Clinical trial NCT03634033: Implementation of CAPABLE in the Michigan Medicaid Waiver
Official title: Statewide Implementation of CAPABLE-Community Aging in Place, Advancing Better Living for Elders in the Michigan Medicaid Home and Community Based Waiver Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Independent Living
Keywords: Implementation Science
Adoption
Sustainability
Alzheimers Disease
Dementia
CAPABLE
Randomized Controlled Trial
Intervention
Feasibility
Acceptability
Lead sponsor: Grand Valley State University
Sponsor class: OTHER
Collaborators: name: Michigan State University
name: University of Oklahoma
name: National Institute on Aging (NIA)
name: Michigan Department of Health and Human Services
First posted: 2018-08-16
Enrollment: 7777
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Main Study: Randomized 2-Arms. Administrative Supplement: Cohort (Pilot) Study.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Main study: The National Institutes of Health (NIH) defines Implementation Science (IS) as the process of applying evidence to the treatment or prevention of human disease. In response, this trial is significant because it addresses testing of multimodal implementation strategies of an evidence-based intervention (CAPABLE) in a Medicaid setting to improve the quality and effectiveness of a waiver. Investigators will utilize implementation strategies refined in prior work (MiCAP; Hartford/Hillman/CMS) where the investigators trained clinicians (N=34) and provided CAPABLE for beneficiaries (N=270).

For this application, the investigators extend their work and train "all" Registered Nurses (RNs), Occupational Therapists (OTs), and Social Workers (SWs) (N=575) in the waiver sites in Michigan to implement the CAPABLE model of care for "all" Medicaid waiver beneficiaries (N=15,000). Guided by site managers, the team will select and train Internal Facilitators (IFs), who are supervisors/employees that work for the waiver site, to conduct facilitation at each site as "Champions". Investigators will utilize waiver employees as External Facilitators (EFs), who were early adopters of CAPABLE in prior work, as "Super-Champions" for Arm 2.

This trial is also significant as it addresses a critical barrier to implementation of evidence-based interventions to improve function in older adults living in the community to age-in-place (CAPABLE). Evidence suggest 90% of older adults prefer to age-in-place; yet a gap exists between their desire and ability. Thus, further testing of efficacy of an intervention (CAPABLE) in a Medicaid waiver population will fill a gap in science and build upon evidence.

The Institute of Medicine, NIH, and the Agency for Healthcare Research and Quality have each established IS as a research priority so that the benefits of evidence-based interventions can be realized. Consequently, strategies (MiCAP) to overcome barriers and increase the pace and the effectiveness of implementation are a public health priority. The multimodal implementation strategies (MiCAP N=6) include: assessing readiness, conducting training, using IF Champions, building an IF coalition, and audit and feedback is adequate. Additionally, investigators will examine if the additive EF is required to support adoption and sustainability of an evidence-based intervention (CAPABLE).

Disabilities in basic activities of daily living (ADLs \[e.g., bathing, toileting\]) and instrumental ADLs (IADL \[e.g., shopping, cleaning\]) are the primary modifiable predictors of nursing home (NH) placement. Disability is also a major driver of increased risk of falls and may lead to poor quality-of-life. Disability creates an inability to carry out everyday ADLs. There are a number of risks for disability like complex medication regimens, poor balance and strength, inadequate communication with clinicians, falling, and unsafe ADL performance. In addition, unsafe environments and deteriorated housing increase risk.

To address this problem, the evidence-based intervention, CAPABLE, addresses modifiable intrinsic and extrinsic risk factors and considers the psychological, environmental, and physical factors to enhance function of disabled individuals and promote aging-in-place. A multi-component model of care, CAPABLE was designed to reduce the effect of problems with physical function among low-income older adults living at home by addressing an individual's capabilities and the home environment.

CAPABLE was adapted from the ABLE program. ABLE used a person-directed, consultative model involving 6 home sessions conducted by OTs and physical therapists who provided home alterations (assistive devices \[e.g., shower chair, reacher, raised toilet seat\], environmental modifications \[e.g., grab bar, ramps\], and select home modifications \[e.g., widen bathroom doorway\]) and instruction in various techniques to enable participants to achieve self-identified functional goals. CAPABLE is a 16-week structured program delivered by OTs who conduct 6 home visits and provide assistive devices, RNs who conduct 4 home visits, and a repairperson who provides home alterations (i.e., installs devices, environmental modifications, and home repair). CAPABLE's interdisciplinary team provides consultation with older adults to help them identify daily activity goals (e.g., taking a shower, walking to the bathroom), evaluate barriers to achieving those goals, and attain outcomes collaboratively. The OT addresses ADLs, IADLs, and discretionary activities at home such as functional mobility, meal preparation, bathing, and dressing. The RN targets underlying issues that influence ADLs, IADLs, and discretionary activities at home, such as pain reduction, improvement in mood, fall prevention, medication review and management, primary care physician communication, incontinence management, sexual health, and smoking cessation. CAPABLE draws upon approaches to enhance uptake and adoption of strategies by patients by assessing readiness and using motivational interviewing.

In this trial, the investigators move IS forward by examining a multimodal implementation strategy (MiCAP) approach to implement evidence (CAPABLE) in a Medicaid Waiver program. To fill an IS gap, investigators will use proven implementation strategies that are packaged (MiCAP) and delivered to clinicians in the waiver program sites to support beneficiary improvement in function and those factors that influence function in older disabled adults aging-in-place.

