Trial Outcomes & Findings for Implementation of CAPABLE in the Michigan Medicaid Waiver (NCT NCT03634033)

NCT ID: NCT03634033

Last Updated: 2022-11-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7777 participants

Primary outcome timeframe

9 months

Results posted on

2022-11-30

Participant Flow

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.

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.

Unit of analysis: Sites (Main Study only)

Participant milestones

Participant milestones
Measure
MiCAP With IF (Main Study: 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
MiCAP With IF and EF (Main Study: 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.
MiCAP With IF (Main Study: 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
MiCAP With IF and EF (Main Study: 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.
Administrative Supplement: Clinicians
Clinicians who were employed at the waiver sites and were trained in using CAPABLE with caregivers of beneficiaries with Alzheimer's Disease or Dementia; plus MiCAP with IF from Main Study.
Administrative Supplement: Caregivers
Caregivers of beneficiaries diagnosed with Alzheimer's Disease or Dementia who agreed to assist with providing CAPABLE to their beneficiary; plus MiCAP with IF from Main Study.
Administrative Supplement: Beneficiaries
Beneficiaries enrolled at the waiver who were diagnosed with Alzheimer's Disease or Dementia and needed to receive CAPABLE; ; plus MiCAP with IF from Main Study.
Overall Study
STARTED
3497 9
3533 9
282 9
257 9
106 3
50 3
52 3
Overall Study
COMPLETED
3113 9
3242 9
168 9
96 9
101 3
37 3
37 3
Overall Study
NOT COMPLETED
384 0
291 0
114 0
161 0
5 0
13 0
15 0

Reasons for withdrawal

Reasons for withdrawal
Measure
MiCAP With IF (Main Study: 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
MiCAP With IF and EF (Main Study: 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.
MiCAP With IF (Main Study: 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
MiCAP With IF and EF (Main Study: 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.
Administrative Supplement: Clinicians
Clinicians who were employed at the waiver sites and were trained in using CAPABLE with caregivers of beneficiaries with Alzheimer's Disease or Dementia; plus MiCAP with IF from Main Study.
Administrative Supplement: Caregivers
Caregivers of beneficiaries diagnosed with Alzheimer's Disease or Dementia who agreed to assist with providing CAPABLE to their beneficiary; plus MiCAP with IF from Main Study.
Administrative Supplement: Beneficiaries
Beneficiaries enrolled at the waiver who were diagnosed with Alzheimer's Disease or Dementia and needed to receive CAPABLE; ; plus MiCAP with IF from Main Study.
Overall Study
Did not have a post-assessment
384
291
114
161
5
0
0
Overall Study
Death
0
0
0
0
0
7
7
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

