Independent Living
Conditions
Keywords
Implementation Science, Adoption, Sustainability, Alzheimers Disease, Dementia, CAPABLE, Randomized Controlled Trial, Intervention, Feasibility, Acceptability
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.
Interventions
BEHAVIORALMiCAP 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.
BEHAVIORALMiCAP 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.
BEHAVIORALMiCAP 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.
Sponsors
Michigan State University
University of Oklahoma
National Institute on Aging (NIA)
Michigan Department of Health and Human Services
Grand Valley State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Main Study: Randomized 2-Arms. Administrative Supplement: Cohort (Pilot) Study.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main Study: Effect of MiCAP With IF Alone Versus MiCAP With IF+EF on Site-level Outcomes of Adoption and Sustainability of CAPABLE | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Main Study: Beneficiary's ADLs Summed Score | Exit (9-months) | 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. |
| Main Study: Beneficiary's IADLs | Exit (9-months) | 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. |
| Main Study: Beneficiary's Pain | Exit (9-months) | 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). |
| Main Study: Beneficiary's Depression | Exit (9-months) | 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. |
| Main Study: Beneficiary's Fall Rate | Exit (9-months) | 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. |
| Main Study: Beneficiary's Emergency Department (ED) Visits Occurrences Out of Total Number of Participants. | Exit (9-months) | 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. |
| Main Study: Beneficiary's Hospitalization Occurrences Out of Total Number of Participants. | Exit (9-months) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Main Study: Clinician Self-efficacy | Exit (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. |
| Administrative Supplement: Feasibility of Use of Intervention With Clinicians, Caregivers and Beneficiaries. | Recruitment period of 9-months. | 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. |
| Administrative Supplement: Acceptability of Caregiver Use of Intervention With Beneficiaries. | 9-months | 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. |
| 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. | Baseline (0-months) compared to Exit (9-months) | 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 |
| Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Self-efficacy: baseline (month-0) and Exit (month-4). Satisfaction: Monthly for month 0 (baseline), 1, 2, 3, 4 (exit) | 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). |
| Administrative Supplement: Clinician Satisfaction With Training and Use of Intervention. | 9-months | 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). |
| Main Study: Clinician Attitude Towards Evidence Based Practice Use | Exit (9-months) | 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. |
Countries
United States
Participant flow
Recruitment details
MAIN STUDY. Group allocation-randomized 18 waiver sites, 9 to MiCAP with IF; and 9 to MiCAP with IF and EF. Recruited 2 groups of participants at each site: clinicians employed by the sites to provide the intervention to waiver beneficiaries to receive the intervention. ADMINISTRATIVE SUPP. No group allocation: Recruited 3 groups of participants at 3 sites from Main Study; clinicians employed at sites, caregivers to provide the intervention, and beneficiaries to receive it; plus MiCAP IF.
Pre-assignment details
COUNT OF PARTICIPANTS: for ARMS/GROUPS- Some clinicians/beneficiaries in MiCAP with IF Main Study may be represented in Administrative Supplement: clinicians/beneficiaries; counted more than once/signed more than 1 Consent Form. MAIN STUDY: UNITS- MiCAP with IF/IF+EF Beneficiaries and Clinicians use the same 18 sites. ADMINISTRATIVE SUPPLEMENT: Some caregivers dropped out of study after beneficiary passed away or transferred to a facility; the caregiver was not deceased or in a facility.
Participants by arm
| Arm | Count |
|---|---|
| Main Study: MiCAP With IF (Beneficiaries) 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: 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 | 3,497 |
| Main Study: MiCAP With IF+EF (Beneficiaries) 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.
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. | 3,533 |
| Main Study: MiCAP With IF (Clinicians) 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: 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 | 282 |
| Main Study: MiCAP With IF+EF (Clinicians) 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.
