DepressionNCT04506164
Effectiveness and Implementation of eScreening in Post 9/11 Transition Programs
A study testing eScreening and Screening As Usual in people with Depression and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Electronic screening is effective for timely detection of, and intervention for, suicidal ideation and other mental health symptoms. The VA eScreening program is a patient self-report electronic screening system that has shown promise for the efficient and effective collection of mental and physical health information… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Stress Disorders, Post-Traumatic, Suicide
- What is being tested?
- eScreening and Screening As Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Staff inclusion criteria:
- Direct or indirect involvement with implementation of eScreening at the site
- Capable of informed consent
Who cannot join
- Staff exclusion criteria:
- Not involved in or directly impacted by eScreening involvement at each site
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Electronic screening is effective for timely detection of, and intervention for, suicidal ideation and other mental health symptoms. The VA eScreening program is a patient self-report electronic screening system that has shown promise for the efficient and effective collection of mental and physical health information among Veterans. However, additional effectiveness and implementation research is warranted to evaluate the impact of eScreening within VHA. This study addresses questions of the impact of eScreening compared to screening as usual, while evaluating a multi-component implementation strategy (MCIS) for optimal enterprise rollout of eScreening in VA Transition Care Management clinics.
Read the detailed description
This mixed methods hybrid 2, effectiveness-implementation, stepped-wedge (SW) trial evaluates the effectiveness and implementation of an electronic screening program called eScreening compared to standard of care paper and/or verbal screening methods in VHA Transition Care Management (TCM) programs. eScreening is a VHA program that allows Veterans to answer self-report screening questions via an iPad connected to the VHA secure Wi-Fi. eScreening reads from and writes to the VHA EMR. The highlighted features of eScreening include: 1) the ability for Veterans to enter screening information directly without the involvement of a clinician; 2) immediate scoring of measures; 3) an editable note generated in the EMR; and 4) clinician alerts for positive mental health screens that require follow-up for suicide risk.
Aim 1 involved evaluating eScreening, compared to paper and verbal screening (Screening As Usual), guided by the RE-AIM outcomes of PRISM in 8 VHA Transition Care Management (TCM) programs, using a cluster randomized, stepped wedge design. This stepped-wedge trial relied on sequential roll-out of eScreening to participating sites over time, while using other sites as controls until they began implementation. The 8 participating sites were stratified by size (a combination of number of TCM staff and average number of post-9/11 Veterans enrolled per month) and block randomized to four step/crossover cohorts of two sites each. All step/crossover cohorts went through a 3-month pre-implementation phase which served as the Screening As Usual comparison condition, as eScreening was not yet being implemented. This phase was followed by a 9-month active implementation using our eScreening MCIS. The eScreening MCIS will began with a 3-month period that included eScreening software provision, training, RPIW, and blended facilitation followed by 6 months of ongoing blended facilitation (9 months total). After the active implementation, all sites had a 9-month sustainment period.
Below is a detailed description of each phase:
Pre-implementation phase (Screening As Usual condition): lasted 3 months during which the research team worked with the internal facilitators to: 1) gather pre-implementation information including detailed information on the processes in place for TCM screening upon enrollment ; 2) identify points of contact for iPads and other logistical needs; 3) establish communication with TCM staff and others working with the TCM staff; 4) recruit staff participants for the study; and 5) begin ongoing tracking of process data. TCM staff names, clinic names, note titles, scheduling the RPIW, and clinical reminders completed by program staff were gathered and used for subsequent development of user accounts and content customization during the implementation phase. The implementation team also provided psychoeducation to the staff on the importance of screening. During pre-implementation, TCM teams continued usual screening procedures. These involve interview or self-report, paper-based collection of post-9/11 screening measures, including the system-wide standardized assessments of depression, PTSD and alcohol use (PHQ-2, PCPTSD, and Audit-C, respectively). Patients who score positive on the PHQ-2 and PCPTSD were then administered the Columbia Suicide Severity Rating Scale (C-SSRS), which collects more information regarding risk of suicide. Veterans who are positive on C-SSRS then receive a Comprehensive Suicide Risk Evaluation and are referred for appropriate follow-up. A detailed description and flow map of the current screening process at each site were developed by the external facilitator (research team) and internal facilitator (site staff) with information from the TCM staff prior to the implementation phase.
