Implementation of CAPABLE in the Michigan Medicaid Waiver

NCT03634033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7777

Last updated 2022-11-30

Study results available
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Summary

Main study: Nearly half of older adults report problems with function, which can lead to difficulty with activities of daily living and nursing home placement. Thus, there is a need to implement evidence-based models of care to improve function and those factors that support function in older adults living in the community. One such model is CAPABLE (Community Aging in Place Advancing Better Living for Elders), a person-centered, nurse and occupational therapy intervention supported by assistive devices and home modifications. The investigators build on prior work that translated CAPABLE and conducted preliminary testing of a package of implementation strategies. This R15 application will test site-level adoption and sustainability after deploying a package of implementation strategies (readiness assessment, training, facilitation, champions, coalition building, and audit and feedback). Sites will be randomized to internal facilitation alone or internal facilitation plus external facilitation. This work will impact implementation science by testing two approaches to implementation of an evidence-based intervention to improve outcomes among older adults in a Medicaid Waiver program.

ADMINISTRATIVE SUPPLEMENT We extend the Parent Trial by addressing a problem found while deploying CAPABLE with beneficiaries with Alzheimer's disease (AD) or dementia. There are 39.8 million informal caregivers in the US and 16.3 million who care for someone with AD or dementia; and 1,500 of those are in the Michigan waiver. Most beneficiaries with those conditions did not accept CAPABLE as they were unable to receive instruction. Interventions that improve caregiver knowledge, confidence, and self-efficacy improve care they provide. Thus, the goal is to extend provision of CAPABLE to beneficiaries with AD or dementia via the engagement of their informal caregivers. This work is significant as there are 1,500 beneficiaries with AD or dementia in the waiver who could benefit from CAPABLE yet many did not, as they were to receive instructions. To date, CAPABLE has only been designed to be used directly with the individuals without caregiver involvement. In the waiver, beneficiaries are required to have a designated caregiver, therefore, modifying the toolkit for use by caregivers could aid in deploying CAPABLE to beneficiaries with AD or dementia.

Conditions

  • Independent Living

Interventions

BEHAVIORAL

MiCAP with IF (Main Study)

Sites will conduct MiCAP strategies described as follows. Relationship Building; Assess readiness to implement of the site; Internal Facilitator (IF) Champion Coalition Building, which will include IFs training in CAPABLE and facilitation and online IF coalition meetings; Facilitation by the IF, which will include training the clinicians, reviewing home visits with the clinician to assure CAPABLE was provided; IF developing a clinical team for implementation of CAPABLE and leading interdisciplinary coordination of individual beneficiary care; Intervention and implementation strategy fidelity data will be placed in a dashboard for audit and provided to IFs. IFs will use the data to provide feedback to clinicians; and develop action plans for improvement in training or care. CAPABLE is a multi-component intervention used to enhance older adults ability to function at home independently.

BEHAVIORAL

MiCAP with IF and EF (Main Study)

Sites will conduct MiCAP strategies described above in "MiCAP with IF" with an addition of External Facilitation. Centralized Oversight will be conducted by External Facilitators. External Facilitators will train in facilitation. The work of the External Facilitators will be tailored (i.e., type of discipline) to each site's needs. Intervention and implementation strategy fidelity data will be placed in a dashboard and will be provided to External Facilitators. External Facilitators will use the data to provide feedback to Internal Facilitators; and develop action plans for improvement in site clinician training or beneficiary care as needed. CAPABLE is a multi-component intervention used to enhance older adults ability to function at home independently.

BEHAVIORAL

MiCAP with IF and Caregiver Engagement (Administrative Supplement)

A pilot study to examine use of informal caregiver engagement to provide CAPABLE to beneficiaries with Alzheimer's Disease or other Dementia using MiCAP with Internal Facilitation (implementation strategies from the (Main Study). External facilitator will be Champion, clinician, and an early adopters of CAPABLE.

Sponsors & Collaborators

  • Michigan State University

    collaborator OTHER
  • University of Oklahoma

    collaborator OTHER
  • National Institute on Aging (NIA)

    collaborator NIH
  • Michigan Department of Health and Human Services

    collaborator OTHER
  • Grand Valley State University

    lead OTHER

Principal Investigators

  • Sandra Spoelstra, PhD · Grand Valley State University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2021-06-15
Completion
2022-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03634033 on ClinicalTrials.gov