningful engagement, and dignity.

Also known as: Montessori Activity Programming, Montessori Inspired Lifestyle, Montessori for Dementia

MAP-VA Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Residents admitted for hospice or respite care

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Center for Applied Research in Dementia: collaborator
• University of Alabama at Birmingham: collaborator
• Providence VA Medical Center: collaborator
• Edith Nourse Rogers Memorial Veterans Hospital: collaborator
• The VA Western New York Healthcare System: collaborator
• VA Salt Lake City Health Care System: collaborator

Study Sites (1)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404-5015, United States

Location

Related Publications (1)

• 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.

  PMID: 39039035 RESULT

MeSH Terms

Conditions

Dementia; Aggression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Personal Satisfaction

Study Officials

• Michelle Marie Hilgeman, PhD

  Tuscaloosa VA Medical Center, Tuscaloosa, AL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: November 1, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after all primary manuscripts and reports have been completed after study closure.

Locations

US (1)