ADMINISTRATIVE SUPPLEMENT There is a paucity of literature on caregiver provision of assessment or direct care to individuals with AD or dementia, as most discuss burden, confidence, stress, depression, or health. In 2005, the AARP used a Delphi technique to identify caregiver competency domains of medical/nursing skills, assessment, measurement, collaborating, and communication. A review of caregiver training programs found problem solving, use of community resources, and communication to be the primary focus. Physical or emotional assessment, medical/nursing skills training, home exercises, medication management, or planning, like what is needed when delivering CAPABLE, appeared to be lacking in caregiver training. Regarding toolkit usage, Powell and colleagues recommend using toolkits when implementing interventions, and our parent trial uses a beneficiary toolkit. A recent review of 72 studies evaluating use of toolkits (i.e. weight management, fall prevention, vaccination, pain management, and patient safety) found 57% reported adherence to clinical procedures and toolkit effects were positive. This finding supports use of a toolkit with caregivers when CAPABLE is deployed with beneficiaries with AD or dementia. Many older adults cared for by informal caregivers have unmet needs. A 44.3% (38.2% ADL related, 14.6% IADL related) unmet need rate is common among older adults with caregivers. Higher rates of unmet needs are likely in beneficiaries in the waiver as they are multi-morbid and low-income with few resources and even worse in those 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.

Primary outcomes:
measure: Main Study: Effect of MiCAP With IF Alone Versus MiCAP With IF+EF on Site-level Outcomes of Adoption and Sustainability of CAPABLE
timeFrame: 9 months
Secondary outcomes:
measure: Main Study: Beneficiary's ADLs Summed Score
timeFrame: Exit (9-months)
measure: Main Study: Beneficiary's IADLs
timeFrame: Exit (9-months)
measure: Main Study: Beneficiary's Pain
timeFrame: Exit (9-months)
measure: Main Study: Beneficiary's Depression
timeFrame: Exit (9-months)
measure: Main Study: Beneficiary's Fall Rate
timeFrame: Exit (9-months)
measure: Main Study: Beneficiary's Emergency Department (ED) Visits Occurrences Out of Total Number of Participants.
timeFrame: Exit (9-months)
measure: Main Study: Beneficiary's Hospitalization Occurrences Out of Total Number of Participants.
timeFrame: Exit (9-months)
Other outcomes:
measure: Main Study: Clinician Attitude Towards Evidence Based Practice Use
timeFrame: Exit (9-months)
measure: Main Study: Clinician Self-efficacy
timeFrame: Exit (9-months)
measure: Administrative Supplement: Feasibility of Use of Intervention With Clinicians, Caregivers and Beneficiaries.
timeFrame: Recruitment period of 9-months.
measure: Administrative Supplement: Acceptability of Caregiver Use of Intervention With Beneficiaries.
timeFrame: 9-months
measure: Administrative Supplement: Beneficiaries Outcomes Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADLs), Pain and Depression) Pre-/Post-intervention From Minimum Data Set-Home Care MDS-HC.
timeFrame: Baseline (0-months) compared to Exit (9-months)
measure: Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention.
timeFrame: Self-efficacy: baseline (month-0) and Exit (month-4). Satisfaction: Monthly for month 0 (baseline), 1, 2, 3, 4 (exit)
measure: Administrative Supplement: Clinician Satisfaction With Training and Use of Intervention.
timeFrame: 9-months
Locations:
city: Alpena
country: United States
facility: Northeast Michigan Community Service Agency (NEMCSA)
state: Michigan
city: Battle Creek
country: United States
facility: Region 3B Area Agency on Aging/CareWell Services Southwest
state: Michigan
city: Bay City
country: United States
facility: Region VII Area Agency on Aging
state: Michigan
city: Brooklyn
country: United States
facility: Region 2 Area Agency on Aging
state: Michigan
city: Clinton Township
country: United States
facility: Macomb-Oakland Regional Center Home Care, Inc.
state: Michigan
city: Detroit
country: United States
facility: Detroit Area Agency on Aging
state: Michigan
city: Escanaba
country: United States
facility: UPCAP
state: Michigan
city: Flint
country: United States
facility: Valley Area Agency on Aging
state: Michigan
city: Grand Rapids
country: United States
facility: Area Agency on Aging of Western Michigan, Inc.
state: Michigan
city: Kalamazoo
country: United States
facility: Senior Services
state: Michigan
city: Lansing
country: United States
facility: Tri-County Office on Aging
state: Michigan
city: Muskegon
country: United States
facility: Senior Resources
state: Michigan
city: Saginaw
country: United States
facility: A&D Home Health Care, Inc.
state: Michigan
city: Saint Joseph
country: United States
facility: Region IV Area Agency on Aging
state: Michigan
city: Taylor
country: United States
facility: The Information Center
state: Michigan
city: Traverse City
country: United States
facility: Northern Lakes Community Mental Health/Northern Health Care Management
state: Michigan
city: Traverse City
country: United States
facility: Area Agency on Aging of Northwest Michigan
state: Michigan
city: Wayne
country: United States
facility: The Senior Alliance
state: Michigan
Study officials:
affiliation: Grand Valley State University
name: Sandra Spoelstra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Spoelstra 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.
citation: Spoelstra 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.