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Dementia or a Related DisorderMAP-VANCT04829500

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

A study testing Montessori Approaches to Person-Centered Care (MAP-VA) in people with Dementia or a Related Disorder and Mental Health Diagnoses, run by VA Office of Research and Development at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Montessori Approaches to Person-Centered Care (MAP-VA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
356 participants
Where
1 siteUnited States
Study dates
1 May 2021to 1 Nov 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Residents admitted for hospice or respite care

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tuscaloosa VA Medical Center, Tuscaloosa, AL

    Tuscaloosa, Alabama, 35404-5015

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Montessori Approaches to Person-Centered Care (MAP-VA)
Keywords
dementia, mental health, residence characteristics, quality of health care, recreation, long-term care, quality of life
Medical subject headings
Dementia, Aggression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Montessori Approaches to Person-Centered Care (MAP-VA)Behavioural

    Also called Montessori Activity Programming, Montessori Inspired Lifestyle, Montessori for Dementia

    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.

Study groups in NCT04829500
Study groupRoleWhat they receive
Pre-Intervention Baseline Collection PhaseNo interventionAll 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 InterventionExperimentalMontessori 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.
Receives: Behavioral: Montessori Approaches to Person-Centered Care (MAP-VA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Change in resident mood from pre-intervention to post-intervention

    Resident symptoms of depression will be assessed using the 9-item Patient Health Questionnaire (PHQ-9) or the PHQ-Observational (PHQ-OV) for residents who cannot self-report mood symptoms. Staff or residents will be asked to rate the frequency of symptoms over the past 2 weeks on a 4-point scale (0 = never or 1 day, to 3 = nearly every day). Higher scores indicate more mood symptoms.

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

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

    Psychotropic medication use will be extracted for individual residents enrolled in the study as well as examined at the unit-level using pharmacy data. Monthly administration rates of PRN anti-psychotics, benzodiazepines, and sedatives / hypnotics often used for agitation will be tracked.

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

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

    Staff-rated patient-centered care practices (e.g., atmosphere, individualized care and services) will be assessed using subscales of the Patient Centered Care Practices in Assisted Living (PC-PAL). Items are rated on a 4-point scale from 1 = strongly disagree to 4 = strongly agree, with higher scores indicating higher patient-centered care practices.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2021
  2. Study start1 May 2021
  3. Primary completion31 Dec 2024
  4. Study completion1 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
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.
Masking
None (open label)
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04829500
Sponsor's protocol ID
IIR 19-413
Acronym
MAP-VA
Status last verified
Feb 2025
First submitted
31 Mar 2021
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A de-identified, anonymized dataset will be created at the end of the study. The study team does not have access to a data repository infrastructure; therefore specific requests for use of the final data will be considered by contacting the local team.

Publications

  • 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.

    PubMed 39039035

  • Curyto K, Haigh SV, Mcintosh N, Kennedy KA, Mills WL, Bishop T, McConeghy KW, Hartmann CW, Hilgeman MM. Montessori approaches counterbalance pandemic precautions in nursing homes: staff perspectives. Gerontologist. 2026 Apr 13;66(5):gnag026. doi: 10.1093/geront/gnag026.

    PubMed 41849432

Questions about this trial

What is this clinical trial studying?

A study testing Montessori Approaches to Person-Centered Care (MAP-VA) in people with Dementia or a Related Disorder and Mental Health Diagnoses, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in resident agitation from pre-intervention to post-intervention (time frame: Primary data collection occurs at 4 time points across 7 months (2 pre-intervention and 2 after the intervention has been initiated)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04829500, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

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