N/A
N=7,777
Implementation of CAPABLE in the Michigan Medicaid Waiver
Independent Living
Bottom Line
View on ClinicalTrials.gov: NCT03634033 ↗Enrolled (actual)
7,777
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Main Study: Effect of MiCAP With IF Alone Versus MiCAP With IF+EF on Site-level Outcomes of Adoption and Sustainability of CAPABLE — 72.22; 61.33 score on a scale — p=0.22
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MiCAP with IF (Main Study) (Behavioral); MiCAP with IF and EF (Main Study) (Behavioral); MiCAP with IF and Caregiver Engagement (Administrative Supplement) (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Grand Valley State University
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Study: Effect of MiCAP With IF Alone Versus MiCAP With IF+EF on Site-level Outcomes of Adoption and Sustainability of CAPABLE |
72.22; 61.33 | 0.22 |
| SECONDARY Main Study: Beneficiary's ADLs Summed Score |
26.13; 25.85 | 0.73 |
| SECONDARY Main Study: Beneficiary's IADLs |
29.54; 29.24 | 0.15 |
| SECONDARY Main Study: Beneficiary's Pain |
7.52; 7.44 | 0.61 |
| SECONDARY Main Study: Beneficiary's Depression |
1.3; 1.17 | 0.04 sig |
| SECONDARY Main Study: Beneficiary's Fall Rate |
0.15; 0.14 | 0.18 |
| SECONDARY Main Study: Beneficiary's Emergency Department (ED) Visits Occurrences Out of Total Number of Participants. |
0.92; 0.91 | 0.86 |
| SECONDARY Main Study: Beneficiary's Hospitalization Occurrences Out of Total Number of Participants. |
0.01; .01 | 0.95 |
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.
Eligibility Criteria
MAIN TRIAL:
Inclusion Criteria: Waiver program site must be under contract as a Home and Community Based Services (HCBS) waiver provider in Michigan (including clinicians and beneficiaries). Waiver program site must use the Center for Information Management (CIM) electronic health record.
Exclusion Criteria: Waiver program site not under contract as a HCBS waiver provider in Michigan. Waiver program site not using the single electronic health record from Center for Information Management (CIM).
ADMINISTRATIVE SUPPLEMENT (all in main trial plus below):
Inclusion Criteria: Caregivers designated in beneficiary's record, and beneficiary diagnosed with Alzheimer's Disease or dementia.
Exclusion Criteria: Without a caregiver or beneficiary not diagnosed with Alzheimer's Disease or dementia.
Data sourced from ClinicalTrials.gov (NCT03634033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.