Homeless PersonsARCHNCT01550757
Aligning Resources to Care for Homeless Veterans
A study testing Embedded Peer Mentor in people with Homeless Persons and Primary Health Care, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
"Aligning Resources to Care for Homeless Veterans" (ARCH) will study ways to best organize and deliver primary care for homeless Veterans. The investigators will assess 4 different adaptations of the PACT primary care model in a mixed methods study that includes multi-center, randomized-controlled trials of embedded… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Homeless Persons, Primary Health Care
- What is being tested?
- Embedded Peer Mentor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study population will be homeless Veterans enrolled in primary care (including both new and established patients who are homeless at the time of enrollment).
- Currently homeless to include: unsheltered; staying in an emergency shelter; in transitional/Grant and Per Diem housing; or doubled-up with a family member or friend and not paying rent.
Who cannot join
- Currently enrolled in Mental Health Intensive Case Management (MHICM) or other VA-based case/care managed program;
- Stated plans to leave the area within 6 months of enrollment;
- Unable or unwilling to provide informed consent;
- Pregnant women will because excluded because we do not wish to detract from the amount of specialty care and services they receive and need.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
About this study
Official title: Aligning Resources to Care for Homeless Veterans (ARCH)
"Aligning Resources to Care for Homeless Veterans" (ARCH) will study ways to best organize and deliver primary care for homeless Veterans. The investigators will assess 4 different adaptations of the PACT primary care model in a mixed methods study that includes multi-center, randomized-controlled trials of embedded peer-mentoring within different iterations of the PACT model, focus groups of study participants assessing satisfaction, treatment engagement and self-efficacy within the different care models and a cost-utility analysis to determine the most cost-efficient approach to organizing care for this population. Findings from this study will help determine optimal care approaches for reducing emergency department visits and acute hospitalizations, increasing patient satisfaction, and improving chronic disease management. Findings from this study will also substantively add to our understanding of health seeking behavior and the care of vulnerable/high-risk Veteran populations as well as clinical systems design. This project reflects a true "field-based study" to identify optimal and feasible approaches to patient care within our current VHA system. Finally, it will help inform pressing policy issues relevant to two identified T-21 priority areas: Ending Veteran Homelessness in 5 Years and Transforming to a Patient Centered Primary Care model.
Read the detailed description
Background:
Primary care, and specifically primary care directed to homeless Veterans represents an opportunity to engage individuals in care, address unmet health needs and facilitate receipt of services necessary to exit homelessness. However, it is unclear what the best and most cost-efficient approach is to providing this care. Past research suggests two alternative approaches to organizing and delivering primary care to homeless Veterans: (1) structurally realigned and organized care and (2) embedded peer mentoring. The overall purpose of our research is to compare and contrast outcomes from 4 different adaptations and combinations of primary care delivery to homeless Veterans within the construct of the Patient Aligned Care Team (PACT) model for primary care.
Objectives:
- To test whether a peer mentor intervention embedded in the Patient Aligned Care Team (PACT) model will be more effective than usual-care PACT or, in a separate randomized controlled trial, within a homeless-oriented PACT (H-PACT) model, in reducing emergency department use and hospitalizations, improving chronic disease management, and increasing participation in homeless programming.
- To compare clinical outcomes, service use, treatment engagement, self-efficacy, and patient satisfaction of participants in usual care-PACT with and without peer mentoring to H-PACT with and without peer mentoring.
- To determine differential costs and cost offsets associated with each PACT model adaptation in relation to care outcomes for homeless Veterans.
- To determine whether a structurally adapted health care delivery model for homeless Veterans (homeless PACT) affects treatment engagement, as measured by utilization of services over time, compared with assignment to a general population Patient Aligned Care Team or no primary care assignment.
Methods:
Substudy #1- Two multi-center Randomized Controlled Trials: The first comparing PACT to PACT+Peer Support (PACT+P); and the second comparing Homeless-oriented PACT (H-PACT) to H-PACT+Peer Support (H-PACT+P). Within each site we will conduct a 1:1 RCT of embedded peer support.
Substudy #2- A qualitative study using focus groups of study participants from each of the intervention arms to assess perceptions of care, treatment engagement, and satisfaction within each approach. These findings will be triangulated with survey data and conditional logistic regression modeling to address the question of how each model is perceived by those receiving care within it and what outcomes can be ascribed to each care approach. This submission will occur at the end of Year 2 of the project and be specific for the focus group activities.
Substudy #3- Cost-Utilization Analysis Study: We will conduct a cost-utilization analysis assessing cost offsets using CPRS, DSS, and PCMM labor mapping data to develop cost models for each care approach.
Substudy #4- VINCI Data Extraction \& Natural Language Processing: Use VINCI to analyze for PACT and H-PACT emergency department visits, including diagnosis, whether substance abuse was a factor, whether it resulted in a hospital admission, and what type of aftercare occurred (primary care follow-up, case manager telephone call note, etc.); hospital admissions (diagnosis, length of stay, and aftercare follow-up), ambulatory care utilization (primary care, mental health, specialty clinics, outpatient substance abuse treatment, and homeless programming - VRRC), including both face-to-face and remote-based care (My HealtheVet, telehealth, telephone notes), medication compliance with continuous prescriptions (i.e. insulin, antihypertensives), and chronic disease monitoring and management (blood pressure, diabetes care, hyperlipidemia in heart disease and diabetic patients). Baseline utilization (prior 6 months) of emergency department, inpatient and primary care prior to cohort tracking will be conducted to allow for post-hoc stratification of patient subgroups based on predicted risk for high use patterning.
