Independent LivingNCT03634033
Implementation of CAPABLE in the Michigan Medicaid Waiver
A study testing MiCAP with IF (Main Study), MiCAP with IF and EF (Main Study) and MiCAP with IF and Caregiver Engagement (Administrative Supplement) in people with Independent Living, run by Grand Valley State University at 18 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Independent Living
- What is being tested?
- MiCAP with IF (Main Study), MiCAP with IF and EF (Main Study) and MiCAP with IF and Caregiver Engagement (Administrative Supplement)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,777 participants
- Where
- 18 sitesUnited States
- Study dates
- 6 Jun 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Northeast Michigan Community Service Agency (NEMCSA)
Alpena, Michigan, 49707
Region 3B Area Agency on Aging/CareWell Services Southwest
Battle Creek, Michigan, 49017
Region VII Area Agency on Aging
Bay City, Michigan, 48706
Region 2 Area Agency on Aging
Brooklyn, Michigan, 49230
Macomb-Oakland Regional Center Home Care, Inc.
Clinton Township, Michigan, 48038
Detroit Area Agency on Aging
Detroit, Michigan, 48207
UPCAP
Escanaba, Michigan, 49829
Valley Area Agency on Aging
Flint, Michigan, 48502
Area Agency on Aging of Western Michigan, Inc.
Grand Rapids, Michigan, 49525
Senior Services
Kalamazoo, Michigan, 49001
Tri-County Office on Aging
Lansing, Michigan, 48911
Senior Resources
Muskegon, Michigan, 49444
A&D Home Health Care, Inc.
Saginaw, Michigan, 48603
Region IV Area Agency on Aging
Saint Joseph, Michigan, 49085
The Information Center
Taylor, Michigan, 48180
Northern Lakes Community Mental Health/Northern Health Care Management
Traverse City, Michigan, 49684
Area Agency on Aging of Northwest Michigan
Traverse City, Michigan, 49696
The Senior Alliance
Wayne, Michigan, 48184
About this study
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
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.
Read the 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.
- Conditions
- Independent Living
- Being tested
- MiCAP with IF (Main Study), MiCAP with IF and EF (Main Study), MiCAP with IF and Caregiver Engagement (Administrative Supplement)
- Keywords
- Implementation Science, Adoption, Sustainability, Alzheimers Disease, Dementia, CAPABLE, Randomized Controlled Trial, Intervention, Feasibility, Acceptability
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiCAP with IF (Main Study)Behavioural
Also called CAPABLE
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)Behavioural
Also called CAPABLE
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MiCAP with IF (Main Study) | Experimental | MiCAP 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. Receives: Behavioral: MiCAP with IF (Main Study); Behavioral: MiCAP with IF and Caregiver Engagement (Administrative Supplement) |
| MiCAP with IF and EF (Main Study) | Experimental | MiCAP 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. Receives: Behavioral: MiCAP with IF (Main Study); Behavioral: MiCAP with IF and EF (Main Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (7)
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.
Measured: Exit (9-months)
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.
Measured: Exit (9-months)
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).
Measured: Exit (9-months)
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.
Measured: Exit (9-months)
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.
Measured: Exit (9-months)
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.
Measured: Exit (9-months)
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.
Measured: Exit (9-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start6 Jun 2019
- Primary completion15 Jun 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Independent LivingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Main Study: Randomized 2-Arms. Administrative Supplement: Cohort (Pilot) Study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,777 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grand Valley State University
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University, University of Oklahoma, National Institute on Aging (NIA), Michigan Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Sandra Spoelstra, PhD, Principal investigator, Grand Valley State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634033
- Sponsor's protocol ID
- 1R15AG058193-01
- Other IDs
- R15AG058193-01A1S1
- Status last verified
- Nov 2022
- First submitted
- 9 Aug 2018
- Last updated
- 30 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31196137Spoelstra 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.
PubMed 35585762Spoelstra 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.
PubMed 36028873
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03634033
- Acronym / sponsor ID
- 1R15AG058193-01
- Conditions
- Independent Living
- Keywords
- Implementation Science, Adoption, Sustainability, Alzheimers Disease, Dementia, CAPABLE, Randomized Controlled Trial, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,777 participants (actual)
- Lead sponsor
- Grand Valley State UniversityUniversity, hospital or other
- Collaborators
- Michigan State University, University of Oklahoma, National Institute on Aging (NIA), Michigan Department of Health and Human Services
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Main Study: Randomized 2-Arms. Administrative Supplement: Cohort (Pilot) Study.
| Arm | Type | Receives |
|---|---|---|
| MiCAP with IF (Main Study) | Experimental | Behavioral: MiCAP with IF (Main Study), Behavioral: MiCAP with IF and Caregiver Engagement (Administrative Supplement)MiCAP 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) | Experimental | Behavioral: MiCAP with IF (Main Study), Behavioral: MiCAP with IF and EF (Main Study)MiCAP 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiCAP with IF (Main Study)Also: CAPABLESites 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. | Behavioural | MiCAP with IF (Main Study), MiCAP with IF and EF (Main Study) |
| MiCAP with IF and EF (Main Study)Also: CAPABLESites 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. | Behavioural | MiCAP with IF and EF (Main Study) |
| 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. | Behavioural | MiCAP with IF (Main Study) |
Primary outcome
Main Study: Effect of MiCAP With IF Alone Versus MiCAP With IF+EF on Site-level Outcomes of Adoption and Sustainability of CAPABLE
Time frame: 9 months
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.
7 secondary outcomes
Main Study: Beneficiary's ADLs Summed Score
Time frame: Exit (9-months)
Main Study: Beneficiary's IADLs
Time frame: Exit (9-months)
Main Study: Beneficiary's Pain
Time frame: Exit (9-months)
Main Study: Beneficiary's Depression
Time frame: Exit (9-months)
Main Study: Beneficiary's Fall Rate
Time frame: Exit (9-months)
Main Study: Beneficiary's Emergency Department (ED) Visits Occurrences Out of Total Number of Participants.
Time frame: Exit (9-months)
Main Study: Beneficiary's Hospitalization Occurrences Out of Total Number of Participants.
Time frame: Exit (9-months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31196137Spoelstra 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.
- Results publication: PubMed 35585762Spoelstra 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.
- Derived from this study: PubMed 36028873Spoelstra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Spoelstra, PhD principal investigator
Grand Valley State University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiCAP with IF (Main Study), MiCAP with IF and EF (Main Study) and MiCAP with IF and Caregiver Engagement (Administrative Supplement) in people with Independent Living, run by Grand Valley State University at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Study: Effect of MiCAP With IF Alone Versus MiCAP With IF+EF on Site-level Outcomes of Adoption and Sustainability of CAPABLE (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634033, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.