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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04243330
Other study ID # PEX 19-005
Secondary ID PEC 19-303
Status Completed
Phase N/A
First received
Last updated
Start date April 14, 2021
Est. completion date June 15, 2023

Study information

Verified date June 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 138
Est. completion date June 15, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
External Facilitation
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).

Locations

Country Name City State
United States Rocky Mountain Regional VA Medical Center, Aurora, CO Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety Planning Uptake 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
Other Implementation Climate Scale 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
Other Implementation Leadership Scale 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
Primary Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake C-SSRS uptake is the percentage of unique individuals 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). Change from baseline month 9 and intervention Phase 1 month 9
Primary Comprehensive Suicide Risk Evaluation (CSRE) Uptake CSRE uptake is the percentage of unique individuals in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). Change from baseline month 9 and intervention Phase 1 month 9
Secondary Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake C-SSRS uptake is the percentage of unique individuals in ambulatory care who had a positive primary screen and received the C-SSRS screener as intended (same day and by the appropriate provider). Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
Secondary Comprehensive Suicide Risk Evaluation (CSRE) Uptake CSRE uptake is the percentage of unique individuals in ambulatory care who had a positive C-SSRS screener and received the CSRE as intended (same day and by the appropriate provider). Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
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