- Conditions
- Homeless Persons, Primary Health Care
- Being tested
- Embedded Peer Mentor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embedded Peer MentorBehavioural
This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | Normal PACT Clinical Care |
| Arm 2 | Experimental | Normal PACT Clinical Care + Embedded Peer Mentor Receives: Behavioral: Embedded Peer Mentor |
| Arm 3 | No intervention | Normal Homeless Oriented PACT Clinical Care |
| Arm 4 | Experimental | Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor Receives: Behavioral: Embedded Peer Mentor |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.
A primary outcome for this study is non-acute emergency department visits.
Measured: Two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Homeless PersonsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Thomas P O'Toole, MD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550757
- Sponsor's protocol ID
- SDR 11-230
- Acronym
- ARCH
- Status last verified
- May 2017
- First submitted
- 13 Sep 2011
- Last updated
- 11 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Resnik L, Ekerholm S, Johnson EE, Ellison ML, O'Toole TP. Which Homeless Veterans Benefit From a Peer Mentor and How? J Clin Psychol. 2017 Sep;73(9):1027-1047. doi: 10.1002/jclp.22407. Epub 2016 Oct 20.
PubMed 27764527Yoon J, Lo J, Gehlert E, Johnson EE, O'Toole TP. Homeless Veterans' Use of Peer Mentors and Effects on Costs and Utilization in VA Clinics. Psychiatr Serv. 2017 Jun 1;68(6):628-631. doi: 10.1176/appi.ps.201600290. Epub 2017 Feb 1.
PubMed 28142391Van Voorhees EE, Resnik L, Johnson E, O'Toole T. Posttraumatic stress disorder and interpersonal process in homeless veterans participating in a peer mentoring intervention: Associations with program benefit. Psychol Serv. 2019 Aug;16(3):463-474. doi: 10.1037/ser0000231. Epub 2018 Jan 25.
PubMed 29369660Gundlapalli AV, Redd A, Bolton D, Vanneman ME, Carter ME, Johnson E, Samore MH, Fargo JD, O'Toole TP. Patient-aligned Care Team Engagement to Connect Veterans Experiencing Homelessness With Appropriate Health Care. Med Care. 2017 Sep;55 Suppl 9 Suppl 2:S104-S110. doi: 10.1097/MLR.0000000000000770.
PubMed 28806373
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aligning Resources to Care for Homeless Veterans (ARCH)
- ClinicalTrials.gov ID
- NCT01550757
- Acronym / sponsor ID
- ARCH / SDR 11-230
- Conditions
- Homeless Persons, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Posted 11 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Aligning Resources to Care for Homeless Veterans" (ARCH) will study ways to best organize and deliver primary care for homeless Veterans. The investigators will assess 4 different adaptations of the PACT primary care model in a mixed methods study that includes multi-center, randomized-controlled trials of embedded peer-mentoring within different iterations of the PACT model, focus groups of study participants assessing satisfaction, treatment engagement and self-efficacy within the different care models and a cost-utility analysis to determine the most cost-efficient approach to organizing care for this population. Findings from this study will help determine optimal care approaches for reducing emergency department visits and acute hospitalizations, increasing patient satisfaction, and improving chronic disease management. Findings from this study will also substantively add to our understanding of health seeking behavior and the care of vulnerable/high-risk Veteran populations as well as clinical systems design. This project reflects a true "field-based study" to identify optimal and feasible approaches to patient care within our current VHA system. Finally, it will help inform pressing policy issues relevant to two identified T-21 priority areas: Ending Veteran Homelessness in 5 Years and Transforming to a Patient Centered Primary Care model.
Detailed description
Background:
Primary care, and specifically primary care directed to homeless Veterans represents an opportunity to engage individuals in care, address unmet health needs and facilitate receipt of services necessary to exit homelessness. However, it is unclear what the best and most cost-efficient approach is to providing this care. Past research suggests two alternative approaches to organizing and delivering primary care to homeless Veterans: (1) structurally realigned and organized care and (2) embedded peer mentoring. The overall purpose of our research is to compare and contrast outcomes from 4 different adaptations and combinations of primary care delivery to homeless Veterans within the construct of the Patient Aligned Care Team (PACT) model for primary care.
Objectives:
- To test whether a peer mentor intervention embedded in the Patient Aligned Care Team (PACT) model will be more effective than usual-care PACT or, in a separate randomized controlled trial, within a homeless-oriented PACT (H-PACT) model, in reducing emergency department use and hospitalizations, improving chronic disease management, and increasing participation in homeless programming.
- To compare clinical outcomes, service use, treatment engagement, self-efficacy, and patient satisfaction of participants in usual care-PACT with and without peer mentoring to H-PACT with and without peer mentoring.
