SuicideREACH VETNCT03280225
REACH VET Implementation Program Evaluation
An observational study of Suicide, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The VA's Office of Mental Health and Suicide Prevention implemented an new program to increase suicide prevention outreach for Veterans at highest risk for suicide. Using a statistical model, REACH VET, short for Recovery Engagement and Coordination for Health - Veterans Enhanced Treatment, uses information from… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- External facilitation
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Sep 2017to 31 Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will include facilities receiving virtual external facilitation for REACH VET
Who may be able to join
- VA employee at a facility receiving virtual external facilitation
- Involved in REACH VET implementation
Who cannot join
- Not a VA employee
- Not employed at a facility receiving virtual external facilitation
- Not involved in REACH VET implementation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
North Little Rock, Arkansas, 72114-1706
About this study
Official title: Risk Stratified Enhancements to Clinical Care: Targeting Care for Patients Identified Through Predictive Modeling as Being at High Risk for Suicide, With the Office of Mental Health Operations
The VA's Office of Mental Health and Suicide Prevention implemented an new program to increase suicide prevention outreach for Veterans at highest risk for suicide. Using a statistical model, REACH VET, short for Recovery Engagement and Coordination for Health - Veterans Enhanced Treatment, uses information from Veterans' health records to identify those who are at a higher risk for suicide, hospitalization, illness, or other negative outcomes. Once a Veteran is identified, his or her VA mental health or primary care provider reaches out to check on the Veteran's well-being and review their treatment plan to determine if enhanced care is needed. The goal of the current study was to evaluate the implementation of this program. The objectives of this evaluation were to evaluate how well this program is put into place using an implementation strategy called virtual external facilitation, and to collect data about the cost of the program and the strategy.
Read the detailed description
The VA's Office of Mental Health and Suicide Prevention is implemented an innovative new program to increase suicide prevention outreach and target Veterans at highest risk for suicide. Using a new predictive model, REACH VET, short for Recovery Engagement and Coordination for Health - Veterans Enhanced Treatment, analyzes existing data from Veterans' health records to identify those who are at a statistically elevated risk for suicide, hospitalization, illness, or other adverse outcomes. Once a Veteran is identified, their VA mental health or primary care provider reaches out to check on the Veteran's well-being and review their condition(s) and treatment plans to determine if enhanced care is needed.
The goal of the proposed study is to evaluate the implementation of REACH VET. The objectives of this evaluation are to:
- evaluate the implementation of REACH VET using virtual external facilitation, and
- collect preliminary data about the cost and cost offsets.
The current evaluation will examine the impact of a virtual external facilitation strategy on the implementation of REACH VET in 28 medical facilities across 7 Veteran Integrated Service Networks (VISNs) in a stepped wedge design. Primary implementation outcomes include metrics of REACH VET implementation: coordinator assignment, provider assignment, care evaluation, and attempted outreach. Qualitative interviews will be conducted with implementation facilitators, Suicide Prevention Coordinator(s), clinical leadership, and providers to identify barriers and facilitators to implementation of REACH VET and the experience of facilitation. Secondary data will be collected on the cost of the intervention and the cost of implementation strategy.
- Conditions
- Suicide
- Being tested
- External facilitation
- Keywords
- Suicide, Prevention, Implementation, Facilitation
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External facilitationOther
Also called Virtual external facilitation, facilitation, implementation facilitation
Facilitation is an evidence-based implementation strategy to support sites that have difficulty implementing innovative programs. Facilitation is a multi-faceted "process of interactive problem solving and support that occurs in the context of a recognized need for improvement and a supportive interpersonal relationship (Powell et al., 2015)." Facilitation has been used nationally across VA to implement a number of different clinical interventions. The current project will examine this minimally intensive version of implementation facilitation, virtual external facilitation.
| Study group | Role | What they receive |
|---|---|---|
| VAMC's receiving implementation support for REACH VET | This cohort consists of 28 VA Medical Centers (VAMC's) needing additional implementation support to fully implement REACH VET as identified by Veteran Integrated Service Network (VISN) leadership, and that agreed to participate. Receives: Other: External facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coordinator Assigned Post-Implementation
The average percentage of eligible Veterans across all 23 participating sites having a coordinator assigned within 2 weeks of the monthly REACH VET report being released during the 6 month post-implementation period.
