Implementation of CAPABLE in the Michigan Medicaid Waiver
Statewide Implementation of CAPABLE-Community Aging in Place, Advancing Better Living for Elders in the Michigan Medicaid Home and Community Based Waiver Program
2 other identifiers
interventional
7,777
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Typical duration for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 16, 2018
CompletedStudy Start
First participant enrolled
June 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedResults Posted
Study results publicly available
November 30, 2022
CompletedNovember 30, 2022
November 1, 2022
2 years
August 9, 2018
May 26, 2022
November 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Main Study: Effect of MiCAP With IF Alone Versus MiCAP With IF+EF on Site-level Outcomes of Adoption and Sustainability of CAPABLE
Adoptions and sustainability of the intervention using the Stages of Implementation Completion (SIC) at a site (18). SIC is a tool that tracks achievement of key activities when implementing an evidence-based intervention. SIC has 6 stages with multiple implementation activities; each activity had an assigned numeric value and when a activity was completed, a score was assigned. The \*total\* SIC score ranges from 0-100. Stage 1 score range 0-12. Stage 2 0-16. Stage 3 0-24. Stage 4 0-16. Stage 5 0-16. Stage 6 0-16. The \*total\* score was calculated by summing the points of each stage. The higher the \*total\* score, the more implementation activities were completed. For the below reported \*total\* score, each waiver site had their \*total\* SIC score numerically calculated. Then, the mean and standard deviation were calculated by group/arm.
9 months
Secondary Outcomes (7)
Main Study: Beneficiary's ADLs Summed Score
Exit (9-months)
Main Study: Beneficiary's IADLs
Exit (9-months)
Main Study: Beneficiary's Pain
Exit (9-months)
Main Study: Beneficiary's Depression
Exit (9-months)
Main Study: Beneficiary's Fall Rate
Exit (9-months)
- +2 more secondary outcomes
Other Outcomes (7)
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Exit (9-months)
Main Study: Clinician Self-efficacy
Exit (9-months)
Administrative Supplement: Feasibility of Use of Intervention With Clinicians, Caregivers and Beneficiaries.
Recruitment period of 9-months.
- +4 more other outcomes
Study Arms (2)
MiCAP with IF (Main Study)
EXPERIMENTALMiCAP with Internal Facilitation will receive MiCAP (implementation strategies). Internal facilitators will be waiver site clinicians with exemplary clinical practice and/or supervisory experience, who are expected to be early adopters of CAPABLE; and will be selected by their supervisors.
MiCAP with IF and EF (Main Study)
EXPERIMENTALMiCAP with Internal Facilitation and External Facilitation will receive MiCAP (implementation strategies) and the addition of external facilitation. The external facilitators will be Super-Champion waiver program site clinicians from prior work who were trained and early adopters of CAPABLE; and will be selected by the research team to perform external facilitation.
Interventions
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.
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.
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.
Eligibility Criteria
You may not qualify if:
- ADMINISTRATIVE SUPPLEMENT (all in main trial plus below):
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grand Valley State Universitylead
- Michigan State Universitycollaborator
- University of Oklahomacollaborator
- National Institute on Aging (NIA)collaborator
- Michigan Department of Health and Human Servicescollaborator
Study Sites (18)
Northeast Michigan Community Service Agency (NEMCSA)
Alpena, Michigan, 49707, United States
Region 3B Area Agency on Aging/CareWell Services Southwest
Battle Creek, Michigan, 49017, United States
Region VII Area Agency on Aging
Bay City, Michigan, 48706, United States
Region 2 Area Agency on Aging
Brooklyn, Michigan, 49230, United States
Macomb-Oakland Regional Center Home Care, Inc.
Clinton Township, Michigan, 48038, United States
Detroit Area Agency on Aging
Detroit, Michigan, 48207, United States
UPCAP
Escanaba, Michigan, 49829, United States
Valley Area Agency on Aging
Flint, Michigan, 48502, United States
Area Agency on Aging of Western Michigan, Inc.
Grand Rapids, Michigan, 49525, United States
Senior Services
Kalamazoo, Michigan, 49001, United States
Tri-County Office on Aging
Lansing, Michigan, 48911, United States
Senior Resources
Muskegon, Michigan, 49444, United States
A&D Home Health Care, Inc.
Saginaw, Michigan, 48603, United States
Region IV Area Agency on Aging
Saint Joseph, Michigan, 49085, United States
The Information Center
Taylor, Michigan, 48180, United States
Northern Lakes Community Mental Health/Northern Health Care Management
Traverse City, Michigan, 49684, United States
Area Agency on Aging of Northwest Michigan
Traverse City, Michigan, 49696, United States
The Senior Alliance
Wayne, Michigan, 48184, United States
Related Publications (3)
Spoelstra SL, Schueller M, Sikorskii A. Testing an implementation strategy bundle on adoption and sustainability of evidence to optimize physical function in community-dwelling disabled and older adults in a Medicaid waiver: a multi-site pragmatic hybrid type III protocol. Implement Sci. 2019 Jun 13;14(1):60. doi: 10.1186/s13012-019-0907-1.
PMID: 31196137BACKGROUNDSpoelstra SL, Schueller M, Dorn E, Sikorskii A. Measuring Organizational Readiness for Change in Michigan's Home and Community-based Services Program: Instrument Adaptation and Psychometric Testing. Home Health Care Serv Q. 2022 Jul-Sep;41(3):255-266. doi: 10.1080/01621424.2022.2077161. Epub 2022 May 18.
PMID: 35585762RESULTSpoelstra SL, Schueller M, Basso V, Sikorskii A. Results of a multi-site pragmatic hybrid type 3 cluster randomized trial comparing level of facilitation while implementing an intervention in community-dwelling disabled and older adults in a Medicaid waiver. Implement Sci. 2022 Aug 26;17(1):57. doi: 10.1186/s13012-022-01232-5.
PMID: 36028873DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Main Study: we were unable to collect data on fidelity to intervention (CAPABLE) use in the electronic health record during the trial as COVID Pandemic minimal documentation standards were in effect due to short staffing which limited data entry by clinicians.
Results Point of Contact
- Title
- Dr. Sandra Spoelstra
- Organization
- Grand Valley State University
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra Spoelstra, PhD
Grand Valley State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 16, 2018
Study Start
June 6, 2019
Primary Completion
June 15, 2021
Study Completion
June 30, 2022
Last Updated
November 30, 2022
Results First Posted
November 30, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share