- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07309224
Employing Peer Outreach and Whole Health in Recovery for Homeless-Experienced Veterans (EMPOWER)
Employing Peer Outreach and Whole Health in Recovery (EMPOWER) for Homeless-Experienced Veterans: A Hybrid Type III Implementation Trial (QUE 25-014)
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: Homelessness is a national crisis in the United States, particularly in the Veteran population. Due to multiple chronic conditions, homeless individuals have elevated risk for acute care service use. Engagement in primary and specialty care can mitigate this risk. Interventions grounded in evidence-based practices of peer support, patient-centered care, and whole health are effective for increasing service engagement. However, implementation of such interventions with high-acuity patients often requires multi-component strategies that are intensive and costly. This study protocol describes a hybrid type 3 effectiveness-implementation trial of Employing Peer Outreach and Whole Health in Recovery (EMPOWER) with high-need, homeless-experienced Veterans in permanent supportive housing and will evaluate the impact and cost of a high-intensity (vs. low-intensity) strategy on implementation outcomes.
Methods: (Aim 1) At 7 sites in the Veterans Health Administration (VA), a mixed methods pre-implementation evaluation will identify determinants and their potential impact on uptake of the EMPOWER and inform modifications to the intervention and implementation strategies as needed. (Aim 2) A staircase cluster randomized design will evaluate the rollout of the implementation strategies, beginning with Audit and Feedback (low-intensity) and then switching to Facilitation (high-intensity) after 6 months. Facilitation is hypothesized to have a greater impact on the reach, effectiveness, adoption, implementation (fidelity), and maintenance of EMPOWER. (Aim 3) A budget impact analysis will estimate the average cost of implementing EMPOWER at future sites and comparative costs for implementing the low- and high-intensity strategies.
Anticipated Impact: This study will provide information on the relative impacts and relative costs of strategies aimed at implementing a peer-led, patient-centered, whole health intervention for homeless-experienced Veterans in permanent supportive housing. The findings will provide guidance to VA and other healthcare systems that serve the aging population of homeless-experienced Veterans.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel M Blonigen, PhD MA
- Phone Number: 27828 (650) 493-5000
- Email: Daniel.Blonigen@va.gov
Study Contact Backup
- Name: Jennifer S Smith, MPH
- Phone Number: 27831 (650) 493-5000
- Email: jennifer.s.smith@va.gov
Study Locations
-
-
California
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Palo Alto, California, United States, 94304-1207
- VA Palo Alto Health Care System, Palo Alto, CA
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Principal Investigator:
- Daniel M. Blonigen, PhD MA
-
Contact:
- Daniel M Blonigen, PhD MA
- Phone Number: 27828 650-493-5000
- Email: Daniel.Blonigen@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Eligible patients will be identified from VA's Homeless Registry "Hot Spot" reports, which use real-time data on acute care service utilization to identify high-need, housing-insecure patients.
- These reports identify Veterans on the VA Homeless Registry (i.e., those who had received VA housing services in the past two years) who had >1 hospital admissions and/or >2 ED visits in the past quarter of the fiscal year.
From these reports, the investigators will identify patients at each implementation site who are
- (a) currently enrolled in HUD-VASH
- (b) have a mental health and/or SUD diagnosis
Exclusion Criteria:
- Not flagged on the VA's Homeless Registry Hot Spot Report
- Not currently enrolled in HUD-VASH
- Does not have a mental health and/or substance use disorder diagnosis
- Is not a patient at a participating site of the implementation trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Low-Intensity (LI)
For the LI phase of a site's implementation, a light-touch strategy will be used to implement EMPOWER; specifically, Audit and Feedback.
In Audit and Feedback, key stakeholders at sites receive summarized data about their performance relative to a standard or benchmark.
Specifically, HUD-VASH peers and supervisors at each site will be emailed monthly automated reports on EMPOWER fidelity data from the EHR (e.g., % of HUD-VASH patients with a Personal Health Plan note) as well as aggregated data on treatment engagement via the Hot Spot dashboard (e.g., % of HUD-VASH Veterans with an SUD diagnosis who received SUD specialty care in the past month).
The monthly reports will include tailored action item recommendations based on the local site's performance.
Under the LI strategy, sites will not be provided interactive support to review these reports.
|
EMPOWER is a multicomponent intervention to facilitate homeless-experienced veterans' (HEVs) care engagement: (DATA ANALYTICS) HUD-VASH case managers identify high-need, HUD-VASH Veterans on the Homeless Registry Hot Spot Report.
Veterans' profiles are reviewed to learn about their chronic health conditions, housing status, acute care use, and engagement in supportive care.
(PEER SUPPORT): HUD-VASH peers meet with identified Veterans for up to six months, averaging once-per week sessions for the first three months, with step-down in frequency as Veterans begin to engage in services and reach their goals.
(WHOLE HEALTH): During sessions, peers use a Whole Health approach to collaboratively develop personal health goals that align with the Veteran's priorities and values-e.g,
help Veterans completing a Personal Health Inventory and developing a Personal Health Plans.
Provider communications: Peers communicate with a Veteran's care providers to share the Veteran's personal health goals.
Other Names:
|
|
Experimental: High-Intensity (HI)
For the HI phase of a site's implementation, a higher-intensity strategy will be used to implement EMPOWER; specifically, Facilitation.
Facilitation is a collaborative strategy in which trained individuals work with organizations or teams to support the adoption, implementation, and sustainment of an evidence-based practice (EBP).
It is a dynamic process that involves tailored guidance, problem-solving, technical assistance, and capacity-building activities to address specific barriers and leverage facilitators of change.
To this end, external facilitators often collaborate with local champions to bring expertise regarding the implementation processes and have transferable knowledge in relevant clinical and behavior change models that inform the EBP's implementation.
|
EMPOWER is a multicomponent intervention to facilitate homeless-experienced veterans' (HEVs) care engagement: (DATA ANALYTICS) HUD-VASH case managers identify high-need, HUD-VASH Veterans on the Homeless Registry Hot Spot Report.
Veterans' profiles are reviewed to learn about their chronic health conditions, housing status, acute care use, and engagement in supportive care.
(PEER SUPPORT): HUD-VASH peers meet with identified Veterans for up to six months, averaging once-per week sessions for the first three months, with step-down in frequency as Veterans begin to engage in services and reach their goals.
(WHOLE HEALTH): During sessions, peers use a Whole Health approach to collaboratively develop personal health goals that align with the Veteran's priorities and values-e.g,
help Veterans completing a Personal Health Inventory and developing a Personal Health Plans.
Provider communications: Peers communicate with a Veteran's care providers to share the Veteran's personal health goals.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach
Time Frame: 18 months
|
Reach will be measured in terms of the number of patients who are willing to receive EMPOWER, out of all patients that are estimated to be eligible at potential sites.
|
18 months
|
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Adoption
Time Frame: 18 months
|
Adoption will be measured in terms of the number of peers in HUD-VASH at sites that are trained in EMPOWER and initiate the intervention with eligible patients at their site.
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18 months
|
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Maintenance
Time Frame: 18 months
|
Maintenance will be measured by the number of patients who are continuing to engage in EMPOWER and other VA services over the duration of the implementation phase (18 months).
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18 months
|
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Implementation
Time Frame: 18 months
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Implementation will be measured in terms of rate of completion of peer encounters at the site level and rate of completion of the elements of EMPOWER (e.g., percentage of EMPOWER patients with a Personal Health Plan entered into the EHR; percentage of EMPOWER patients who were referred to a Whole Health service at the local facility).
These rates will be measured via activity logs embedded in the EHR and electronic data capture logs to document type and length of encounters.
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness - Mental Health Outpatient Care
Time Frame: 6 months
|
Among patients who receive EMPOWER and have a mental health diagnosis, the number of outpatient visits for mental health care they receive after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters).
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6 months
|
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Effectiveness - Substance Use Disorder Outpatient Care
Time Frame: 6 months
|
Among patients who receive EMPOWER and have a diagnosis of a substance use disorder (SUD), the number of outpatient visits for SUD care they receive after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters).
|
6 months
|
|
Effectiveness - Primary Care
Time Frame: 6 months
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Among patients who receive EMPOWER, the number of primary care visits they attend after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters).
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6 months
|
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Effectiveness - Whole Health care
Time Frame: 6 months
|
Among patients who receive EMPOWER, the number of outpatient visits for Whole Health-related care they receive after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters of health coaching and other complementary and integrative services).
|
6 months
|
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Effectiveness - Hospitalizations
Time Frame: 6 months
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Among patients who receive EMPOWER, the number of bed days of care for ambulatory-care sensitive conditions after 6 months, as measured by VA administrative data (e.g., Bedsection codes).
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6 months
|
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Effectiveness - ED visits
Time Frame: 6 months
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Among patients who receive EMPOWER, the number of visits to an emergency department after 6 months, as measured by VA administrative data (e.g., stop codes).
|
6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Daniel M. Blonigen, PhD MA, VA Palo Alto Health Care System, Palo Alto, CA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QUX 26-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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