Trial Outcomes & Findings for Adaptive Implementation Intervention for VA Suicide Risk Identification Strategy (NCT NCT04243330)

Last Updated: 2025-05-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

138 participants

Primary outcome timeframe

Change from baseline and intervention Phase 1 month 8

Results posted on

2025-05-20

Participant Flow

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

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

Unit of analysis: Sites/Facilities

Participant milestones

Participant milestones
Measure	Audit & Feedback Responders Continue This arm 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.	Audit & Feedback Responders Switch This arm 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).	Audit & Feedback Non-Responders Continue This arm 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.	Audit & Feedback Non-Responders Add Facilitation This arm 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).	Implementation As Usual to Audit & Feedback Light This arm 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 Intervention STARTED	0 6	0 6	0 40	0 17	0 69
Phase 1 Intervention COMPLETED	0 6	0 6	0 40	0 17	0 69
Phase 1 Intervention NOT COMPLETED	0 0	0 0	0 0	0 0	0 0
Phase 2 Intervention STARTED	0 6	0 6	0 40	0 17	0 69
Phase 2 Intervention COMPLETED	0 6	0 6	0 38	0 17	0 66
Phase 2 Intervention NOT COMPLETED	0 0	0 0	0 2	0 0	0 3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adaptive Implementation Intervention for VA Suicide Risk Identification Strategy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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.	Audit & Feedback Responders Continue n=6 Site/Facilities 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	Audit & Feedback Responders Switch n=6 Site/Facilities 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	Audit & Feedback Non-Responders Continue n=38 Site/Facilities 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	Audit & Feedback Non-Responders Add Facilitation n=17 Site/Facilities 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	Implementation As Usual to Audit & Feedback Light n=66 Site/Facilities 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	Total n=133 Site/Facilities Total of all reporting groups
Age, Continuous	—	NA years STANDARD_DEVIATION NA • n=6 Site/Facilities	NA years STANDARD_DEVIATION NA • n=6 Site/Facilities	NA years STANDARD_DEVIATION NA • n=38 Site/Facilities	NA years STANDARD_DEVIATION NA • n=17 Site/Facilities	NA years STANDARD_DEVIATION NA • n=66 Site/Facilities	NA years STANDARD_DEVIATION NA • n=133 Site/Facilities
Sex: Female, Male Female	—	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=38 Site/Facilities	NA Site/Facilities n=17 Site/Facilities	NA Site/Facilities n=66 Site/Facilities	NA Site/Facilities n=133 Site/Facilities
Sex: Female, Male Male	—	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=38 Site/Facilities	NA Site/Facilities n=17 Site/Facilities	NA Site/Facilities n=66 Site/Facilities	NA Site/Facilities n=133 Site/Facilities
Race (NIH/OMB) American Indian or Alaska Native	—	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=38 Site/Facilities	NA Site/Facilities n=17 Site/Facilities	NA Site/Facilities n=66 Site/Facilities	NA Site/Facilities n=133 Site/Facilities
Race (NIH/OMB) Asian	—	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=38 Site/Facilities	NA Site/Facilities n=17 Site/Facilities	NA Site/Facilities n=66 Site/Facilities	NA Site/Facilities n=133 Site/Facilities
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=38 Site/Facilities	NA Site/Facilities n=17 Site/Facilities	NA Site/Facilities n=66 Site/Facilities	NA Site/Facilities n=133 Site/Facilities
Race (NIH/OMB) Black or African American	—	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=38 Site/Facilities	NA Site/Facilities n=17 Site/Facilities	NA Site/Facilities n=66 Site/Facilities	NA Site/Facilities n=133 Site/Facilities
Race (NIH/OMB) White	—	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=38 Site/Facilities	NA Site/Facilities n=17 Site/Facilities	NA Site/Facilities n=66 Site/Facilities	NA Site/Facilities n=133 Site/Facilities
Race (NIH/OMB) More than one race	—	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=38 Site/Facilities	NA Site/Facilities n=17 Site/Facilities	NA Site/Facilities n=66 Site/Facilities	NA Site/Facilities n=133 Site/Facilities
Race (NIH/OMB) Unknown or Not Reported	—	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=6 Site/Facilities	NA Site/Facilities n=38 Site/Facilities	NA Site/Facilities n=17 Site/Facilities	NA Site/Facilities n=66 Site/Facilities	NA Site/Facilities n=133 Site/Facilities
Region of Enrollment United States	—	6 Site/Facilities n=6 Site/Facilities	6 Site/Facilities n=6 Site/Facilities	38 Site/Facilities n=38 Site/Facilities	17 Site/Facilities n=17 Site/Facilities	66 Site/Facilities n=66 Site/Facilities	133 Site/Facilities n=133 Site/Facilities
Facility Complexity Facility Complexity Level 1a-1c	—	2 Site/Facilities n=6 Site/Facilities	1 Site/Facilities n=6 Site/Facilities	26 Site/Facilities n=38 Site/Facilities	13 Site/Facilities n=17 Site/Facilities	41 Site/Facilities n=66 Site/Facilities	83 Site/Facilities n=133 Site/Facilities
Facility Complexity Facility Complexity Level 2	—	1 Site/Facilities n=6 Site/Facilities	1 Site/Facilities n=6 Site/Facilities	4 Site/Facilities n=38 Site/Facilities	4 Site/Facilities n=17 Site/Facilities	12 Site/Facilities n=66 Site/Facilities	22 Site/Facilities n=133 Site/Facilities
Facility Complexity Facility Complexity Level 3	—	3 Site/Facilities n=6 Site/Facilities	4 Site/Facilities n=6 Site/Facilities	8 Site/Facilities n=38 Site/Facilities	0 Site/Facilities n=17 Site/Facilities	13 Site/Facilities n=66 Site/Facilities	28 Site/Facilities n=133 Site/Facilities

