Substance Use DisorderEMPOWERNCT07309224
Employing Peer Outreach and Whole Health in Recovery for Homeless-Experienced Veterans
A study testing Employing Peer Outreach and Whole Health in Recovery (EMPOWER) in people with Substance Use Disorder and Mental Health Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder, Mental Health Disorder, Homelessness
- What is being tested?
- Employing Peer Outreach and Whole Health in Recovery (EMPOWER)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 emergency department (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 substance use disorder (SUD) diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Daniel M Blonigen, PhD MA, (650) 493-5000 ext. 27828, Daniel.Blonigen@va.gov
Daniel M. Blonigen, PhD MA
About this study
Official title: Employing Peer Outreach and Whole Health in Recovery (EMPOWER) for Homeless-Experienced Veterans: A Hybrid Type III Implementation Trial (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.
Read the 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.
- Conditions
- Substance Use Disorder, Mental Health Disorder, Homelessness
- Being tested
- Employing Peer Outreach and Whole Health in Recovery (EMPOWER)
- Keywords
- Veterans, Homeless Persons, Peer Influence, Whole Person Health, Implementation Science
- Medical subject headings
- Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Employing Peer Outreach and Whole Health in Recovery (EMPOWER)Behavioural
Also called EMPOWER
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity (LI) | Active comparator | 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. Receives: Behavioral: Employing Peer Outreach and Whole Health in Recovery (EMPOWER) |
| High-Intensity (HI) | Experimental | 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. Receives: Behavioral: Employing Peer Outreach and Whole Health in Recovery (EMPOWER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
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.
Measured: 18 months
Adoption
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.
Measured: 18 months
Implementation
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.
Measured: 18 months
Maintenance
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).
Measured: 18 months
Secondary outcomes (6)
Effectiveness - Mental Health Outpatient Care
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).
Measured: 6 months
Effectiveness - Substance Use Disorder Outpatient Care
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).
Measured: 6 months
Effectiveness - Primary Care
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).
Measured: 6 months
Effectiveness - Whole Health care
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).
Measured: 6 months
Effectiveness - Hospitalizations
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).
Measured: 6 months
Effectiveness - Emergency department (ED) visits
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisorderStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The investigators will conduct an adaptation of the multi-site hybrid III cluster randomized trial design to evaluate the implementation of EMPOWER through tailored low-intensity and high-intensity strategies. Specifically, the investigators will use a staircase design - an adaptation to stepped wedge designs (SWD). This design accommodates more flexible implementation (i.e., less burden to sites and clinicians) while at the same time offering robust statistical efficiency, given that statistical information is often strongest around time periods in the SWD when a strategy switches. For EMPOWER, of interest is the effect of switching from Low Intensity (LI - i.e., Audit and Feedback) to High Intensity (HI - i.e., Facilitation) implementation strategies; an imbalanced design will be employed in which sites will spend twice as long in HI than LI (12 months vs. 6 months, respectively).
- Masking
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel M. Blonigen, PhD MA, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309224
- Sponsor's protocol ID
- QUX 26-002
- Acronym
- EMPOWER
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blonigen DM, Hyde J, Smith J, TorresTower S, Podchiyska T, Taylor TJ, Raciborski RA, Roy SG, Midboe AM. Employing Peer Outreach and Whole Health in Recovery (EMPOWER) for homeless-experienced veterans: protocol for a hybrid type 3 implementation trial. Implement Sci. 2026 Apr 8;21(1):35. doi: 10.1186/s13012-026-01499-y.
PubMed 41952220
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Employing Peer Outreach and Whole Health in Recovery (EMPOWER) for Homeless-Experienced Veterans: A Hybrid Type III Implementation Trial (QUE 25-014)
- ClinicalTrials.gov ID
- NCT07309224
- Acronym / sponsor ID
- EMPOWER / QUX 26-002
- Conditions
- Substance Use Disorder, Mental Health Disorder, Homelessness
- Keywords
- Veterans, Homeless Persons, Peer Influence, Whole Person Health, Implementation Science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will conduct an adaptation of the multi-site hybrid III cluster randomized trial design to evaluate the implementation of EMPOWER through tailored low-intensity and high-intensity strategies. Specifically, the investigators will use a staircase design - an adaptation to stepped wedge designs (SWD). This design accommodates more flexible implementation (i.e., less burden to sites and clinicians) while at the same time offering robust statistical efficiency, given that statistical information is often strongest around time periods in the SWD when a strategy switches. For EMPOWER, of interest is the effect of switching from Low Intensity (LI - i.e., Audit and Feedback) to High Intensity (HI - i.e., Facilitation) implementation strategies; an imbalanced design will be employed in which sites will spend twice as long in HI than LI (12 months vs. 6 months, respectively).
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity (LI) | Active comparator | Behavioral: Employing Peer Outreach and Whole Health in Recovery (EMPOWER)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. |
| High-Intensity (HI) | Experimental | Behavioral: Employing Peer Outreach and Whole Health in Recovery (EMPOWER)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 emergency department (ED) visits in the past quarter of the fiscal year.
- From these reports, the investigators will identify patients at each implementation site who are
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Employing Peer Outreach and Whole Health in Recovery (EMPOWER)Also: EMPOWEREMPOWER 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. | Behavioural | High-Intensity (HI), Low-Intensity (LI) |
Primary outcome
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.
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.
Implementation
Time frame: 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.
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).
6 secondary outcomes
Effectiveness - Mental Health Outpatient Care
Time frame: 6 months
Effectiveness - Substance Use Disorder Outpatient Care
Time frame: 6 months
Effectiveness - Primary Care
Time frame: 6 months
Effectiveness - Whole Health care
Time frame: 6 months
Effectiveness - Hospitalizations
Time frame: 6 months
Effectiveness - Emergency department (ED) visits
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 41952220Blonigen DM, Hyde J, Smith J, TorresTower S, Podchiyska T, Taylor TJ, Raciborski RA, Roy SG, Midboe AM. Employing Peer Outreach and Whole Health in Recovery (EMPOWER) for homeless-experienced veterans: protocol for a hybrid type 3 implementation trial. Implement Sci. 2026 Apr 8;21(1):35. doi: 10.1186/s13012-026-01499-y.
- Individual participant dataSharing planned: No
Related trials for Substance Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
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.
Daniel M. Blonigen, PhD MA principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Employing Peer Outreach and Whole Health in Recovery (EMPOWER) in people with Substance Use Disorder and Mental Health Disorder, run by VA Office of Research and Development at 1 site 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 5 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel M Blonigen, PhD MA ((650) 493-5000 ext. 27828, Daniel.Blonigen@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: 18 months). The study lists 4 primary outcomes in all. 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 NCT07309224, which also lists 1 linked publication.
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 2 Oct 2026.