eScreening Implementation phase: during this 9 month phase, the MCIS was used to implement eScreening. This strategy consisted of eScreening software provision, user training, RPIW, and facilitation. Virtual and asynchronous eScreening training was provided and included a 1-hour instructional PowerPoint presented by the external facilitator. The PowerPoint was followed by an hour of tutorial videos showing all steps of (creating assessments, adding Veterans, saving to VistA, searching for assessments, creating scheduled appointment assessments, accessing reports). Hands-on training for users was available in group format or individually by the training staff as requested by the TCM site staff. Additional training materials could be accessed via the eScreening Pulse site which include a series of quick guides to address eScreening customization, assessment set-up and dashboard use. Frequently asked questions were also available on the Pulse site. The 3-day RPIW was facilitated virtually by the external facilitator with assistance from the onsite internal facilitator and included the TCM team, related staff (i.e., medical support staff, clerks), and other site stakeholders. The first day of the process trained participants in the RPIW principles and introduced a summary of the information gathered in the Pre-Implementation Phase, including a graphic of the current state process map which was then refined and finalized. The second day consisted of collective efforts to map a targeted future state, conduct a gap analysis, and identify relevant factors and barriers unique to the site. The third day was dedicated to the repetition of action planning, execution, and reevaluation to finalize the targeted state and identify clinically meaningful goals for improvement. Using a Plan-Do-Study-Act (PDSA) framework, the plans to achieve the target state are enacted with a detailed plan that includes who, what, when for each step in the plan. Due to the flexibility of eScreening and the implementation strategy, each TCM program could choose to integrate eScreening into their workflow based on the specific needs of their program, available resources, and other factors. This was followed by 6 months of ongoing facilitation, in which the primary external facilitator from the eScreening team worked with the site internal facilitator to schedule meetings, training sessions, and phone calls. The external facilitator was the main point of contact for implementation-related questions.
Sustainment Phase: this was a 9-month phase that did not involve any active implementation.
Throughout all study phases, patient level data was collected from EMR (for which the investigators had a HIPPA waiver), and no Veterans directly participated. EMR data was extracted from the Corporate Data Warehouse (CDW) database. EMR data consisted of 1) the number of Veterans that enrolled in the healthcare system and the date and time they enrolled, 2) the date and time that they received PC-PTSD-5, PHQ-2, AUDIT-C, CSSR-S, and the disposition (positive/negative screen), 3) date and time they received comprehensive suicide risk evaluation (CSRE), and 4) mental health care referrals. These data were used to calculate the overall rate of screening completion and referral to mental health care and the average length of time to screening completion.
To test Aim1 - whether the likelihood of receiving mental health screening differed between eScreening and Screening As Usual (Reach aim), we conducted logistic regression analyses comparing the proportion of newly enrolled veterans who received PTSD, PHQ-9, AUDIT, and CSSRS screening during the eScreening implementation phase and the sustainment phase to the pre-implementation/Screening As Usual phase. To test whether the number of days it took to receive mental health screening differed between eScreening and Screening As Usual (Effectiveness aim), we conducted Cox regression analyses comparing the number of days from enrollment to PTSD, PHQ-9, AUDIT, and CSSRS screening among newly enrolled veterans during the eScreening implementation phase and the sustainment phase to the pre-implementation/Screening As Usual phase. Finally, to test whether the likelihood of receiving a mental health consult request differed between eScreening and Screening As Usual (Effectiveness aim), we conducted logistic regression analyses comparing the proportion of newly enrolled veterans who received PTSD, PHQ-9, AUDIT, and CSSRS screening within 30 days of enrollment and screened positive for PTSD, depression, suicidality, or substance use during the eScreening implementation phase and the sustainment phase to the pre-implementation/Screening As Usual phase.
Aim 2 of this study involved evaluating the feasibility, acceptability, and potential impact of the MCIS, guided by the RE-AIM outcomes of PRISM, adoption, implementation, and maintenance using mixed methods. In addition to the patient level data above, Transition Care Management staff at each of the 8 VHA sites who had direct involvement with the implementation of eScreening were asked to take part in this research. These participants completed a quantitative survey called the "PRSIM Contextual Survey Instrument" (PSCI) focused on assessing the feasibility and acceptability of eScreening; and factors affecting adoption, implementation, and sustained use of eScreening. The PCSI included 29 items across the six PRISM domains: Organizational Perspective, Patient Perspective, Implementation and Sustainability Infrastructure, Organizational Characteristics, Patient Characteristics, and External Environment. Items were rated on a 5-point Likert scale. Surveys were administered at three phases (pre-implementation, implementation, and sustainment). Investigators examined staff responses on the PCSI surveys by implementation phase (pre-implementation, implementation, and sustainment) using non-parametric tests.