- To determine differential costs and cost offsets associated with each PACT model adaptation in relation to care outcomes for homeless Veterans.
- To determine whether a structurally adapted health care delivery model for homeless Veterans (homeless PACT) affects treatment engagement, as measured by utilization of services over time, compared with assignment to a general population Patient Aligned Care Team or no primary care assignment.
Methods:
Substudy #1- Two multi-center Randomized Controlled Trials: The first comparing PACT to PACT+Peer Support (PACT+P); and the second comparing Homeless-oriented PACT (H-PACT) to H-PACT+Peer Support (H-PACT+P). Within each site we will conduct a 1:1 RCT of embedded peer support.
Substudy #2- A qualitative study using focus groups of study participants from each of the intervention arms to assess perceptions of care, treatment engagement, and satisfaction within each approach. These findings will be triangulated with survey data and conditional logistic regression modeling to address the question of how each model is perceived by those receiving care within it and what outcomes can be ascribed to each care approach. This submission will occur at the end of Year 2 of the project and be specific for the focus group activities.
Substudy #3- Cost-Utilization Analysis Study: We will conduct a cost-utilization analysis assessing cost offsets using CPRS, DSS, and PCMM labor mapping data to develop cost models for each care approach.
Substudy #4- VINCI Data Extraction \& Natural Language Processing: Use VINCI to analyze for PACT and H-PACT emergency department visits, including diagnosis, whether substance abuse was a factor, whether it resulted in a hospital admission, and what type of aftercare occurred (primary care follow-up, case manager telephone call note, etc.); hospital admissions (diagnosis, length of stay, and aftercare follow-up), ambulatory care utilization (primary care, mental health, specialty clinics, outpatient substance abuse treatment, and homeless programming - VRRC), including both face-to-face and remote-based care (My HealtheVet, telehealth, telephone notes), medication compliance with continuous prescriptions (i.e. insulin, antihypertensives), and chronic disease monitoring and management (blood pressure, diabetes care, hyperlipidemia in heart disease and diabetic patients). Baseline utilization (prior 6 months) of emergency department, inpatient and primary care prior to cohort tracking will be conducted to allow for post-hoc stratification of patient subgroups based on predicted risk for high use patterning.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –Normal PACT Clinical Care |
| Arm 2 | Experimental | Behavioral: Embedded Peer MentorNormal PACT Clinical Care + Embedded Peer Mentor |
| Arm 3 | No intervention | –Normal Homeless Oriented PACT Clinical Care |
| Arm 4 | Experimental | Behavioral: Embedded Peer MentorNormal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The study population will be homeless Veterans enrolled in primary care (including both new and established patients who are homeless at the time of enrollment).
- Currently homeless to include: unsheltered; staying in an emergency shelter; in transitional/Grant and Per Diem housing; or doubled-up with a family member or friend and not paying rent.
Key exclusion criteria (4 listed)
- Currently enrolled in Mental Health Intensive Case Management (MHICM) or other VA-based case/care managed program;
- Stated plans to leave the area within 6 months of enrollment;
- Unable or unwilling to provide informed consent;
- Pregnant women will because excluded because we do not wish to detract from the amount of specialty care and services they receive and need.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embedded Peer MentorThis intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research. | Behavioural | Arm 2, Arm 4 |
Primary outcome
A Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.
Time frame: Two years.
A primary outcome for this study is non-acute emergency department visits.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27764527Resnik L, Ekerholm S, Johnson EE, Ellison ML, O'Toole TP. Which Homeless Veterans Benefit From a Peer Mentor and How? J Clin Psychol. 2017 Sep;73(9):1027-1047. doi: 10.1002/jclp.22407. Epub 2016 Oct 20.
- Results publication: PubMed 28142391Yoon J, Lo J, Gehlert E, Johnson EE, O'Toole TP. Homeless Veterans' Use of Peer Mentors and Effects on Costs and Utilization in VA Clinics. Psychiatr Serv. 2017 Jun 1;68(6):628-631. doi: 10.1176/appi.ps.201600290. Epub 2017 Feb 1.
- Derived from this study: PubMed 29369660Van Voorhees EE, Resnik L, Johnson E, O'Toole T. Posttraumatic stress disorder and interpersonal process in homeless veterans participating in a peer mentoring intervention: Associations with program benefit. Psychol Serv. 2019 Aug;16(3):463-474. doi: 10.1037/ser0000231. Epub 2018 Jan 25.
- Derived from this study: PubMed 28806373Gundlapalli AV, Redd A, Bolton D, Vanneman ME, Carter ME, Johnson E, Samore MH, Fargo JD, O'Toole TP. Patient-aligned Care Team Engagement to Connect Veterans Experiencing Homelessness With Appropriate Health Care. Med Care. 2017 Sep;55 Suppl 9 Suppl 2:S104-S110. doi: 10.1097/MLR.0000000000000770.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas P O'Toole, MD principal investigator
Providence VA Medical Center, Providence, RI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embedded Peer Mentor in people with Homeless Persons and Primary Health Care, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits. (time frame: Two years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01550757, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.