- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07309224
Zapojení vrstevnických služeb a celkového zdraví do procesu uzdravení veteránů s zkušeností bezdomovectví (EMPOWER)
Využití vrstevnické osvěty a celostního zdraví v rámci zotavení (EMPOWER) pro veterány s zkušeností bezdomovectví: Hybridní implementační studie typu III (QUE 25-014)
Homelessness is a national crisis in the United States, particularly in the veteran population. Due to multiple chronic conditions, homeless individuals frequently become hospitalized or are treated in emergency departments. Care engagement can mitigate this risk. Interventions grounded in evidence-based practices of peer support and whole health are effective for increasing care engagement. However, implementation of such interventions with high-acuity patients often requires strategies that are intensive and costly. This trial will evaluate the relative impacts and costs of using a high-intensity (vs. low-intensity) strategy to implement a peer-led, whole health intervention for homeless-experienced Veterans in permanent supportive housing.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Daniel M Blonigen, PhD MA
- Telefonní číslo: 27828 (650) 493-5000
- E-mail: Daniel.Blonigen@va.gov
Studijní záloha kontaktů
- Jméno: Jennifer S Smith, MPH
- Telefonní číslo: 27831 (650) 493-5000
- E-mail: jennifer.s.smith@va.gov
Studijní místa
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California
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Palo Alto, California, Spojené státy, 94304-1207
- VA Palo Alto Health Care System, Palo Alto, CA
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Kontakt:
- Daniel M Blonigen, PhD MA
- Telefonní číslo: 27828 (650) 493-5000
- E-mail: Daniel.Blonigen@va.gov
-
Vrchní vyšetřovatel:
- Daniel M. Blonigen, PhD MA
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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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.
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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 emergency department (ED) visits in the past quarter of the fiscal year.
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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 substance use disorder (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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
Ostatní jména:
|
|
Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Reach
Časové okno: 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
|
|
Adoption
Časové okno: 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. |
18 months
|
|
Implementation
Časové okno: 18 months
|
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. |
18 months
|
|
Maintenance
Časové okno: 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). |
18 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Effectiveness - Mental Health Outpatient Care
Časové okno: 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). |
6 months
|
|
Effectiveness - Substance Use Disorder Outpatient Care
Časové okno: 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
Časové okno: 6 months
|
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). |
6 months
|
|
Effectiveness - Whole Health care
Časové okno: 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
Časové okno: 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). |
6 months
|
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Effectiveness - Emergency department (ED) visits
Časové okno: 6 months
|
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
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Daniel M. Blonigen, PhD MA, VA Palo Alto Health Care System, Palo Alto, CA
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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