SuicideNCT04243330

Adaptive Implementation Intervention for VA Suicide Risk Identification Strategy

A study testing Audit and Feedback and External Facilitation in people with Suicide, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The overall objective of this national quality improvement project is to develop an adaptive implementation strategy to improve the implementation of suicide risk screening and evaluation in Veterans Health Administration ambulatory care settings (i.e., VA Risk ID). 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?: Audit and Feedback and External Facilitation
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 1 siteUnited States
Study dates: 14 Apr 2021to 15 Jun 2023
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Intervention occurs at the site/facility level. Up to 140 VHA facilities across the country will participate in the project. Sites will be allocated to various interventions based on performance (i.e., pre-determined benchmarks for adequate implementation).

Who cannot join

This is a national quality improvement project. Sites that are randomized to different intervention arms based on performance may refuse to participate in the implementation interventions.

Trial locations and contacts

1 site in 1 country.

United States1 site

Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Examining the Effectiveness of an Adaptive Implementation Intervention to Improve Uptake of the VA Suicide Risk Identification Strategy (PEC 19-303)

Read the detailed description

VA Risk ID is the largest implementation of population-based suicide risk screening and evaluation in any United States healthcare system to date. Given the considerable scope of this initiative, several strategies have been employed to support national implementation. To facilitate continuous quality improvement, ongoing evaluation of VA Risk ID and interventions to improve implementation of the three-stage screening and evaluation process are needed. This project is intended to help VHA facilities address challenges to implementing VA Risk ID to fidelity using a sequence of evidence-based implementation strategies (audit and feedback followed by audit and feedback plus external facilitation). By doing so, it will ensure that more Veterans are screened and evaluated for suicide risk, which is the basis of effective, patient-centered suicide risk management. By adapting the implementation intervention "dose" based on facility performance and monitoring implementation over time, this project will allow the program office to focus resources where and when needed the most.

Conditions: Suicide
Being tested: Audit and Feedback, External Facilitation
Keywords: prevention, implementation science
Medical subject headings: Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Audit and FeedbackBehavioural
The following components will be incorporated into the audit and feedback intervention: i) individualized facility performance data (site level), ii) frequent delivery intervals (monthly), iii) comparisons with other sites, iv) graphical and text form displays of information, v) constructive, non-punitive tone, vi) target performance or benchmark provided, and vii) specific actions or recommendations for meeting the target.
External FacilitationBehavioural
Facilitation will be conducted by a team of facilitators who will employ the facilitation process to improve uptake of VA Risk ID. Trained external facilitators will flexibly deliver the facilitation process utilizing an integrated set of implementation strategies (e.g., stakeholder engagement, identification of barriers and facilitators, education, problem solving, the use of formative data, communication, and ongoing support).

Study groups in NCT04243330
Study group	Role	What they receive
Implementation as Usual	No intervention	Implementation support consisting of clinical decision support tools, trainings, technical assistance and quality assurance to support implementation of VA Suicide Risk Identification Strategy. Available to all facilities.
Audit and Feedback	Experimental	Audit and Feedback will serve as the first stage implementation intervention for sites that do not meet the benchmark for adequate implementation following 9 months of implementation as usual. Receives: Behavioral: Audit and Feedback
External Facilitation	Experimental	Audit and Feedback plus External Facilitation will serve as the second stage implementation intervention for sites that still do not meet the benchmark for adequate implementation following 9 months of implementation as usual plus audit and feedback. Receives: Behavioral: Audit and Feedback; Behavioral: External Facilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 1
C-SSRS uptake is a site level adherence measure of the percentage of patients in ambulatory care who received a timely annual suicide risk screen (i.e., during the first encounter/visit after the annual suicide risk screen reminder was due). Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from baseline to month 8 of intervention Phase 1. Higher numbers reflect greater change in adherence from baseline to month 8 of intervention Phase 1.
Measured: Change from baseline and intervention Phase 1 month 8
Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake- Phase 1
CSRE uptake is a site level adherence measure of the percentage of patients in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from baseline to month 8 of intervention Phase 1. Higher numbers reflect greater change in adherence from baseline to month 8 of intervention Phase 1.
Measured: Change from baseline and intervention Phase 1 month 8