- Conditions
- Depression, Stress Disorders, Post-Traumatic, Suicide
- Being tested
- eScreening, Screening As Usual
- Keywords
- suicide, mental health, screening, technology, self report, veterans
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Suicide, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eScreeningOther
eScreening is a clinical patient self report system that allows Veterans to complete self report screens, including assessments of depression, PTSD and alcohol use, using a secure connection from any internet connected device.
Screening As UsualOther
Assessment of depression, PTSD and alcohol use using verbal and paper-based screening methods.
| Study group | Role | What they receive |
|---|---|---|
| Screening As Usual/Pre-implementation | Active comparator | During this 3 month pre-implementation period, usual screening methods were used (i.e., verbal and paper-based screening). Receives: Other: Screening As Usual |
| eScreening Implementation | Experimental | During this 9 month active implementation phase, eScreening was implemented using the MCIS. Receives: Other: eScreening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Rate of PTSD Screening During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Proportion of newly enrolled Veterans who received PTSD screening (i.e., The Primary Care PTSD Screen for DSM-5 [PC-PTSD-5]) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Measured: within 30 days of enrollment at the VA study site during each phase
Compare Rate of Depression (PHQ-2) Screening During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Proportion of newly enrolled Veterans who received depression screening (Patient Health Questionnaire-2; PHQ-2) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Measured: within 30 days of enrollment at the VA study site during each phase
Compare Rate of Alcohol Screening (AUDIT) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Proportion of newly enrolled Veterans who received alcohol screening (AUDIT) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Measured: within 30 days of enrollment at the VA study site during each phase
Compare Rate of Suicide Screening (CSSRS) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Proportion of newly enrolled Veterans who received suicide screening (Columbia-Suicide Severity Rating Scale; CSSRS) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Measured: within 30 days of enrollment at the VA study site during each phase.
Time to PTSD Screening (PC-PTSD-5) Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Number of days to receive PTSD screening (PC-PTSD-5) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Measured: within 30 days of enrollment at the VA study site during each phase.
Time to Depression (PHQ-2) Screening Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Number of days to depression screening (PHQ-2) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Measured: within 30 days of enrollment at the VA study site during each phase.
Time to Alcohol Screening (AUDIT) Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Number of days to alcohol screening (AUDIT) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Measured: within 30 days of enrollment at the VA study site during each phase.
Time to Suicide Screening (CSSRS) Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Number of days to suicide screening (CSSRS) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Measured: within 30 days of enrollment at the VA study site during each phase.
Change in Rate of Referral to Mental Health Care Following Positive PTSD Screen (PC-PTSD-5) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation.
Change in rate of referral to mental health follow up care (BHIP) following a positive PTSD screen (PC-PTSD-5) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase.
Measured: 30 days from the date the screener was administered during each phase.
Change in Rate of Referral to Mental Health Care Following Positive Depression Screen (PHQ-2) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
change in rate of referral to mental health follow up care (BHIP) following a positive depression (PHQ-2) screen during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase.
Measured: 30 days from the date the screener was administered during each phase.
Change in Rate of Referral to Substance Use Treatment Following Positive Alcohol Screen (AUDIT) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
change in rate of referral to substance use treatment following a positive alcohol screen (AUDIT) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase.
Measured: 30 days from the date the screener was administered during each phase
Secondary outcomes (1)
PRISM Contextual Survey Instrument (PCSI)
Staff survey responses on the Patient Perspectives domain of the PRISM Contextual Survey Instrument (PCSI). The PCSI includes 29 items rated on a 5-point Likert scale, where 1 = strongly disagree and 5= strongly agree; thus higher scores represent more positive perspectives.