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. | 257 |
| Administrative Supplement: Clinicians Clinicians who were employed at the waiver sites and were trained in using the toolkit when implementing CAPABLE with caregivers of beneficiaries with Alzheimer's Disease or Dementia. | 106 |
| Administrative Supplement: Caregivers Caregivers of beneficiaries diagnosed with Alzheimer's Disease or Dementia who will receive the toolkit to assist in taking care of their beneficiary. | 50 |
| Administrative Supplement: Beneficiaries Beneficiaries enrolled at the waiver who were diagnosed with Alzheimer's Disease or Dementia. | 52 |
| Total | 7,777 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 7 | 7 |
| Overall Study | Did not have a post-assessment | 384 | 291 | 114 | 161 | 5 | 0 | 0 |
| Overall Study | In Assisted Living/Nursing Home/Hospice | 0 | 0 | 0 | 0 | 0 | 5 | 5 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Main Study: MiCAP With IF (Beneficiaries) | Main Study: MiCAP With IF+EF (Beneficiaries) | Main Study: MiCAP With IF (Clinicians) | Main Study: MiCAP With IF+EF (Clinicians) | Administrative Supplement: Clinicians | Administrative Supplement: Caregivers | Administrative Supplement: Beneficiaries | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 69.5 years STANDARD_DEVIATION 14.58 | 71.19 years STANDARD_DEVIATION 14.02 | 43.07 years STANDARD_DEVIATION 11.57 | 47.00 years STANDARD_DEVIATION 11.59 | 45.78 years STANDARD_DEVIATION 10.48 | 63.28 years STANDARD_DEVIATION 11.29 | 81.23 years STANDARD_DEVIATION 9.27 | 70.35 years STANDARD_DEVIATION 14.32 |
| Emergency Department Visits | 450 Number on scale | 421 Number on scale | — | — | — | — | 12 Number on scale | 883 Number on scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 108 Participants | 97 Participants | 13 Participants | 5 Participants | 5 Participants | 1 Participants | 1 Participants | 230 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3357 Participants | 3401 Participants | 267 Participants | 247 Participants | 101 Participants | 49 Participants | 51 Participants | 7473 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 32 Participants | 35 Participants | 2 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 74 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 25 Participants | 9 Participants | 5 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 42 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 25 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 56 Participants |
| Race (NIH/OMB) Black or African American | 541 Participants | 1228 Participants | 14 Participants | 39 Participants | 2 Participants | 4 Participants | 4 Participants | 1832 Participants |
| Race (NIH/OMB) More than one race | 49 Participants | 33 Participants | 10 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 97 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 119 Participants | 112 Participants | 4 Participants | 7 Participants | 5 Participants | 0 Participants | 0 Participants | 247 Participants |
| Race (NIH/OMB) White | 2735 Participants | 2122 Participants | 248 Participants | 202 Participants | 99 Participants | 44 Participants | 46 Participants | 5496 Participants |
| Region of Enrollment United States | 3497 participants | 3533 participants | 282 participants | 257 participants | 106 participants | 50 participants | 52 participants | 7777 participants |
| Sex/Gender, Customized Sex Female | 2360 Participants | 2403 Participants | 266 Participants | 231 Participants | 103 Participants | 40 Participants | 40 Participants | 5443 Participants |
| Sex/Gender, Customized Sex Male | 1137 Participants | 1130 Participants | 16 Participants | 22 Participants | 3 Participants | 10 Participants | 12 Participants | 2330 Participants |
| Sex/Gender, Customized Sex Unknown | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,497 | 0 / 3,533 | 0 / 282 | 0 / 257 | 0 / 106 | 0 / 50 | 7 / 52 |
| other Total, other adverse events | 0 / 3,497 | 0 / 3,533 | 0 / 282 | 0 / 257 | 0 / 106 | 0 / 50 | 7 / 52 |
| serious Total, serious adverse events | 0 / 3,497 | 0 / 3,533 | 0 / 282 | 0 / 257 | 0 / 106 | 0 / 50 | 0 / 52 |
Outcome results
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.
