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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05176977
Other study ID # IIR 19-187
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date January 31, 2026

Study information

Verified date January 2024
Source VA Office of Research and Development
Contact Daniel M Blonigen, PhD MA
Phone (650) 493-5000
Email Daniel.Blonigen@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Use of acute care services (e.g., hospitalizations, Emergency Department visits) contributes substantially to the cost of healthcare for Veterans. Homelessness is a robust social determinant of super utilization of acute care. The goal of this project is to test if Peer Specialists trained in Whole Health Coaching can reduce homeless Veterans' frequent use of acute care.


Description:

Ten percent of patients account for up to 70% of acute care costs. Among these "super-utilizer" patients, homelessness is a robust social determinant of acute care utilization. Through a field-based dashboard and clinical aids, the Hot Spotter Analytic program assists Patient Aligned Care Teams (PACT) with targeting and tailoring care for the highest-need homeless Veterans. However, many Veterans identified by the Analytics do not engage in supportive services that reduce risk for acute care utilization. Peer Specialists (PS) are a high-value workforce that can facilitate Veterans' engagement in care. Yet, there is a need to enhance the PS role with a structured approach that can capitalize on known facilitators of care engagement among homeless Veterans. Whole Health Coaching (WHC) is one such approach. By focusing on patients' values and goals rather than treatment of specific conditions, WHC reduces patients' stigma regarding their care needs and increases patient activation and well-being, which can increase engagement in supportive services. The goal of this project is to integrate use of Hot Spotter Analytics with Peer Specialists trained in Whole Health Coaching (PS-WHC) and evaluate whether this approach reduces homeless Veterans' frequent use of acute care. Using a Hybrid Type 1 design at the Palo Alto, Bedford, and North Little Rock VAs, the investigators will test whether receipt of PS-WHC (vs. Enhanced Usual Care; EUC) predicts (1a) lower acute care utilization, (1b) better health-related outcomes, and whether (1c) the effects of PS-WHC on 1a and 1b are mediated by increased (i) patient activation and well-being, and (ii) access to supportive services. Aim 2: Conduct a process evaluation to inform VA's potential widespread implementation of Hot Spotter Analytics + PS-WHC on PACTs. Aim 3: Conduct a Budget Impact Analysis to determine the impact on total costs of VA care due to implementing PS-WHC.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date January 31, 2026
Est. primary completion date July 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Veterans who: - are on VA's Homeless Registry, which comprises those who utilized any VA homeless programs and services in the past 2 years - are enrolled on a Patient Aligned Care Team (or "PACT") at a study site - had a hot spotter qualifying event in two or more quarters in the past year will be eligible for participation Exclusion Criteria: - Veterans who have a suicidal and/or behavioral flag in their medical record and those who are too cognitively impaired to understand the informed consent process and other study procedures will be excluded

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Peer Support-Whole Health Coaching
Participants will meet with a Peer Specialist for 18 sessions over a period of 24 weeks. The essential elements of this intervention include 1) general support provided via the core functions of a Peer Specialist and 2) a structured Whole Health Coaching curriculum.

Locations

Country Name City State
United States VA Bedford HealthCare System, Bedford, MA Bedford Massachusetts
United States Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR North Little Rock Arkansas
United States VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Blonigen D, Hyde J, McInnes DK, Yoon J, Byrne T, Ngo T, Smelson D. Integrating data analytics, peer support, and whole health coaching to improve the health outcomes of homeless veterans: Study protocol for an effectiveness-implementation trial. Contemp C — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Days of all-cause hospitalization Data on all-cause hospitalization (medical/surgical, substance use, and mental health) (bed days of care) will be obtained from the CDW Inpatient and Outpatient files. VA-paid acute care at non-VA facilities will also be searched in the Fee Basis and Program Integrity Tool (PIT) files, including "Choice" care. 9 months (post-baseline)
Secondary ED visits Data on ED visits will be obtained from the CDW Inpatient and Outpatient files. VA-paid acute care at non-VA facilities will also be searched in the Fee Basis and Program Integrity Tool (PIT) files, including "Choice" care. 9 months (post-baseline)
Secondary Substance Use The WHO-ASSIST measure will provide information on quantity and frequency of substance use, separately by drug type, in the past 30 days at each follow-up assessment. 9 months (post-baseline)
Secondary Alcohol Use Problems (AUDIT) The AUDIT is an alcohol screen that help identify patients who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). Each of the 10 items on this scale has response options from 0 to 4; scores on the outcome measure can range from 0 to 40 with higher scores indicating more alcohol use problems. 9 months (post-baseline)
Secondary Depression (PHQ-9) The Patient Health Questionnaire-9 (PHQ-9) will obtain information on changes in depression symptoms over time. The scale consists of 9 items, each answered on 4-point scale (0=not at all, 4=nearly every day). Scores on this outcome measure can range from 0 to 27, with higher scores indicating more symptoms of depression. 9 months (post-baseline)
Secondary PTSD (PCL-5) The PTSD Checklist (PCL-5) will obtain information on changes in PTSD symptoms over time. The scale consists of 20 items, each answered on a 5-point scale (0=not at all, 4=extremely). Scores on the outcome measure can range from 0 to 80 with higher scores indicating more symptoms of PTSD. 9 months (post-baseline)
Secondary Percent Days Homeless The reliable and valid Residential Timeline Followback (TLFB) interview will measure duration and frequency of homelessness (e.g., percent days homeless) in the past 90 days at baseline and each follow-up. 9 months (post-baseline)
Secondary Patient Engagement (ACE) The 21-item Altarum Consumer Engagement (ACE) Measure is a reliable and valid self-report measure of patient activation, which yields a total score. Items are answered on a 5-point scale (0=strongly disagree, 4=strongly agree). A total score is calculated ranging from 0 to 100, with higher scores indicating greater patient engagement/activation in their health care. 9 months (post-baseline)
Secondary Perceptions of Health (PROMIS-10) Global health items from the Patient Reported Outcome Measurement Information System (PROMIS) will assess perceptions of health. Comprised of 10 items, this measure will assess participants' perception of their overall health and quality of life, as well as their physical, mental, and social health. Scores 9 months (post-baseline)
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