ED data was not collected for MiCAP with IF (Main Study: Clinicians), MiCAP with IF and EF (Main Study: Clinicians), Administrative Supplement: Clinicians, and Administrative Supplement: Caregivers.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Main Study: MiCAP With IF (Beneficiaries)
n=3497 Participants
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
Main Study: MiCAP With IF+EF (Beneficiaries)
n=3533 Participants
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.
Main Study: MiCAP With IF (Clinicians)
n=282 Participants
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
Main Study: MiCAP With IF+EF (Clinicians)
n=257 Participants
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.
Administrative Supplement: Clinicians
n=106 Participants
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.
Administrative Supplement: Caregivers
n=50 Participants
Caregivers of beneficiaries diagnosed with Alzheimer's Disease or Dementia who will receive the toolkit to assist in taking care of their beneficiary.
Administrative Supplement: Beneficiaries
n=52 Participants
Beneficiaries enrolled at the waiver who were diagnosed with Alzheimer's Disease or Dementia.
Total
n=7777 Participants
Total of all reporting groups
Age, Continuous
69.5 years
STANDARD_DEVIATION 14.58 • n=3497 Participants
71.19 years
STANDARD_DEVIATION 14.02 • n=3533 Participants
43.07 years
STANDARD_DEVIATION 11.57 • n=282 Participants
47.00 years
STANDARD_DEVIATION 11.59 • n=257 Participants
45.78 years
STANDARD_DEVIATION 10.48 • n=106 Participants
63.28 years
STANDARD_DEVIATION 11.29 • n=50 Participants
81.23 years
STANDARD_DEVIATION 9.27 • n=52 Participants
70.35 years
STANDARD_DEVIATION 14.32 • n=7777 Participants
Sex/Gender, Customized
Sex · Male
1137 Participants
n=3497 Participants
1130 Participants
n=3533 Participants
16 Participants
n=282 Participants
22 Participants
n=257 Participants
3 Participants
n=106 Participants
10 Participants
n=50 Participants
12 Participants
n=52 Participants
2330 Participants
n=7777 Participants
Sex/Gender, Customized
Sex · Female
2360 Participants
n=3497 Participants
2403 Participants
n=3533 Participants
266 Participants
n=282 Participants
231 Participants
n=257 Participants
103 Participants
n=106 Participants
40 Participants
n=50 Participants
40 Participants
n=52 Participants
5443 Participants
n=7777 Participants
Sex/Gender, Customized
Sex · Unknown
0 Participants
n=3497 Participants
0 Participants
n=3533 Participants
0 Participants
n=282 Participants
4 Participants
n=257 Participants
0 Participants
n=106 Participants
0 Participants
n=50 Participants
0 Participants
n=52 Participants
4 Participants
n=7777 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
108 Participants
n=3497 Participants
97 Participants
n=3533 Participants
13 Participants
n=282 Participants
5 Participants
n=257 Participants
5 Participants
n=106 Participants
1 Participants
n=50 Participants
1 Participants
n=52 Participants
230 Participants
n=7777 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3357 Participants
n=3497 Participants
3401 Participants
n=3533 Participants
267 Participants
n=282 Participants
247 Participants
n=257 Participants
101 Participants
n=106 Participants
49 Participants
n=50 Participants
51 Participants
n=52 Participants
7473 Participants
n=7777 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
32 Participants
n=3497 Participants
35 Participants
n=3533 Participants
2 Participants
n=282 Participants
5 Participants
n=257 Participants
0 Participants
n=106 Participants
0 Participants
n=50 Participants
0 Participants
n=52 Participants
74 Participants
n=7777 Participants
Race (NIH/OMB)
American Indian or Alaska Native
25 Participants
n=3497 Participants
9 Participants
n=3533 Participants
5 Participants
n=282 Participants
1 Participants
n=257 Participants
0 Participants
n=106 Participants
1 Participants
n=50 Participants
1 Participants
n=52 Participants
42 Participants
n=7777 Participants
Race (NIH/OMB)
Asian
25 Participants
n=3497 Participants
25 Participants
n=3533 Participants
1 Participants
n=282 Participants
4 Participants
n=257 Participants
0 Participants
n=106 Participants
0 Participants
n=50 Participants
1 Participants
n=52 Participants
56 Participants
n=7777 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants
n=3497 Participants
4 Participants
n=3533 Participants
0 Participants
n=282 Participants
0 Participants
n=257 Participants
0 Participants
n=106 Participants
0 Participants
n=50 Participants
0 Participants
n=52 Participants
7 Participants
n=7777 Participants
Race (NIH/OMB)
Black or African American
541 Participants
n=3497 Participants
1228 Participants
n=3533 Participants
14 Participants
n=282 Participants
39 Participants
n=257 Participants
2 Participants
n=106 Participants
4 Participants
n=50 Participants
4 Participants
n=52 Participants
1832 Participants
n=7777 Participants
Race (NIH/OMB)
White
2735 Participants
n=3497 Participants
2122 Participants
n=3533 Participants
248 Participants
n=282 Participants
202 Participants
n=257 Participants
99 Participants
n=106 Participants
44 Participants
n=50 Participants
46 Participants
n=52 Participants
5496 Participants
n=7777 Participants
Race (NIH/OMB)
More than one race
49 Participants
n=3497 Participants
33 Participants
n=3533 Participants
10 Participants
n=282 Participants
4 Participants
n=257 Participants
0 Participants
n=106 Participants
1 Participants
n=50 Participants
0 Participants
n=52 Participants
97 Participants
n=7777 Participants
Race (NIH/OMB)
Unknown or Not Reported
119 Participants
n=3497 Participants
112 Participants
n=3533 Participants
4 Participants
n=282 Participants
7 Participants
n=257 Participants
5 Participants
n=106 Participants
0 Participants
n=50 Participants
0 Participants
n=52 Participants
247 Participants
n=7777 Participants
Region of Enrollment
United States
3497 participants
n=3497 Participants
3533 participants
n=3533 Participants
282 participants
n=282 Participants
257 participants
n=257 Participants
106 participants
n=106 Participants
50 participants
n=50 Participants
52 participants
n=52 Participants
7777 participants
n=7777 Participants
Emergency Department Visits
450 Number on scale
n=3497 Participants • ED data was not collected for MiCAP with IF (Main Study: Clinicians), MiCAP with IF and EF (Main Study: Clinicians), Administrative Supplement: Clinicians, and Administrative Supplement: Caregivers.
421 Number on scale
n=3533 Participants • ED data was not collected for MiCAP with IF (Main Study: Clinicians), MiCAP with IF and EF (Main Study: Clinicians), Administrative Supplement: Clinicians, and Administrative Supplement: Caregivers.
12 Number on scale
n=52 Participants • ED data was not collected for MiCAP with IF (Main Study: Clinicians), MiCAP with IF and EF (Main Study: Clinicians), Administrative Supplement: Clinicians, and Administrative Supplement: Caregivers.
883 Number on scale
n=7082 Participants • ED data was not collected for MiCAP with IF (Main Study: Clinicians), MiCAP with IF and EF (Main Study: Clinicians), Administrative Supplement: Clinicians, and Administrative Supplement: Caregivers.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=9 waiver sites
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
MiCAP With IF and EF
n=9 waiver sites
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
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
61.33 score on a scale
Standard Deviation 19.29

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=9 Waiver Sites
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
MiCAP With IF and EF
n=9 Waiver Sites
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Main Study: Beneficiary's ADLs Summed Score
26.13 Score on scale
Standard Error 0.20
25.85 Score on scale
Standard Error 0.19

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=9 Waiver Sites
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
MiCAP With IF and EF
n=9 Waiver Sites
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Main Study: Beneficiary's IADLs
29.54 Score on scale
Standard Error 0.17
29.24 Score on scale
Standard Error 0.17

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=9 Waiver Sites
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
MiCAP With IF and EF
n=9 Waiver Sites
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Main Study: Beneficiary's Pain
7.52 Score on scale
Standard Error 0.13
7.44 Score on scale
Standard Error 0.13

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=9 Waiver Sites
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
MiCAP With IF and EF
n=9 Waiver Sites
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Main Study: Beneficiary's Depression
1.3 Score on scale
Standard Error 0.05
1.17 Score on scale
Standard Error 0.05

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=3397 Participants
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
MiCAP With IF and EF
n=3533 Participants
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Main Study: Beneficiary's Fall Rate
0.15 percentage of participants
Standard Error 0.01
0.14 percentage of participants
Standard Error 0.01

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=3387 Participants
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
MiCAP With IF and EF
n=3533 Participants
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Main Study: Beneficiary's Emergency Department (ED) Visits Occurrences Out of Total Number of Participants.
0.92 percentage of participants
Standard Error .01
0.91 percentage of participants
Standard Error .01

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=3387 Participants
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
MiCAP With IF and EF
n=3553 Participants
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Main Study: Beneficiary's Hospitalization Occurrences Out of Total Number of Participants.
0.01 percentage of participants
Standard Error .01
.01 percentage of participants
Standard Error .01

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=282 Participants
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
MiCAP With IF and EF
n=257 Participants
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Attitude limitations
0.00 units on a scale
Standard Error 0.11
-0.06 units on a scale
Standard Error 0.11
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Attitude openness
0.08 units on a scale
Standard Error 0.08
0.00 units on a scale
Standard Error 0.08
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Attitude monitoring
0.01 units on a scale
Standard Error 0.14
0.18 units on a scale
Standard Error 0.14
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Attitude requirements
0.15 units on a scale
Standard Error 0.09
0.18 units on a scale
Standard Error 0.14
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Attitude employabilty
-0.17 units on a scale
Standard Error 0.07
-0.04 units on a scale
Standard Error 0.11
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Attitude feedback (higher is better)
0.10 units on a scale
Standard Error 0.11
-0.01 units on a scale
Standard Error 0.12
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Attitude burden
0.13 units on a scale
Standard Error 0.15
0.04 units on a scale
Standard Error 0.14
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Attitude appeal
0.06 units on a scale
Standard Error 0.08
-0.11 units on a scale
Standard Error 0.08
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Attitude divergence
0.07 units on a scale
Standard Error 0.09
0.14 units on a scale
Standard Error 0.09
Main Study: Clinician Attitude Towards Evidence Based Practice Use
Attitude balance
0.11 units on a scale
Standard Error 0.11
0.21 units on a scale
Standard Error 0.10
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
-103.52 units on a scale
Standard Error 0.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Exit (9-months)

Population: Clinicians.

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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=282 Participants
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
MiCAP With IF and EF
n=257 Participants
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Main Study: Clinician Self-efficacy
-2.34 Score on scale
Standard Error 0.21
-2.57 Score on scale
Standard Error 0.30

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=58 Participants
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
MiCAP With IF and EF
n=135 Participants
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.
Beneficiaries Enrolled in the Study.
n=60 Participants
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Feasibility of Use of Intervention With Clinicians, Caregivers and Beneficiaries.
50 Participants
106 Participants
52 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9-months

Population: Informal caregivers enrolled in study to care for beneficiaries in the waiver program.

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.

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=50 Participants
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
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. 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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Acceptability of Caregiver Use of Intervention With Beneficiaries.
813 Count of caregiver use of toolkit

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (0-months) compared to Exit (9-months)

Population: Beneficiaries with Alzheimer's Disease or other dementia in the waiver program.

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

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=52 Participants
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
MiCAP With IF and EF
n=52 Participants
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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
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
4.52 Score on scale
Standard Deviation 4.47
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
42.22 Score on scale
Standard Deviation 11.40
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
23.49 Score on scale
Standard Deviation 19.56
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
5.56 Score on scale
Standard Deviation 3.36

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

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)".

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=50 Participants
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
MiCAP With IF and EF
n=50 Participants
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.
Beneficiaries Enrolled in the Study.
n=50 Participants
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
n=50 Participants
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
n=50 Participants
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention.
Self-efficacy
2.67 units on a scale
Standard Deviation 0.62
3.42 units on a scale
Standard Deviation 0.38
Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention.
Satisfaction with content of intervention
8.87 units on a scale
Standard Deviation 1.70
9.03 units on a scale
Standard Deviation 1.65
9.07 units on a scale
Standard Deviation 1.44
8.60 units on a scale
Standard Deviation 2.27
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
9.58 units on a scale
Standard Deviation 0.84
9.28 units on a scale
Standard Deviation 1.25
9.33 units on a scale
Standard Deviation 1.71
Administrative Supplement: Caregiver Self Efficacy and Satisfaction With Use of Intervention.
Helpfulness of intervention
7.98 units on a scale
Standard Deviation 2.16
8.79 units on a scale
Standard Deviation 1.88
8.79 units on a scale
Standard Deviation 1.88
8.23 units on a scale
Standard Deviation 2.34

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
MiCAP With IF
n=106 Participants
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
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. 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.
Beneficiaries Enrolled in the Study.
A waiver participant who has an informal caregiver and a diagnosis of Alzheimer's disease or dementia.
Administrative Supplement: Group-Caregivers (Month-2)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Group-Caregivers (Month-3)
Caregivers enrolled in study to care for beneficiaries in the waiver program.
Administrative Supplement: Clinician Satisfaction With Training and Use of Intervention.
Satisfaction with content
8.09 Satisfaction rate (scale 1-10, 1=poorest
Standard Deviation 1.60
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
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 1.50
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
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

Adverse Events

MiCAP With IF (Main Study: Beneficiaries)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MiCAP With IF and EF (Main Study: Beneficiaries)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MiCAP With IF (Main Study: Clinicians)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MiCAP With IF and EF (Main Study: Clinicians)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Administrative Supplement: Clinicians

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Administrative Supplement: Caregivers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Administrative Supplement: Beneficiaries

Serious events: 0 serious events
Other events: 7 other events
Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
MiCAP With IF (Main Study: Beneficiaries)
n=3497 participants at risk
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
MiCAP With IF and EF (Main Study: Beneficiaries)
n=3533 participants at risk
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.
MiCAP With IF (Main Study: Clinicians)
n=282 participants at risk
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
MiCAP With IF and EF (Main Study: Clinicians)
n=257 participants at risk
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.
Administrative Supplement: Clinicians
n=106 participants at risk
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.
Administrative Supplement: Caregivers
n=50 participants at risk
Caregivers of beneficiaries diagnosed with Alzheimer's Disease or Dementia who will receive the toolkit to assist in taking care of their beneficiary.
Administrative Supplement: Beneficiaries
n=52 participants at risk
Beneficiaries enrolled at the waiver who were diagnosed with Alzheimer's Disease or Dementia.
Cardiac disorders
3. Other (Not Including Serious) Adverse Events: anticipated and unanticipated events
0.00%
0/3497 • Main Study: adverse event data were collected baseline through month 9. Administrative Supplement: adverse event data were collected baseline through month 4.
0.00%
0/3533 • Main Study: adverse event data were collected baseline through month 9. Administrative Supplement: adverse event data were collected baseline through month 4.
0.00%
0/282 • Main Study: adverse event data were collected baseline through month 9. Administrative Supplement: adverse event data were collected baseline through month 4.
0.00%
0/257 • Main Study: adverse event data were collected baseline through month 9. Administrative Supplement: adverse event data were collected baseline through month 4.
0.00%
0/106 • Main Study: adverse event data were collected baseline through month 9. Administrative Supplement: adverse event data were collected baseline through month 4.
0.00%
0/50 • Main Study: adverse event data were collected baseline through month 9. Administrative Supplement: adverse event data were collected baseline through month 4.
13.5%
7/52 • Number of events 7 • Main Study: adverse event data were collected baseline through month 9. Administrative Supplement: adverse event data were collected baseline through month 4.

Additional Information

Dr. Sandra Spoelstra

Grand Valley State University

Phone: 616-331-5905

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place