Time frame: 9 months
Population: The participants analyzed were the 18 waiver sites from the MAIN STUDY that were then randomized to either MiCAP with IF (n=9) or MiCAP with IF and EF (n=9).~The Administrative Supplement Arms/Groups are not included in this outcome as data were only collected during the main study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiCAP With IF | Main Study: Effect of MiCAP With IF Alone Versus MiCAP With IF+EF on Site-level Outcomes of Adoption and Sustainability of CAPABLE | 72.22 score on a scale | Standard Deviation 16.98 |
| MiCAP With IF and EF | Main Study: Effect of MiCAP With IF Alone Versus MiCAP With IF+EF on Site-level Outcomes of Adoption and Sustainability of CAPABLE | 61.33 score on a scale | Standard Deviation 19.29 |
Comparison: Given 18 sites (9 in each arm) available in Michigan, in the comparison of site-level outcome of adoption and sustainability, the detectable effect size with power of 0.80 in two-sided tests at .05 level of significance was d=1.41.p-value: 0.2295% CI: [-7.27, 29.05]t-test, 2 sided
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.
Time frame: Exit (9-months)
Population: Participants analyzed were the beneficiaries at sites (18); arms included randomized to either MiCAP with IF (n=9) or MiCAP with IF and EF (n=9).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiCAP With IF | Main Study: Beneficiary's ADLs Summed Score | 26.13 Score on scale | Standard Error 0.2 |
| MiCAP With IF and EF | Main Study: Beneficiary's ADLs Summed Score | 25.85 Score on scale | Standard Error 0.19 |
Comparison: Adjusted means at month 9 were calculated adjusting for baseline value of the outcome and nesting of participants within sites.p-value: 0.7395% CI: [-0.16, 0.73]Mixed Models Analysis
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.
Time frame: Exit (9-months)
Population: The participants analyzed were the 18 waiver sites from the MAIN STUDY that were then randomized to either MiCAP with IF (n=9) or MiCAP with IF and EF (n=9).~Arms /Groups MiCAP with IF (Main Study: Clinicians), MiCAP with IF and EF (Main Study: Clinicians), Administrative Supplement: Clinicians, and Administrative Supplement: Caregivers, and Administrative Supplement: Beneficiaries were not included as data was not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiCAP With IF | Main Study: Beneficiary's Depression | 1.3 Score on scale | Standard Error 0.05 |
| MiCAP With IF and EF | Main Study: Beneficiary's Depression | 1.17 Score on scale | Standard Error 0.05 |
p-value: 0.0495% CI: [0.01, 0.24]F-test
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.
Time frame: Exit (9-months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiCAP With IF | Main Study: Beneficiary's Emergency Department (ED) Visits Occurrences Out of Total Number of Participants. | 0.92 percentage of participants | Standard Error 0.01 |
| MiCAP With IF and EF | Main Study: Beneficiary's Emergency Department (ED) Visits Occurrences Out of Total Number of Participants. | 0.91 percentage of participants | Standard Error 0.01 |
p-value: 0.8695% CI: [0.79, 1.22]Mixed Models Analysis
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.
Time frame: Exit (9-months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiCAP With IF | Main Study: Beneficiary's Fall Rate | 0.15 percentage of participants | Standard Error 0.01 |
| MiCAP With IF and EF | Main Study: Beneficiary's Fall Rate | 0.14 percentage of participants | Standard Error 0.01 |
p-value: 0.1895% CI: [0.93, 1.45]Mixed Models Analysis
Comparison: Occurrence of falls was analyzed with adjustment for baseline and nesting of participants within sites.p-value: 0.1895% CI: [0.93, 1.45]Mixed Models Analysis
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.
Time frame: Exit (9-months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiCAP With IF | Main Study: Beneficiary's Hospitalization Occurrences Out of Total Number of Participants. | 0.01 percentage of participants | Standard Error 0.01 |
| MiCAP With IF and EF | Main Study: Beneficiary's Hospitalization Occurrences Out of Total Number of Participants. | .01 percentage of participants | Standard Error 0.01 |
p-value: 0.9595% CI: [0.72, 1.42]F-test
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.
