Implementation of CAPABLE in the Michigan Medicaid Waiver

Independent Living Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634033
• Other study ID #: 1R15AG058193-01
• Secondary ID: R15AG058193-01A1
• Status: Completed
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: Grand Valley State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7777
• Est. completion date: June 30, 2022
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Independent Living

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Northeast Michigan Community Service Agency (NEMCSA)	Alpena	Michigan
United States	Region 3B Area Agency on Aging/CareWell Services Southwest	Battle Creek	Michigan
United States	Region VII Area Agency on Aging	Bay City	Michigan
United States	Region 2 Area Agency on Aging	Brooklyn	Michigan
United States	Macomb-Oakland Regional Center Home Care, Inc.	Clinton Township	Michigan
United States	Detroit Area Agency on Aging	Detroit	Michigan
United States	UPCAP	Escanaba	Michigan
United States	Valley Area Agency on Aging	Flint	Michigan
United States	Area Agency on Aging of Western Michigan, Inc.	Grand Rapids	Michigan
United States	Senior Services	Kalamazoo	Michigan
United States	Tri-County Office on Aging	Lansing	Michigan
United States	Senior Resources	Muskegon	Michigan
United States	A&D Home Health Care, Inc.	Saginaw	Michigan
United States	Region IV Area Agency on Aging	Saint Joseph	Michigan
United States	The Information Center	Taylor	Michigan
United States	Area Agency on Aging of Northwest Michigan	Traverse City	Michigan
United States	Northern Lakes Community Mental Health/Northern Health Care Management	Traverse City	Michigan
United States	The Senior Alliance	Wayne	Michigan

Sponsors (5)

Lead Sponsor	Collaborator
Grand Valley State University	Michigan Department of Health and Human Services, Michigan State University, National Institute on Aging (NIA), University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Main Study: Clinician Attitude Towards Evidence Based Practice Use	Evidence-Based Practice Attitude Scale (EBPAS-50) is a 50-item tool that assesses clinician attitudes toward adopting evidence into practice. EBPAS-50 has 50 items on the tool which includes 10 sub-scales: limitations, openness, monitoring, requirements, employability, feedback, burden, appeal, divergence, balance; and the questions are negatively framed. The 10 sub-scales are summed into a higher order total scale score representing respondent's attitude toward adopting evidence into practice.; EBPAS-50 total scale score ranges from 0-200 with higher being a better attitude towards use of evidence in practice. Each of the 10 sub-scales ranges from 0-20; with higher being a better attitude towards use of evidence.; Items are reversed scored, and the mean sub-scale scores are recomputed, before a mean score for the total EBPAS-50 item score is computed.; A higher total score indicate a more positive attitude towards adoption of evidence-based practice use.	Exit (9-months)
Other	Main Study: Clinician Self-efficacy	General Self-efficacy (GSE) is a 10-item tool (Cronbach .79-.90) with a 4-point scale summed to 10-40, with a higher score indicating more self-efficacy.	Exit (9-months)
Other	Administrative Supplement: Feasibility of Use of Intervention With Clinicians, Caregivers and Beneficiaries.	Feasibility of use of intervention with caregivers use of toolkit with beneficiaries with Alzheimer's Disease or dementia following implementation of CAPABLE.; Feasibility was measured as: the percentage of those who consented and enrolled of those who were recruited who were eligible.	Recruitment period of 9-months.
Other	Administrative Supplement: Acceptability of Caregiver Use of Intervention With Beneficiaries.	Acceptability of Caregiver Use of Toolkit With Beneficiaries With Alzheimer's Disease or Dementia Following Implementation of CAPABLE. Acceptability: counts of toolkit use and sections used.	9-months
Other	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.	Activities of Daily Living: 11 items each rated as 0=Independent, 1=Set-up help, 2=Supervision, 3=Limited assist, 4=Extensive assist, 5=Maximal assist, 6=Total dependence; summed score ranged 0-66; higher score=worse Activities of Daily Living; Instrumental Activities of Daily Living: 8 items each rated as 0=Independent, 1=Set-up help, 2=Supervision, 3=Limited assist, 4 Extensive assist, 5=Maximal assist, 6=Total dependence; summed score ranged 0-48; higher score=worse Instrumental Activities of Daily Living; Pain: 4 items; ranges for frequency 0-3, intensity 0-4, consistency 0-3, breakthrough 0-1; summed score ranged 0-11; lower score=less pain.; Depression: 3 items little interest in things; anxious, restless, or uneasy; and sad, depressed, or hopeless; scored as 0=Not in last 3 days, 1=Not in last 3 days, but often feels that way, 2=In 1-2 days of last 3 days, 3=Daily in last 3 days, 8=Person could/would not respond; summed score ranged 0-24; lower score=less depressed	Baseline (0-months) compared to Exit (9-months)
Other	Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention.	Self-efficacy and satisfaction of Caregiver Use of intervention With Beneficiaries With Alzheimer's Disease or Dementia Following Implementation of CAPABLE. Efficacy effect size of intervention use on beneficiary outcomes from Parent Trial.; SELF-EFFICACY TOOL: General Self-efficacy (GSE) is a 10-item tool (Cronbach .79-.90) with a 4-point scale summed to 0-40, with a higher score indicating more or higher self-efficacy. Cronbach's alpha at baseline was .91 for the caregiver GSE.; SATISFACTION TOOL: Developed by PI and Team. There were 3-items measured on a scale of 1 to 10 (reported as individual concepts; not summed), with 10 being the highest satisfaction. Question 1 Content: How satisfied were you with the Toolkit content? (range 1-10). Question 2 Format: How satisfied were you with the format of the Toolkit? (range 1-10). Question 3 Helpfulness: How helpful was the Toolkit? (range 1-10)".	Self-efficacy: baseline (month-0) and Exit (month-4). Satisfaction: Monthly for month 0 (baseline), 1, 2, 3, 4 (exit)
Other	Administrative Supplement: Clinician Satisfaction With Training and Use of Intervention.	Clinician satisfaction with training and use of caregiver to assist with intervention. Satisfaction: was measured using a Likert scored tool evaluating level of satisfaction (scale 1-10 with 1 being poorest).	9-months
Primary	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	Main Study: Beneficiary's ADLs Summed Score	Activities of Daily Living (ADLs) data were collected from the Minimum Data Set-Home Care (MDS-HC) in the Electronic Health Record (EHR). MDS-HC is a person-centered assessment for the collection of minimum essential nursing data, with reliability and validity, and used in the Michigan Medicaid Waiver program.; The score is a summed score of 11 items on the MDS-HC; with a score range of 0-88. The lower the summed score, the more independent the beneficiary is at performing ADLs. For the 11 items, the available scores are 0= Independent, 1= Set-up help only, 2= Supervision, 3= Limited assistance, 4= Extensive assistance, 5= Maximal assistance, 6= Total dependence, 8= Activity did not occur during entire period.	Exit (9-months)
Secondary	Main Study: Beneficiary's IADLs	Instrumental Activities of Daily Living (IADLs) was collected from the Minimum Data Set-Home Care (MDS-HC) in the Electronic Health Record (EHR). MDS-HC is a person-centered assessment for the collection of minimum essential nursing data, with reliability and validity, and used in the Michigan Medicaid Waiver program.; The below reported score is a summed score of 8 items on the MDS-HC; summed score range is 0-64. The lower the summed score, the more independent the beneficiary is at performing IADLs. For the 8 items, the available scores are 0= Independent, 1= Set-up help only, 2= Supervision, 3= Limited assistance, 4= Extensive assistance, 5= Maximal assistance, 6= Total dependence, 8= Activity did not occur during entire period.	Exit (9-months)
Secondary	Main Study: Beneficiary's Pain	Pain data were collected from the Minimum Data Set-Home Care (MDS-HC) in the Electronic Health Record (EHR). MDS-HC is a person-centered assessment for the collection of minimum essential nursing data, with reliability and validity, and used in the Michigan Medicaid Waiver program.; The score is a summed score of 4 self-reported items on the MDS-HC; the summed score range is 0-11. The lower the summed score, the less pain the beneficiary reported. The four items included: pain frequency (range 0-3); pain intensity (0-4); pain consistency (0-3); and breakthrough pain (0-1).	Exit (9-months)
Secondary	Main Study: Beneficiary's Depression	Depression was collected from the Minimum Data Set-Home Care (MDS-HC) in the Electronic Health Record (EHR). MDS-HC is a person-centered assessment for the collection of minimum essential nursing data, with reliability and validity, and used in the Michigan Medicaid Waiver program.; The below reported score is a summed score of 3 self-reported items on the MDS-HC; the summed score range is 0-24. The lower the summed score, the less depressed the beneficiary reported. The 3 items included: little interest in things; anxious, restless, or uneasy; and sad, depressed, or hopeless. For the 3 items, the available scores are 0= Not in last 3 days, 1= Not in last 3 days, but often feels that way, 2= In 1-2 days of last 3 days, 3= Daily in last 3 days, 8= Person could not (would not) respond.	Exit (9-months)
Secondary	Main Study: Beneficiary's Fall Rate	Beneficiary falls data were collected from the Minimum Data Set-Home Care (MDS-HC) in the Electronic Health Record. MDS-HC is a person-centered assessment for the collection of minimum essential nursing data, with reliability and validity, and used in the Michigan Medicaid Waiver program.; Falls were reported as proportions of occurrences on the MDS-HC; and calculated for this study based on the occurrence of a fall where yes=1 and no=0 divided by the number of participants.	Exit (9-months)
Secondary	Main Study: Beneficiary's Emergency Department (ED) Visits Occurrences Out of Total Number of Participants.	Beneficiary-level outcome emergency department (ED) data were collected from the Minimum Data Set-Home Care (MDS-HC) in the Electronic Health Record. MDS-HC is a person-centered assessment for the collection of minimum essential nursing data, with reliability and validity, and used in the Michigan Medicaid Waiver program.; ED visits were reported as proportion calculated based on the occurrence of an ED visit where yes=1 and no=0 out of the number of participants.	Exit (9-months)
Secondary	Main Study: Beneficiary's Hospitalization Occurrences Out of Total Number of Participants.	Beneficiary-level outcomes hospitalizations data were collected from the Minimum Data Set-Home Care (MDS-HC) in the Electronic Health Record. MDS-HC is a person-centered assessment for the collection of minimum essential nursing data, with reliability and validity, and used in the Michigan Medicaid Waiver program.; Hospitalizations were reported based on the occurrence and calculated for this study as rates of hospitalization where yes=1 and no=0 out of total number of participants.	Exit (9-months)