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Implementation of CAPABLE in the Michigan Medicaid Waiver

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ClinicalTrials.gov Identifier: NCT03634033
Recruitment Status : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Grand Valley State University

Brief Summary:
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 Community Aging in Place, Advancing Better Living for Elders (CAPABLE), 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 entitled "MiCAP". This R15 application will test site-level adoption and sustainability of CAPABLE after deploying the MiCAP package of implementation strategies (readiness assessment, training, facilitation, champions, coalition building, and audit and feedback). The real world setting is 18 Medicaid Home and Community Based Service "waiver" program sites in Michigan that care for community dwelling disabled older adults. Baseline measures of characteristics, leadership and readiness (site), and attitude and efficacy (clinicians) will be obtained. Investigators will train facilitators (Champions) at each site who will train an interdisciplinary team of nurses, occupational therapists, and social workers who will then provide CAPABLE. A facilitator coalition will be formed to share best implementation practices. The Stages-of-Implementation tool will be used to assess success. Sites will be randomized to internal facilitation alone or internal facilitation plus external facilitation. Post-intervention data from waiver sites and clinicians will be collected. Medicaid beneficiary-level outcomes will be examined (activities of daily living, instrumental activities of daily living, pain, depression, falls, emergency room and hospital use) over 9-months to report on intervention efficacy in this population. 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. This natural setting approach has high generalizability for waivers, as the investigators learn what intensity of implementation strategies are needed to adopt evidence in a waiver. The investigators will engage students as members of the team and building the College of Nursing's research capacity.

Condition or disease Intervention/treatment Phase
Independent Living Behavioral: MiCAP with IF Behavioral: MiCAP with IF and EF Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 575 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adoption Medicaid

Arm Intervention/treatment
Experimental: MiCAP with IF
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.
Behavioral: MiCAP with IF
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

Experimental: MiCAP with IF and EF
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.
Behavioral: MiCAP with IF
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

Behavioral: MiCAP with IF and EF
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.




Primary Outcome Measures :
  1. Change of effects of MiCAP with IF alone versus MiCAP with IF+EF on site-level outcomes of adoption and sustainability of CAPABLE [ Time Frame: 6 and 9 months ]
    The Stages of Implementation Completion is an 8-stage tool of implementation process and milestones, with stages spanning 3 phases. Three scores are derived: 1) number of stages completed; 2) time spent in each stage; and 3) proportion of activities completed in each stage. Number of stages completed is a count of progression through stages; the score is the last stage in which at least one activity was performed. Time spent in each stage is calculated by taking the difference between the date of completion of the first activity and the date of completion of the last activity in the same stage. Complete all 8 stages: the final completion date is logged in stage 8. For sites that chose to discontinue implementation, the date is logged in the furthest stage that the site enters. Proportion of activities completed is calculated as number of activities completed divided by number of possible activities in each stage.


Secondary Outcome Measures :
  1. Change of effects of MiCAP with IF alone versus MiCAP with IF+EF on beneficiary-level outcomes [ Time Frame: 6 and 9 months ]
    Beneficiary-level outcomes include ADL/IADLs, pain, depression, falls, emergency department (ED) visits and hospitalizations. Beneficiary outcomes will be 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.


Other Outcome Measures:
  1. Change of effects of EF+IF versus IF on primary outcomes are mediated by clinician attitude [ Time Frame: 6 and 9 months ]
    Evidence-Based Practice Attitude Scale (EBPAS-50) is a 50-item tool that assesses mental health and social service providers' attitudes toward adopting EBP. The EBPAS-50 covers 12 subscales: appeal, requirements, openness, divergence, limitations, fit, monitoring, balance, burden, job security, organizational support, and feedback. The 12 subdomains sum up in a higher order total scale score representing respondent's global attitudes toward EBP. Responses are given on a 5-point Likert scale ranging from 0-"not at all" to 4-"to a very great extent". In order to assess different perspectives and to reduce response biases, 23 items belonging to five subscales (divergence, limitations, monitoring, balance, and burden) are negatively framed. For the total score these items are reversed scored, and the mean subscale scores 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 EBP.

  2. Change of effects of EF+IF versus IF on primary outcomes are mediated by clinician self-efficacy [ Time Frame: 6 and 9 months ]
    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.

  3. Benchmark the change of effects of IF and EF+IF on beneficiary outcomes following implementation as compared to pre-intervention [ Time Frame: Pre-intervention, 6 months, 9 months ]
    Beneficiary outcomes are defined above and will be collected as described above. The pre-intervention data will be collected by using the MDS-HC completed prior to the onset of the intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 Center for Information Management (CIM) electronic health record

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Responsible Party: Grand Valley State University
ClinicalTrials.gov Identifier: NCT03634033     History of Changes
Other Study ID Numbers: 1R15AG058193-01 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Grand Valley State University:
Implementation Science
Adoption
Sustainability