Time frame: Exit (9-months)
Population: The participants analyzed were the 18 waiver sites from the MAIN STUDY that were then randomized to either MiCAP with IF (n=9) or MiCAP with IF and EF (n=9).~Arms /Groups MiCAP with IF (Main Study: Clinicians), MiCAP with IF and EF (Main Study: Clinicians), Administrative Supplement: Clinicians, and Administrative Supplement: Caregivers, and Administrative Supplement: Beneficiaries were not included as data was not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiCAP With IF | Main Study: Beneficiary's IADLs | 29.54 Score on scale | Standard Error 0.17 |
| MiCAP With IF and EF | Main Study: Beneficiary's IADLs | 29.24 Score on scale | Standard Error 0.17 |
Comparison: Post-intervention means were compared adjusting for baseline values and nesting of participants within sites.p-value: 0.1595% CI: [-0.11, 0.72]Mixed Models Analysis
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).
Time frame: Exit (9-months)
Population: The participants analyzed were the 18 waiver sites from the MAIN STUDY that were then randomized to either MiCAP with IF (n=9) or MiCAP with IF and EF (n=9).~Arms /Groups MiCAP with IF (Main Study: Clinicians), MiCAP with IF and EF (Main Study: Clinicians), Administrative Supplement: Clinicians, and Administrative Supplement: Caregivers, and Administrative Supplement: Beneficiaries were not included as data was not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiCAP With IF | Main Study: Beneficiary's Pain | 7.52 Score on scale | Standard Error 0.13 |
| MiCAP With IF and EF | Main Study: Beneficiary's Pain | 7.44 Score on scale | Standard Error 0.13 |
p-value: 0.6195% CI: [-0.23, 0.39]Mixed Models Analysis
Other Pre-specified
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.
Time frame: 9-months
Population: Informal caregivers enrolled in study to care for beneficiaries in the waiver program.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MiCAP With IF | Administrative Supplement: Acceptability of Caregiver Use of Intervention With Beneficiaries. | 813 Count of caregiver use of toolkit |
Other Pre-specified
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
Time frame: Baseline (0-months) compared to Exit (9-months)
Population: Beneficiaries with Alzheimer's Disease or other dementia in the waiver program.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MiCAP With IF | 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. | Depression | 5.52 Score on scale | Standard Deviation 8.75 |
| MiCAP With IF | 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. | IADLs | 42.69 Score on scale | Standard Deviation 9.67 |
| MiCAP With IF | 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. | ADLs | 22.44 Score on scale | Standard Deviation 17.09 |
| MiCAP With IF | 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. | Pain | 2.85 Score on scale | Standard Deviation 2.91 |
| MiCAP With IF and EF | 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. | Pain | 5.56 Score on scale | Standard Deviation 3.36 |
| MiCAP With IF and EF | 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. | Depression | 4.52 Score on scale | Standard Deviation 4.47 |
| MiCAP With IF and EF | 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. | ADLs | 23.49 Score on scale | Standard Deviation 19.56 |
| MiCAP With IF and EF | 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. | IADLs | 42.22 Score on scale | Standard Deviation 11.4 |
Comparison: Painp-value: <0.0195% CI: [-3.96, -1.42]t-test, 2 sided
Comparison: ADLp-value: 0.5895% CI: [-2.8, 4.91]t-test, 2 sided
Comparison: IADLp-value: 0.4495% CI: [-2.8, 4.91]t-test, 2 sided
Comparison: Depressionp-value: 0.3895% CI: [-1.85, 4.77]t-test, 2 sided
Other Pre-specified
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).
