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Adaptive Implementation Intervention for VA Suicide Risk Identification Strategy

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audit and Feedback
External Facilitation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Suicide focused on measuring prevention, implementation science

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Implementation as Usual

Audit and Feedback

External Facilitation

Arm Description

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 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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
January 10, 2020
Last Updated
June 27, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04243330
Brief Title
Adaptive Implementation Intervention for VA Suicide Risk Identification Strategy
Official Title
Examining the Effectiveness of an Adaptive Implementation Intervention to Improve Uptake of the VA Suicide Risk Identification Strategy (PEC 19-303)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
prevention, implementation science

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Sequential Multiple Assignment Randomized Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implementation as Usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Audit and Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
External Facilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Audit and Feedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
External Facilitation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake
Description
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).
Time Frame
Change from baseline month 9 and intervention Phase 1 month 9
Title
Comprehensive Suicide Risk Evaluation (CSRE) Uptake
Description
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).
Time Frame
Change from baseline month 9 and intervention Phase 1 month 9
Secondary Outcome Measure Information:
Title
Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake
Description
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).
Time Frame
Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
Title
Comprehensive Suicide Risk Evaluation (CSRE) Uptake
Description
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).
Time Frame
Change from month 9 of intervention phase 1 and month 9 of intervention phase 2
Other Pre-specified Outcome Measures:
Title
Safety Planning Uptake
Description
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).
Time Frame
Month 9 of Intervention Phase 2
Title
Implementation Climate Scale
Description
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.
Time Frame
Baseline, Months 9 of Intervention Phase 1 and 2
Title
Implementation Leadership Scale
Description
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.
Time Frame
Baseline, Months 9 of Intervention Phase 1 and 2

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazanin H. Bahraini, PhD
Organizational Affiliation
Rocky Mountain Regional VA Medical Center, Aurora, CO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32698812
Citation
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.
Results Reference
derived
Links:
URL
https://www.queri.research.va.gov/national_partnered_evaluations/suicide_identification.cfm
Description
Project Description

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Adaptive Implementation Intervention for VA Suicide Risk Identification Strategy

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