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1: Audit & Feedback n=67 Sites/Facilities This arm included sites that received audit and feedback in additional to implementation as usual during Phase 1.	Phase 1: Implementation As Usual n=66 Sites/Facilities This arm included all sites that received implementation as usual during Phase 1.
Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 1	13.0 change in percent adherence Interval 11.9 to 14.0	11.9 change in percent adherence Interval 10.9 to 13.0

PRIMARY outcome

Timeframe: Change from baseline and intervention Phase 1 month 8

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.

Outcome measures

Outcome measures
Measure	Phase 1: Audit & Feedback n=67 Sites/Facilities This arm included sites that received audit and feedback in additional to implementation as usual during Phase 1.	Phase 1: Implementation As Usual n=66 Sites/Facilities This arm included all sites that received implementation as usual during Phase 1.
Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake- Phase 1	11.0 change in percent adherence Interval 8.43 to 13.6	7.45 change in percent adherence Interval 4.82 to 10.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Phase 1: Audit & Feedback n=6 Sites/Facilities This arm included sites that received audit and feedback in additional to implementation as usual during Phase 1.	Phase 1: Implementation As Usual n=6 Sites/Facilities This arm included all sites that received implementation as usual during Phase 1.
Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2a	13.3 change in percent adherence Interval 9.0 to 17.7	11.7 change in percent adherence Interval 7.3 to 16.0

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Phase 1: Audit & Feedback n=6 Sites/Facilities This arm included sites that received audit and feedback in additional to implementation as usual during Phase 1.	Phase 1: Implementation As Usual n=6 Sites/Facilities This arm included all sites that received implementation as usual during Phase 1.
Change in Comprehensive Suicide Risk Evaluation (CSRE) Uptake-Phase 2a	6.2 change in percent adherence Interval 0.02 to 12.3	10.2 change in percent adherence Interval 4.0 to 16.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Phase 1: Audit & Feedback n=38 Sites/Facilities This arm included sites that received audit and feedback in additional to implementation as usual during Phase 1.	Phase 1: Implementation As Usual n=17 Sites/Facilities This arm included all sites that received implementation as usual during Phase 1.
Change in Columbia Suicide Severity Rating Scale Screener (C-SSRS) Uptake- Phase 2b	18.9 change in percent adherence Interval 16.8 to 21.0	23.4 change in percent adherence Interval 20.2 to 26.5

SECONDARY outcome

Timeframe: 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.

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.