Measured: 6 months after implementation was completed
Provider Assigned Post-Implementation
The average percentage of eligible Veterans across all 23 participating sites having a provider assigned within 2 weeks of the monthly REACH VET report being released during the 6 month post-implementation period .
Measured: 6 month period following implementation
Care Evaluation Performed Post-Implementation
The average percentage of eligible Veterans across all 23 participating sites receiving a care evaluation within 2 weeks of the monthly REACH VET report being released during the 6 month post-implementation period.
Measured: 6 month period following implementation
Attempted Outreach Post-Implementation
The average percentage of eligible Veterans across all 23 participating sites where outreach was attempted within 2 weeks of the monthly REACH VET report being released during the 6 month post-implementation period.
Measured: 6 month period following implementation
Secondary outcomes (1)
Organizational Readiness for Change Survey
Eligible staff at participating VA facilities were solicited to complete a modified version of the Texas Christian University Organizational Readiness for Change - Staff (TCU ORC-S). We abbreviated the original instrument to 62 items and modified text for contextual relevance. Responses were collected from 22 sites across five Veteran Integrated Service Networks (VISN). The responses were scored on ten scales: Program Needs (10 - 50 higher is preferred), Training Needs (10 - 50 higher is preferred), Pressure for Change (10 - 50 higher is preferred), Staffing (10 - 50 higher is preferred), Mission (10 - 50 higher is preferred), Cohesion (10 - 50 higher is preferred), Autonomy (10 - 50 higher is preferred), Communication (10 - 50 higher is preferred), Stress (10 - 50 lower is preferred) and Change (10 - 50 lower is preferred).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start18 Sep 2017
- Primary completion13 Mar 2020
- Study completion31 Dec 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sara J. Landes, PhD, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280225
- Sponsor's protocol ID
- SDR 16-195
- Acronym
- REACH VET
- Status last verified
- May 2023
- First submitted
- 6 Sep 2017
- Last updated
- 25 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reger MA, Luxton DD, Tucker R, Comtois KA, Keen AD, Landes SJ, Matarazzo BB, Thompson C. Implementation Methods for the Caring Contacts Suicide Prevention Intervention. Professional Psychology, Research and Practice. 2017 Oct 1; 48(5):369-377.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratified Enhancements to Clinical Care: Targeting Care for Patients Identified Through Predictive Modeling as Being at High Risk for Suicide, With the Office of Mental Health Operations
- ClinicalTrials.gov ID
- NCT03280225
- Acronym / sponsor ID
- REACH VET / SDR 16-195
- Conditions
- Suicide
- Keywords
- Suicide, Prevention, Implementation, Facilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Posted 25 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The VA's Office of Mental Health and Suicide Prevention implemented an new program to increase suicide prevention outreach for Veterans at highest risk for suicide. Using a statistical model, REACH VET, short for Recovery Engagement and Coordination for Health - Veterans Enhanced Treatment, uses information from Veterans' health records to identify those who are at a higher risk for suicide, hospitalization, illness, or other negative outcomes. Once a Veteran is identified, his or her VA mental health or primary care provider reaches out to check on the Veteran's well-being and review their treatment plan to determine if enhanced care is needed. The goal of the current study was to evaluate the implementation of this program. The objectives of this evaluation were to evaluate how well this program is put into place using an implementation strategy called virtual external facilitation, and to collect data about the cost of the program and the strategy.
Detailed description
The VA's Office of Mental Health and Suicide Prevention is implemented an innovative new program to increase suicide prevention outreach and target Veterans at highest risk for suicide. Using a new predictive model, REACH VET, short for Recovery Engagement and Coordination for Health - Veterans Enhanced Treatment, analyzes existing data from Veterans' health records to identify those who are at a statistically elevated risk for suicide, hospitalization, illness, or other adverse outcomes. Once a Veteran is identified, their VA mental health or primary care provider reaches out to check on the Veteran's well-being and review their condition(s) and treatment plans to determine if enhanced care is needed.
The goal of the proposed study is to evaluate the implementation of REACH VET. The objectives of this evaluation are to:
- evaluate the implementation of REACH VET using virtual external facilitation, and
- collect preliminary data about the cost and cost offsets.
The current evaluation will examine the impact of a virtual external facilitation strategy on the implementation of REACH VET in 28 medical facilities across 7 Veteran Integrated Service Networks (VISNs) in a stepped wedge design. Primary implementation outcomes include metrics of REACH VET implementation: coordinator assignment, provider assignment, care evaluation, and attempted outreach. Qualitative interviews will be conducted with implementation facilitators, Suicide Prevention Coordinator(s), clinical leadership, and providers to identify barriers and facilitators to implementation of REACH VET and the experience of facilitation. Secondary data will be collected on the cost of the intervention and the cost of implementation strategy.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAMC's receiving implementation support for REACH VET | – | Other: External facilitationThis cohort consists of 28 VA Medical Centers (VAMC's) needing additional implementation support to fully implement REACH VET as identified by Veteran Integrated Service Network (VISN) leadership, and that agreed to participate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include facilities receiving virtual external facilitation for REACH VET
Key inclusion criteria (2 listed)
- VA employee at a facility receiving virtual external facilitation
- Involved in REACH VET implementation
Key exclusion criteria (3 listed)
- Not a VA employee
- Not employed at a facility receiving virtual external facilitation
- Not involved in REACH VET implementation
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 |
|---|---|---|
| External facilitationAlso: Virtual external facilitation, facilitation, implementation facilitationFacilitation is an evidence-based implementation strategy to support sites that have difficulty implementing innovative programs. Facilitation is a multi-faceted "process of interactive problem solving and support that occurs in the context of a recognized need for improvement and a supportive interpersonal relationship (Powell et al., 2015)." Facilitation has been used nationally across VA to implement a number of different clinical interventions. The current project will examine this minimally intensive version of implementation facilitation, virtual external facilitation. | Other | VAMC's receiving implementation support for REACH VET |
Primary outcome
Coordinator Assigned Post-Implementation
Time frame: 6 months after implementation was completed
The average percentage of eligible Veterans across all 23 participating sites having a coordinator assigned within 2 weeks of the monthly REACH VET report being released during the 6 month post-implementation period.
Provider Assigned Post-Implementation
Time frame: 6 month period following implementation
The average percentage of eligible Veterans across all 23 participating sites having a provider assigned within 2 weeks of the monthly REACH VET report being released during the 6 month post-implementation period .
Care Evaluation Performed Post-Implementation
Time frame: 6 month period following implementation
The average percentage of eligible Veterans across all 23 participating sites receiving a care evaluation within 2 weeks of the monthly REACH VET report being released during the 6 month post-implementation period.
Attempted Outreach Post-Implementation
Time frame: 6 month period following implementation
The average percentage of eligible Veterans across all 23 participating sites where outreach was attempted within 2 weeks of the monthly REACH VET report being released during the 6 month post-implementation period.
1 secondary outcome
Organizational Readiness for Change Survey
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationReger MA, Luxton DD, Tucker R, Comtois KA, Keen AD, Landes SJ, Matarazzo BB, Thompson C. Implementation Methods for the Caring Contacts Suicide Prevention Intervention. Professional Psychology, Research and Practice. 2017 Oct 1; 48(5):369-377.
- Individual participant dataSharing planned: No
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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.
Sara J. Landes, PhD principal investigator
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide, 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 3 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 25 Jan 2024. 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 25 Jan 2024). 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?
Coordinator Assigned Post-Implementation (time frame: 6 months after implementation was completed). 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 NCT03280225, 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 25 Jan 2024.