Secondary outcomes (4)

Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2a
C-SSRS uptake is a site level adherence measure of the percentage of patients in ambulatory care who received a timely annual suicide risk screen (i.e., during the first encounter/visit after the annual suicide risk screen reminder was due). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2.
Measured: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2a
CSRE uptake is a site level adherence measure of the percentage of patients in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2.
Measured: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2b
C-SSRS uptake is a site level adherence measure of the percentage of patients in ambulatory care who received a timely annual suicide risk screen (i.e., during the first encounter/visit after the annual suicide risk screen reminder was due). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2.
Measured: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2b
CSRE uptake is a site level adherence measure of the percentage of patients in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2. Higher numbers reflect greater change in adherence from month 9 of intervention phase 1 to month 9 of intervention phase 2.
Measured: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 202115 Jun 2023

First posted28 Jan 2020
Study start14 Apr 2021
Primary completion31 Dec 2022
Study completion15 Jun 2023

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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Sequential
Model description: Sequential Multiple Assignment Randomized Trial
Masking: None (open label)
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04243330
Sponsor's protocol ID: PEX 19-005
Other IDs: PEC 19-303
Status last verified: May 2025
First submitted: 10 Jan 2020
Last updated: 20 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bahraini NH, Matarazzo BB, Barry CN, Post EP, Forster JE, Dollar KM, Dobscha SK, Brenner LA. Protocol: examining the effectiveness of an adaptive implementation intervention to improve uptake of the VA suicide risk identification strategy: a sequential multiple assignment randomized trial. Implement Sci. 2020 Jul 22;15(1):58. doi: 10.1186/s13012-020-01019-6.
PubMed 32698812

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Suicide trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examining the Effectiveness of an Adaptive Implementation Intervention to Improve Uptake of the VA Suicide Risk Identification Strategy (PEC 19-303)
ClinicalTrials.gov ID: NCT04243330
Acronym / sponsor ID: PEX 19-005
Conditions: Suicide
Keywords: prevention, implementation science
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 14 Apr 2021 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 15 Jun 2023 (actual)
First posted: 28 Jan 2020 (actual)
Results: Posted 20 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: Sequential Multiple Assignment Randomized Trial

Arm	Type	Receives
Implementation as Usual	No intervention	–Implementation support consisting of clinical decision support tools, trainings, technical assistance and quality assurance to support implementation of VA Suicide Risk Identification Strategy. Available to all facilities.
Audit and Feedback	Experimental	Behavioral: Audit and FeedbackAudit and Feedback will serve as the first stage implementation intervention for sites that do not meet the benchmark for adequate implementation following 9 months of implementation as usual.
External Facilitation	Experimental	Behavioral: Audit and Feedback, Behavioral: External FacilitationAudit and Feedback plus External Facilitation will serve as the second stage implementation intervention for sites that still do not meet the benchmark for adequate implementation following 9 months of implementation as usual plus audit and feedback.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Intervention occurs at the site/facility level. Up to 140 VHA facilities across the country will participate in the project. Sites will be allocated to various interventions based on performance (i.e., pre-determined benchmarks for adequate implementation).

Key exclusion criteria (1 listed)

This is a national quality improvement project. Sites that are randomized to different intervention arms based on performance may refuse to participate in the implementation interventions.

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
Audit and FeedbackThe following components will be incorporated into the audit and feedback intervention: i) individualized facility performance data (site level), ii) frequent delivery intervals (monthly), iii) comparisons with other sites, iv) graphical and text form displays of information, v) constructive, non-punitive tone, vi) target performance or benchmark provided, and vii) specific actions or recommendations for meeting the target.	Behavioural	Audit and Feedback, External Facilitation
External FacilitationFacilitation will be conducted by a team of facilitators who will employ the facilitation process to improve uptake of VA Risk ID. Trained external facilitators will flexibly deliver the facilitation process utilizing an integrated set of implementation strategies (e.g., stakeholder engagement, identification of barriers and facilitators, education, problem solving, the use of formative data, communication, and ongoing support).	Behavioural	External Facilitation

