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Adaptive Implementation Intervention for VA Suicide Risk Identification Strategy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243330
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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).

Condition or disease Intervention/treatment Phase
Suicide Behavioral: Audit and Feedback Behavioral: External Facilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential Multiple Assignment Randomized Trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Examining the Effectiveness of an Adaptive Implementation Intervention to Improve Uptake of the VA Suicide Risk Identification Strategy (PEC 19-303)
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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 6 months of implementation as usual.
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.

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 10 months of implementation as usual plus audit and feedback.
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.

Behavioral: 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).




Primary Outcome Measures :
  1. Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake [ Time Frame: Change from baseline month 6 and intervention Phase 1 month 10 ]
    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).

  2. Comprehensive Suicide Risk Evaluation (CSRE) Uptake [ Time Frame: Change from baseline month 6 and intervention Phase 1 month 10 ]
    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 :
  1. Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake [ Time Frame: Change from month 10 of intervention phase 1 and month 10 of intervention phase 2 ]
    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).

  2. Comprehensive Suicide Risk Evaluation (CSRE) Uptake [ Time Frame: Change from month 10 of intervention phase 1 and month 10 of intervention phase 2 ]
    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).


Other Outcome Measures:
  1. Safety Planning Uptake [ Time Frame: Month 10 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).

  2. Implementation Climate Scale [ Time Frame: Baseline, Months 10 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.

  3. Implementation Leadership Scale [ Time Frame: Month 10 of Intervention Phase 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243330


Contacts
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Contact: Nazanin H Bahraini, PhD (303) 399-8020 ext 5642 nazanin.bahraini@va.gov
Contact: Shannon N Archuleta, BA (720) 723-6571 Shannon.Archuleta@va.gov

Locations
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United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045
Contact: Nazanin H Bahraini, PhD    303-399-8020 ext 5642    nazanin.bahraini@va.gov   
Contact: Shannon N Archuleta, BA    (720) 723-6571    Shannon.Archuleta@va.gov   
Principal Investigator: Nazanin H. Bahraini, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Nazanin H. Bahraini, PhD Rocky Mountain Regional VA Medical Center, Aurora, CO
Additional Information:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04243330    
Other Study ID Numbers: PEX 19-005
PEC 19-303 ( Other Grant/Funding Number: VA Quality Enhancement Research Initiative (QUERI) )
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
prevention
implementation science
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms