- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04243330
Adaptive Implementation Intervention for VA Suicide Risk Identification Strategy
May 15, 2025 updated by: VA Office of Research and Development
Examining the Effectiveness of an Adaptive Implementation Intervention to Improve Uptake of the VA Suicide Risk Identification Strategy (PEC 19-303)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
138
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Implementation as Usual
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.
|
|
|
Experimental: Audit and Feedback
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.
|
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.
|
|
Experimental: External Facilitation
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.
|
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.
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 from baseline and intervention Phase 1 month 8
|
|
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.
|
Change from baseline and intervention Phase 1 month 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety Planning Uptake
Time Frame: Month 9 of Intervention Phase 2
|
Safety Planning uptake is the percentage of unique individuals in ambulatory care who received a safety plan following a positive suicide screen or CSRE as determined through the VA Corporate Data Warehouse (CDW).
|
Month 9 of Intervention Phase 2
|
|
Implementation Climate Scale
Time Frame: Baseline, Months 9 of Intervention Phase 1 and 2
|
18 item survey that measures the degree to which there is a strategic organizational climate supportive of evidence-based practice implementation for suicide risk screening and evaluation.
Scores range from 0 to 72 with higher scores reflecting better organizational climate for facilitating implementation of suicide risk screening and evaluation.
|
Baseline, Months 9 of Intervention Phase 1 and 2
|
|
Implementation Leadership Scale
Time Frame: Baseline, Months 9 of Intervention Phase 1 and 2
|
12 item survey that measures the degree to which facility leadership is proactive, knowledgeable, supportive, and perseverant in regard to evidence-based practice implementation for suicide risk screening and evaluation.
Scores range from 0 to 48 with higher scores reflecting greater levels of leadership support.
|
Baseline, Months 9 of Intervention Phase 1 and 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nazanin H. Bahraini, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 14, 2021
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
June 15, 2023
Study Registration Dates
First Submitted
January 10, 2020
First Submitted That Met QC Criteria
January 23, 2020
First Posted (Actual)
January 28, 2020
Study Record Updates
Last Update Posted (Estimated)
May 20, 2025
Last Update Submitted That Met QC Criteria
May 15, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEX 19-005
- PEC 19-303 (Other Grant/Funding Number: VA Quality Enhancement Research Initiative (QUERI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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