NCT04243330

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 14, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 20, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

January 10, 2020

Results QC Date

January 17, 2025

Last Update Submit

May 15, 2025

Conditions

Keywords

preventionimplementation science

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    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

    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

    Change from month 9 of intervention phase 1 and month 9 of intervention phase 2

Study Arms (3)

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.

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.

Behavioral: Audit and FeedbackBehavioral: External Facilitation

Interventions

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.

Audit and FeedbackExternal 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).

External Facilitation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Limitations and Caveats

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

Results Point of Contact

Title
Nazanin Bahraini, PhD
Organization
VA Rocky Mountain MIRECC

Study Officials

  • Nazanin H. Bahraini, PhD

    Rocky Mountain Regional VA Medical Center, Aurora, CO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Sequential Multiple Assignment Randomized Trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 28, 2020

Study Start

April 14, 2021

Primary Completion

December 31, 2022

Study Completion

June 15, 2023

Last Updated

May 20, 2025

Results First Posted

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations