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Adaptive Implementation Intervention for VA Suicide Risk Identification Strategy

Examining the Effectiveness of an Adaptive Implementation Intervention to Improve Uptake of the VA Suicide Risk Identification Strategy (PEC 19-303)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04243330
Enrollment
138
Registered
2020-01-28
Start date
2021-04-14
Completion date
2023-06-15
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

prevention, implementation science

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.

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.

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).

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Sequential Multiple Assignment Randomized Trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 1Change from baseline and intervention Phase 1 month 8C-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 in Comprehensive Suicide Risk Evaluation (CSRE) Uptake- Phase 1Change from baseline and intervention Phase 1 month 8CSRE 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.

Secondary

MeasureTime frameDescription
Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2aChange from month 9 of intervention phase 1 and month 9 of intervention phase 2C-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 in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2aChange from month 9 of intervention phase 1 and month 9 of intervention phase 2CSRE 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 in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2bChange from month 9 of intervention phase 1 and month 9 of intervention phase 2C-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 in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2bChange from month 9 of intervention phase 1 and month 9 of intervention phase 2CSRE 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.

Countries

United States

Participant flow

Recruitment details

138 VHA facilities were recruited and enrolled. Sites were allocated to different implementation strategies based on performance.

Pre-assignment details

All sites started with implementation as usual during run-in phase.

Participants by arm

ArmCount
Implementation As Usual
This group included sites that responded to implementation as usual during run-in and continued with implementation as usual throughout the trial period. There were no sites in Arm 1 as none of the facilities implemented adequately after the run-in phase.
0
Implementation As Usual
This group included sites that responded to implementation as usual during run-in and continued with implementation as usual throughout the trial period. There were no sites in Arm 1 as none of the facilities implemented adequately after the run-in phase.
0
Audit & Feedback Responders Continue
This group included sites that did not implement adequately after the run-in phase, received audit & feedback (A&F) in Phase 1, responded to A&F, and continued A&F in Phase 2. Phase 1: randomized to A&F arm Phase 2: randomized A&F arm again
0
Audit & Feedback Responders Continue
This group included sites that did not implement adequately after the run-in phase, received audit & feedback (A&F) in Phase 1, responded to A&F, and continued A&F in Phase 2. Phase 1: randomized to A&F arm Phase 2: randomized A&F arm again
6
Audit & Feedback Responders Switch
This group included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, responded to A&F and switched to A&F Light in Phase 2. (Note. IAU became A&F Light during Phase 2). Phase 1: randomized to A&F arm Phase 2: randomized A&F Light arm
0
Audit & Feedback Responders Switch
This group included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, responded to A&F and switched to A&F Light in Phase 2. (Note. IAU became A&F Light during Phase 2). Phase 1: randomized to A&F arm Phase 2: randomized A&F Light arm
6
Audit & Feedback Non-Responders Continue
This group included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, did not respond to A&F, and continued A&F in Phase 2. Phase 1: randomized to A&F arm Phase 2: randomized A&F arm again
0
Audit & Feedback Non-Responders Continue
This group included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, did not respond to A&F, and continued A&F in Phase 2. Phase 1: randomized to A&F arm Phase 2: randomized A&F arm again
38
Audit & Feedback Non-Responders Add Facilitation
This group included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, did not respond to A&F, and accepted and received A&F + External Facilitation in Phase 2. (Note. Only included sites that accepted EF). Phase 1: randomized to A&F arm Phase 2: randomized to A&F plus External Facilitation arm
0
Audit & Feedback Non-Responders Add Facilitation
This group included sites that did not implement adequately after the run-in phase, received A&F in Phase 1, did not respond to A&F, and accepted and received A&F + External Facilitation in Phase 2. (Note. Only included sites that accepted EF). Phase 1: randomized to A&F arm Phase 2: randomized to A&F plus External Facilitation arm
17
Implementation As Usual to Audit & Feedback Light
This group included sites that did not implement adequately after the run-in phase, continued with IAU in Phase 1, and received A&F Light in Phase 2. (Note. IAU became A&F Light during Phase 2) Phase 1: randomized to Implementation as Usual arm Phase 2: received implementation as usual which became A&F Light
0
Implementation As Usual to Audit & Feedback Light
This group included sites that did not implement adequately after the run-in phase, continued with IAU in Phase 1, and received A&F Light in Phase 2. (Note. IAU became A&F Light during Phase 2) Phase 1: randomized to Implementation as Usual arm Phase 2: received implementation as usual which became A&F Light
66
Total133