Primary outcome

Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 1
Time frame: Change from baseline and intervention Phase 1 month 8
C-SSRS uptake is a site level adherence measure of the percentage of patients in ambulatory care who received a timely annual suicide risk screen (i.e., during the first encounter/visit after the annual suicide risk screen reminder was due). Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from baseline to month 8 of intervention Phase 1. Higher numbers reflect greater change in adherence from baseline to month 8 of intervention Phase 1.
Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake- Phase 1
Time frame: Change from baseline and intervention Phase 1 month 8
CSRE uptake is a site level adherence measure of the percentage of patients in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). The score is a facility adherence score. Adherence ranges from 0 to 100, higher scores reflect higher adherence. The outcome measure is reported as the change in facility adherence from baseline to month 8 of intervention Phase 1. Higher numbers reflect greater change in adherence from baseline to month 8 of intervention Phase 1.

4 secondary outcomes

Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2a
Time frame: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2a
Time frame: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2b
Time frame: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2b
Time frame: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2

Results and safety

Results posted to the registry on 20 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implementation As Usual	–	–
Audit & Feedback Responders Continue	–	–
Audit & Feedback Responders Switch	–	–
Audit & Feedback Non-Responders Continue	–	–
Audit & Feedback Non-Responders Add Facilitation	–	–
Implementation As Usual to Audit & Feedback Light	–	–

Primary outcome: Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 1

Time frame: Change from baseline and intervention Phase 1 month 8. Mean (95% Confidence Interval). Unit: change in percent adherence

Measure	Phase 1: Audit & Feedback n = NA	Phase 1: Implementation As Usual n = NA
Value	13.0 (11.9 to 14.0)	11.9 (10.9 to 13.0)

Phase 1: Audit & Feedback vs Phase 1: Implementation As Usual: Mean Difference (Net): 1.01 (95% CI -0.46 to 2.48), p = 0.18, Mixed Models Analysis

Population analysed: All sites that completed Phase 1 are included in the analysis. Sites that received Audit \& Feedback in addition to Implementation as Usual during Phase 1 are compared to sites that only received Implementation as Usual during Phase 1.

Primary outcome: Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake- Phase 1

Time frame: Change from baseline and intervention Phase 1 month 8. Mean (95% Confidence Interval). Unit: change in percent adherence

Measure	Phase 1: Audit & Feedback n = NA	Phase 1: Implementation As Usual n = NA
Value	11.0 (8.43 to 13.6)	7.45 (4.82 to 10.1)

Phase 1: Audit & Feedback vs Phase 1: Implementation As Usual: Mean Difference (Net): 3.58 (95% CI -0.11 to 7.28), p = .06, Mixed Models Analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: No adverse event data were collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Implementation As Usual	0 of 0	0 of 0
Audit & Feedback Responders Continue	0 of 0	0 of 0
Audit & Feedback Responders Switch	0 of 0	0 of 0
Audit & Feedback Non-Responders Continue	0 of 0	0 of 0
Audit & Feedback Non-Responders Add Facilitation	0 of 0	0 of 0
Implementation As Usual to Audit & Feedback Light	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Shortened study timeline due to COVID; study phases needed to be shortened potentially limiting ability to detect an impact of phase 1 intervention- audit \& feedback

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32698812Bahraini NH, Matarazzo BB, Barry CN, Post EP, Forster JE, Dollar KM, Dobscha SK, Brenner LA. Protocol: examining the effectiveness of an adaptive implementation intervention to improve uptake of the VA suicide risk identification strategy: a sequential multiple assignment randomized trial. Implement Sci. 2020 Jul 22;15(1):58. doi: 10.1186/s13012-020-01019-6.
Project DescriptionLink provided by the sponsor.
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.

Nazanin H. Bahraini, PhD principal investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Audit and Feedback and External Facilitation in people with Suicide, 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 1 inclusion and 1 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 20 May 2025. 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?

Yes. Results are posted in the registry (first posted 20 May 2025). 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?

Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 1 (time frame: Change from baseline and intervention Phase 1 month 8). The study lists 2 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 NCT04243330, 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 20 May 2025.