Time frame: Self-efficacy: baseline (month-0) and Exit (month-4). Satisfaction: Monthly for month 0 (baseline), 1, 2, 3, 4 (exit)
Population: Informal caregivers who care for beneficiaries with Alzheimer's Disease or other dementia's in waiver program. Data not collected on the following items. Self-efficacy at Month 1, Month 2 or Month 3 (only collected at baseline month-0 and exit month-4). Satisfaction with Content of Intervention, Format of Intervention, and Helpfulness of Intervention was not collected at Baseline Month-0 (only collected at Month 1-Month-2, Month-3, Month-4 Exit).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MiCAP With IF | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Self-efficacy | 2.67 units on a scale | Standard Deviation 0.62 |
| MiCAP With IF and EF | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Satisfaction with format of intervention | 8.95 units on a scale | Standard Deviation 1.77 |
| MiCAP With IF and EF | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Satisfaction with content of intervention | 8.87 units on a scale | Standard Deviation 1.7 |
| MiCAP With IF and EF | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Self-efficacy | 3.42 units on a scale | Standard Deviation 0.38 |
| MiCAP With IF and EF | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Helpfulness of intervention | 7.98 units on a scale | Standard Deviation 2.16 |
| Beneficiaries Enrolled in the Study. | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Satisfaction with format of intervention | 9.58 units on a scale | Standard Deviation 0.84 |
| Beneficiaries Enrolled in the Study. | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Satisfaction with content of intervention | 9.03 units on a scale | Standard Deviation 1.65 |
| Beneficiaries Enrolled in the Study. | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Helpfulness of intervention | 8.79 units on a scale | Standard Deviation 1.88 |
| Administrative Supplement: Group-Caregivers (Month-2) | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Satisfaction with format of intervention | 9.28 units on a scale | Standard Deviation 1.25 |
| Administrative Supplement: Group-Caregivers (Month-2) | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Satisfaction with content of intervention | 9.07 units on a scale | Standard Deviation 1.44 |
| Administrative Supplement: Group-Caregivers (Month-2) | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Helpfulness of intervention | 8.79 units on a scale | Standard Deviation 1.88 |
| Administrative Supplement: Group-Caregivers (Month-3) | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Satisfaction with format of intervention | 9.33 units on a scale | Standard Deviation 1.71 |
| Administrative Supplement: Group-Caregivers (Month-3) | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Helpfulness of intervention | 8.23 units on a scale | Standard Deviation 2.34 |
| Administrative Supplement: Group-Caregivers (Month-3) | Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention. | Satisfaction with content of intervention | 8.60 units on a scale | Standard Deviation 2.27 |
Comparison: Self-efficacy change baseline (month-0) to exit (month-4).p-value: <0.0195% CI: [-1.02, -0.6]t-test, 2 sided
Other Pre-specified
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).
Time frame: 9-months
Population: There are three groups in this study: Clinicians at 3 sites who work with the caregivers to help them care for the beneficiaries in the waiver program.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MiCAP With IF | Administrative Supplement: Clinician Satisfaction With Training and Use of Intervention. | Satisfaction with newness of content for clinician | 7.85 Satisfaction rate (scale 1-10, 1=poorest | Standard Deviation 1.92 |
| MiCAP With IF | Administrative Supplement: Clinician Satisfaction With Training and Use of Intervention. | Satisfaction with content | 8.09 Satisfaction rate (scale 1-10, 1=poorest | Standard Deviation 1.6 |
| MiCAP With IF | Administrative Supplement: Clinician Satisfaction With Training and Use of Intervention. | Satisfaction with format | 7.55 Satisfaction rate (scale 1-10, 1=poorest | Standard Deviation 2.06 |
| MiCAP With IF | Administrative Supplement: Clinician Satisfaction With Training and Use of Intervention. | Satisfaction with newness of content for caregiver | 8.35 Satisfaction rate (scale 1-10, 1=poorest | Standard Deviation 1.5 |
| MiCAP With IF | Administrative Supplement: Clinician Satisfaction With Training and Use of Intervention. | Intent to use new information | 8.23 Satisfaction rate (scale 1-10, 1=poorest | Standard Deviation 1.71 |
p-value: <0.01t-test, 2 sided
Comparison: Satisfaction with formatp-value: <0.01t-test, 2 sided
Comparison: Satisfaction with newness of content for caregiverp-value: <0.01Difference from zero
Comparison: Satisfaction with newness of content for clinicianp-value: <0.01Difference from zero
Comparison: Intent to use new informationp-value: <0.01Difference from zero
Other Pre-specified
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.
Time frame: Recruitment period of 9-months.
Population: Caregivers: \>21 years of age, an Informal Caregiver for a beneficiary in Medicaid waiver program.~Clinicians: \>21 years of age employed as RN or SW in waiver program where study conducted.~Beneficiary: \>21 years of age and enrolled in waiver program, and diagnosed with Alzheimer's disease or other dementia.~NOTES:~* 1 Overall Number of Participants Analyzed: is the total number recruited.~* 2 The Measure Type in Outcome Measure Data Table is the number enrolled of the number recruited.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiCAP With IF | Administrative Supplement: Feasibility of Use of Intervention With Clinicians, Caregivers and Beneficiaries. | 50 Participants |
| MiCAP With IF and EF | Administrative Supplement: Feasibility of Use of Intervention With Clinicians, Caregivers and Beneficiaries. | 106 Participants |
| Beneficiaries Enrolled in the Study. | Administrative Supplement: Feasibility of Use of Intervention With Clinicians, Caregivers and Beneficiaries. | 52 Participants |
Other Pre-specified
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.
Time frame: Exit (9-months)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Overall Attitude (total summed mean score) | -103.49 units on a scale | Standard Error 0.92 |
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude limitations | 0.00 units on a scale | Standard Error 0.11 |
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude openness | 0.08 units on a scale | Standard Error 0.08 |
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude monitoring | 0.01 units on a scale | Standard Error 0.14 |
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude requirements | 0.15 units on a scale | Standard Error 0.09 |
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude employabilty | -0.17 units on a scale | Standard Error 0.07 |
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude feedback (higher is better) | 0.10 units on a scale | Standard Error 0.11 |
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude burden | 0.13 units on a scale | Standard Error 0.15 |
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude appeal | 0.06 units on a scale | Standard Error 0.08 |
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude divergence | 0.07 units on a scale | Standard Error 0.09 |
| MiCAP With IF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude balance | 0.11 units on a scale | Standard Error 0.11 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude balance | 0.21 units on a scale | Standard Error 0.1 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude feedback (higher is better) | -0.01 units on a scale | Standard Error 0.12 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude limitations | -0.06 units on a scale | Standard Error 0.11 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude divergence | 0.14 units on a scale | Standard Error 0.09 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude openness | 0.00 units on a scale | Standard Error 0.08 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude burden | 0.04 units on a scale | Standard Error 0.14 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude monitoring | 0.18 units on a scale | Standard Error 0.14 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Overall Attitude (total summed mean score) | -103.52 units on a scale | Standard Error 0.92 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude requirements | 0.18 units on a scale | Standard Error 0.14 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude appeal | -0.11 units on a scale | Standard Error 0.08 |
| MiCAP With IF and EF | Main Study: Clinician Attitude Towards Evidence Based Practice Use | Attitude employabilty | -0.04 units on a scale | Standard Error 0.11 |
Comparison: Mixed modeling was used to account for nesting of clinicians within sites.p-value: 0.0595% CI: [0.09, 10.14]Mixed Models Analysis
Other Pre-specified
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.
Time frame: Exit (9-months)
Population: Clinicians.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiCAP With IF | Main Study: Clinician Self-efficacy | -2.34 Score on scale | Standard Error 0.21 |
| MiCAP With IF and EF | Main Study: Clinician Self-efficacy | -2.57 Score on scale | Standard Error 0.3 |
p-value: 0.5495% CI: [-0.51, 0.97]Mixed Models Analysis