Baseline characteristics

CharacteristicTotalImplementation As Usual to Audit & Feedback LightAudit & Feedback Non-Responders Add FacilitationAudit & Feedback Responders SwitchAudit & Feedback Responders ContinueAudit & Feedback Non-Responders Continue
Age, ContinuousNA yearsNA yearsNA yearsNA yearsNA yearsNA years
Facility Complexity
Facility Complexity Level 1a-1c
83 Site/Facilities41 Site/Facilities13 Site/Facilities1 Site/Facilities2 Site/Facilities26 Site/Facilities
Facility Complexity
Facility Complexity Level 2
22 Site/Facilities12 Site/Facilities4 Site/Facilities1 Site/Facilities1 Site/Facilities4 Site/Facilities
Facility Complexity
Facility Complexity Level 3
28 Site/Facilities13 Site/Facilities0 Site/Facilities4 Site/Facilities3 Site/Facilities8 Site/Facilities
Race (NIH/OMB)
American Indian or Alaska Native
NA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/Facilities
Race (NIH/OMB)
Asian
NA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/Facilities
Race (NIH/OMB)
Black or African American
NA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/Facilities
Race (NIH/OMB)
More than one race
NA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/Facilities
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
NA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/Facilities
Race (NIH/OMB)
Unknown or Not Reported
NA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/Facilities
Race (NIH/OMB)
White
NA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/Facilities
Region of Enrollment
United States
133 Site/Facilities66 Site/Facilities17 Site/Facilities6 Site/Facilities6 Site/Facilities38 Site/Facilities
Sex: Female, Male
Female
NA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/Facilities
Sex: Female, Male
Male
NA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/FacilitiesNA Site/Facilities

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

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.

Time frame: Change from baseline and intervention Phase 1 month 8

Population: All sites that completed Phase 1 are included in the analysis. Sites that received Audit \& Feedback in addition to Implementation as Usual during Phase 1 are compared to sites that only received Implementation as Usual during Phase 1.

ArmMeasureValue (MEAN)
Phase 1: Audit & FeedbackChange in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 113.0 change in percent adherence
Phase 1: Implementation As UsualChange in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 111.9 change in percent adherence
p-value: 0.1895% CI: [-0.46, 2.48]Mixed Models Analysis
Primary

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.

Time frame: Change from baseline and intervention Phase 1 month 8

Population: All sites that completed Phase 1 are included in the analysis. Sites that received Audit \& Feedback in addition to Implementation as Usual during Phase 1 are compared to sites that only received Implementation as Usual during Phase 1.

ArmMeasureValue (MEAN)
Phase 1: Audit & FeedbackChange in Comprehensive Suicide Risk Evaluation (CSRE) Uptake- Phase 111.0 change in percent adherence
Phase 1: Implementation As UsualChange in Comprehensive Suicide Risk Evaluation (CSRE) Uptake- Phase 17.45 change in percent adherence
p-value: 0.0695% CI: [-0.11, 7.28]Mixed Models Analysis
Secondary

Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2a

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.

Time frame: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2

Population: Responding sites that continued to received audit \& feedback during Phase 2 are compared to responding sites that switched to audit \& feedback light during Phase 2. For Phase 2, it was pre-specified to compare only Audit \& Feedback Light to Audit and Feedback for the group of sites that responded to Audit \& Feedback during Phase 1.

ArmMeasureValue (MEAN)
Phase 1: Audit & FeedbackChange in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2a13.3 change in percent adherence
Phase 1: Implementation As UsualChange in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2a11.7 change in percent adherence
p-value: 0.695% CI: [-4.5, 7.9]Mixed Models Analysis
Secondary

Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2b

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.

Time frame: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2

Population: Nonresponding sites that received audit and feedback in Phase 2 are compared to nonresponding sites that received audit \& feedback plus external facilitation during Phase 2.

ArmMeasureValue (MEAN)
Phase 1: Audit & FeedbackChange in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2b18.9 change in percent adherence
Phase 1: Implementation As UsualChange in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2b23.4 change in percent adherence
p-value: 0.0295% CI: [-8.3, -0.67]Mixed Models Analysis
Secondary

Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2a

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.

Time frame: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2

Population: Responding sites that continued to received audit \& feedback during Phase 2 are compared to responding sites that switched to audit \& feedback light during Phase 2. For Phase 2, it was pre-specified to compare only Audit \& Feedback Light to Audit and Feedback for the group of sites that responded to Audit \& Feedback during Phase 1.

ArmMeasureValue (MEAN)
Phase 1: Audit & FeedbackChange in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2a6.2 change in percent adherence
Phase 1: Implementation As UsualChange in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2a10.2 change in percent adherence
p-value: 0.3695% CI: [-12.8, 4.7]Mixed Models Analysis
Secondary

Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2b

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.

Time frame: Change from month 9 of intervention phase 1 and month 9 of intervention phase 2

Population: Nonresponding sites that received audit and feedback in Phase 2 are compared to nonresponding sites that received audit \& feedback plus external facilitation during Phase 2.

ArmMeasureValue (MEAN)
Phase 1: Audit & FeedbackChange in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2b13.0 change in percent adherence
Phase 1: Implementation As UsualChange in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2b13.6 change in percent adherence
p-value: 0.8295% CI: [-5.5, 4.4]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026