Measured: Surveys were administered within 60 days of initiating each phase: pre-implementation, implementation, and sustainment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start18 Jun 2021
- Primary completion29 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This project primarily examined the effectiveness of an electronic health screening technology (eScreening) compared to Screening As Usual (paper/verbal screening) in eight VHA sites. eScreening was implemented at each site using a multicomponent implementation strategy (MCIS) composed of software provisioning, a 3-day Lean Six Sigma Rapid Process Improvement Workshop (RPIW), user training, and ongoing facilitation. We evaluated the impact of eScreening on the proportion of newly enrolling Veterans being screened, time from enrollment to screening, and referral to needed care by comparing data collected during the pre-implementation Screening As Usual phase with data collected during the eScreening implementation.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James Pittman, PhD MSW, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506164
- Sponsor's protocol ID
- SDR 19-443
- Other IDs
- 1I01HX003079-01A1
- Status last verified
- Jan 2026
- First submitted
- 5 Aug 2020
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only data sets without individual identifiers will be generated and shared.
Publications
Pittman JOE, Lindamer L, Afari N, Depp C, Villodas M, Hamilton A, Kim B, Mor MK, Almklov E, Gault J, Rabin B. Implementing eScreening for suicide prevention in VA post-9/11 transition programs using a stepped-wedge, mixed-method, hybrid type-II implementation trial: a study protocol. Implement Sci Commun. 2021 Apr 29;2(1):46. doi: 10.1186/s43058-021-00142-9.
PubMed 33926577
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of eScreening in Post 9/11 Transition Programs
- ClinicalTrials.gov ID
- NCT04506164
- Acronym / sponsor ID
- SDR 19-443
- Conditions
- Depression, Stress Disorders, Post-Traumatic, Suicide
- Keywords
- suicide, mental health, screening, technology, self report, veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electronic screening is effective for timely detection of, and intervention for, suicidal ideation and other mental health symptoms. The VA eScreening program is a patient self-report electronic screening system that has shown promise for the efficient and effective collection of mental and physical health information among Veterans. However, additional effectiveness and implementation research is warranted to evaluate the impact of eScreening within VHA. This study addresses questions of the impact of eScreening compared to screening as usual, while evaluating a multi-component implementation strategy (MCIS) for optimal enterprise rollout of eScreening in VA Transition Care Management clinics.
Detailed description
This mixed methods hybrid 2, effectiveness-implementation, stepped-wedge (SW) trial evaluates the effectiveness and implementation of an electronic screening program called eScreening compared to standard of care paper and/or verbal screening methods in VHA Transition Care Management (TCM) programs. eScreening is a VHA program that allows Veterans to answer self-report screening questions via an iPad connected to the VHA secure Wi-Fi. eScreening reads from and writes to the VHA EMR. The highlighted features of eScreening include: 1) the ability for Veterans to enter screening information directly without the involvement of a clinician; 2) immediate scoring of measures; 3) an editable note generated in the EMR; and 4) clinician alerts for positive mental health screens that require follow-up for suicide risk.
Aim 1 involved evaluating eScreening, compared to paper and verbal screening (Screening As Usual), guided by the RE-AIM outcomes of PRISM in 8 VHA Transition Care Management (TCM) programs, using a cluster randomized, stepped wedge design. This stepped-wedge trial relied on sequential roll-out of eScreening to participating sites over time, while using other sites as controls until they began implementation. The 8 participating sites were stratified by size (a combination of number of TCM staff and average number of post-9/11 Veterans enrolled per month) and block randomized to four step/crossover cohorts of two sites each. All step/crossover cohorts went through a 3-month pre-implementation phase which served as the Screening As Usual comparison condition, as eScreening was not yet being implemented. This phase was followed by a 9-month active implementation using our eScreening MCIS. The eScreening MCIS will began with a 3-month period that included eScreening software provision, training, RPIW, and blended facilitation followed by 6 months of ongoing blended facilitation (9 months total). After the active implementation, all sites had a 9-month sustainment period.
Below is a detailed description of each phase:
Pre-implementation phase (Screening As Usual condition): lasted 3 months during which the research team worked with the internal facilitators to: 1) gather pre-implementation information including detailed information on the processes in place for TCM screening upon enrollment ; 2) identify points of contact for iPads and other logistical needs; 3) establish communication with TCM staff and others working with the TCM staff; 4) recruit staff participants for the study; and 5) begin ongoing tracking of process data. TCM staff names, clinic names, note titles, scheduling the RPIW, and clinical reminders completed by program staff were gathered and used for subsequent development of user accounts and content customization during the implementation phase. The implementation team also provided psychoeducation to the staff on the importance of screening. During pre-implementation, TCM teams continued usual screening procedures. These involve interview or self-report, paper-based collection of post-9/11 screening measures, including the system-wide standardized assessments of depression, PTSD and alcohol use (PHQ-2, PCPTSD, and Audit-C, respectively). Patients who score positive on the PHQ-2 and PCPTSD were then administered the Columbia Suicide Severity Rating Scale (C-SSRS), which collects more information regarding risk of suicide. Veterans who are positive on C-SSRS then receive a Comprehensive Suicide Risk Evaluation and are referred for appropriate follow-up. A detailed description and flow map of the current screening process at each site were developed by the external facilitator (research team) and internal facilitator (site staff) with information from the TCM staff prior to the implementation phase.
eScreening Implementation phase: during this 9 month phase, the MCIS was used to implement eScreening. This strategy consisted of eScreening software provision, user training, RPIW, and facilitation. Virtual and asynchronous eScreening training was provided and included a 1-hour instructional PowerPoint presented by the external facilitator. The PowerPoint was followed by an hour of tutorial videos showing all steps of (creating assessments, adding Veterans, saving to VistA, searching for assessments, creating scheduled appointment assessments, accessing reports). Hands-on training for users was available in group format or individually by the training staff as requested by the TCM site staff. Additional training materials could be accessed via the eScreening Pulse site which include a series of quick guides to address eScreening customization, assessment set-up and dashboard use. Frequently asked questions were also available on the Pulse site. The 3-day RPIW was facilitated virtually by the external facilitator with assistance from the onsite internal facilitator and included the TCM team, related staff (i.e., medical support staff, clerks), and other site stakeholders. The first day of the process trained participants in the RPIW principles and introduced a summary of the information gathered in the Pre-Implementation Phase, including a graphic of the current state process map which was then refined and finalized. The second day consisted of collective efforts to map a targeted future state, conduct a gap analysis, and identify relevant factors and barriers unique to the site. The third day was dedicated to the repetition of action planning, execution, and reevaluation to finalize the targeted state and identify clinically meaningful goals for improvement. Using a Plan-Do-Study-Act (PDSA) framework, the plans to achieve the target state are enacted with a detailed plan that includes who, what, when for each step in the plan. Due to the flexibility of eScreening and the implementation strategy, each TCM program could choose to integrate eScreening into their workflow based on the specific needs of their program, available resources, and other factors. This was followed by 6 months of ongoing facilitation, in which the primary external facilitator from the eScreening team worked with the site internal facilitator to schedule meetings, training sessions, and phone calls. The external facilitator was the main point of contact for implementation-related questions.
Sustainment Phase: this was a 9-month phase that did not involve any active implementation.
Throughout all study phases, patient level data was collected from EMR (for which the investigators had a HIPPA waiver), and no Veterans directly participated. EMR data was extracted from the Corporate Data Warehouse (CDW) database. EMR data consisted of 1) the number of Veterans that enrolled in the healthcare system and the date and time they enrolled, 2) the date and time that they received PC-PTSD-5, PHQ-2, AUDIT-C, CSSR-S, and the disposition (positive/negative screen), 3) date and time they received comprehensive suicide risk evaluation (CSRE), and 4) mental health care referrals. These data were used to calculate the overall rate of screening completion and referral to mental health care and the average length of time to screening completion.
To test Aim1 - whether the likelihood of receiving mental health screening differed between eScreening and Screening As Usual (Reach aim), we conducted logistic regression analyses comparing the proportion of newly enrolled veterans who received PTSD, PHQ-9, AUDIT, and CSSRS screening during the eScreening implementation phase and the sustainment phase to the pre-implementation/Screening As Usual phase. To test whether the number of days it took to receive mental health screening differed between eScreening and Screening As Usual (Effectiveness aim), we conducted Cox regression analyses comparing the number of days from enrollment to PTSD, PHQ-9, AUDIT, and CSSRS screening among newly enrolled veterans during the eScreening implementation phase and the sustainment phase to the pre-implementation/Screening As Usual phase. Finally, to test whether the likelihood of receiving a mental health consult request differed between eScreening and Screening As Usual (Effectiveness aim), we conducted logistic regression analyses comparing the proportion of newly enrolled veterans who received PTSD, PHQ-9, AUDIT, and CSSRS screening within 30 days of enrollment and screened positive for PTSD, depression, suicidality, or substance use during the eScreening implementation phase and the sustainment phase to the pre-implementation/Screening As Usual phase.
Aim 2 of this study involved evaluating the feasibility, acceptability, and potential impact of the MCIS, guided by the RE-AIM outcomes of PRISM, adoption, implementation, and maintenance using mixed methods. In addition to the patient level data above, Transition Care Management staff at each of the 8 VHA sites who had direct involvement with the implementation of eScreening were asked to take part in this research. These participants completed a quantitative survey called the "PRSIM Contextual Survey Instrument" (PSCI) focused on assessing the feasibility and acceptability of eScreening; and factors affecting adoption, implementation, and sustained use of eScreening. The PCSI included 29 items across the six PRISM domains: Organizational Perspective, Patient Perspective, Implementation and Sustainability Infrastructure, Organizational Characteristics, Patient Characteristics, and External Environment. Items were rated on a 5-point Likert scale. Surveys were administered at three phases (pre-implementation, implementation, and sustainment). Investigators examined staff responses on the PCSI surveys by implementation phase (pre-implementation, implementation, and sustainment) using non-parametric tests.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This project primarily examined the effectiveness of an electronic health screening technology (eScreening) compared to Screening As Usual (paper/verbal screening) in eight VHA sites. eScreening was implemented at each site using a multicomponent implementation strategy (MCIS) composed of software provisioning, a 3-day Lean Six Sigma Rapid Process Improvement Workshop (RPIW), user training, and ongoing facilitation. We evaluated the impact of eScreening on the proportion of newly enrolling Veterans being screened, time from enrollment to screening, and referral to needed care by comparing data collected during the pre-implementation Screening As Usual phase with data collected during the eScreening implementation.
| Arm | Type | Receives |
|---|---|---|
| Screening As Usual/Pre-implementation | Active comparator | Other: Screening As UsualDuring this 3 month pre-implementation period, usual screening methods were used (i.e., verbal and paper-based screening). |
| eScreening Implementation | Experimental | Other: eScreeningDuring this 9 month active implementation phase, eScreening was implemented using the MCIS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Direct or indirect involvement with implementation of eScreening at the site
- Capable of informed consent
Key exclusion criteria (2 listed)
- Not involved in or directly impacted by eScreening involvement at each site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eScreeningeScreening is a clinical patient self report system that allows Veterans to complete self report screens, including assessments of depression, PTSD and alcohol use, using a secure connection from any internet connected device. | Other | eScreening Implementation |
| Screening As UsualAssessment of depression, PTSD and alcohol use using verbal and paper-based screening methods. | Other | Screening As Usual/Pre-implementation |
Primary outcome
Compare Rate of PTSD Screening During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Time frame: within 30 days of enrollment at the VA study site during each phase
Proportion of newly enrolled Veterans who received PTSD screening (i.e., The Primary Care PTSD Screen for DSM-5 [PC-PTSD-5]) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Compare Rate of Depression (PHQ-2) Screening During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Time frame: within 30 days of enrollment at the VA study site during each phase
Proportion of newly enrolled Veterans who received depression screening (Patient Health Questionnaire-2; PHQ-2) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Compare Rate of Alcohol Screening (AUDIT) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Time frame: within 30 days of enrollment at the VA study site during each phase
Proportion of newly enrolled Veterans who received alcohol screening (AUDIT) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Compare Rate of Suicide Screening (CSSRS) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Time frame: within 30 days of enrollment at the VA study site during each phase.
Proportion of newly enrolled Veterans who received suicide screening (Columbia-Suicide Severity Rating Scale; CSSRS) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the rate of screening (i.e., the proportion of Veterans who received the screening measure versus those who did not) during each phase, and then compared the proportion of Veterans who received screening during the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Time to PTSD Screening (PC-PTSD-5) Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Time frame: within 30 days of enrollment at the VA study site during each phase.
Number of days to receive PTSD screening (PC-PTSD-5) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Time to Depression (PHQ-2) Screening Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Time frame: within 30 days of enrollment at the VA study site during each phase.
Number of days to depression screening (PHQ-2) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Time to Alcohol Screening (AUDIT) Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Time frame: within 30 days of enrollment at the VA study site during each phase.
Number of days to alcohol screening (AUDIT) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Time to Suicide Screening (CSSRS) Completion During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Time frame: within 30 days of enrollment at the VA study site during each phase.
Number of days to suicide screening (CSSRS) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase. For this outcome, we calculated the time to screening (in days) during each phase, and then compared the time to screening for the eScreening implementation and sustainment phases vs. screening as usual/pre-implementation phase.
Change in Rate of Referral to Mental Health Care Following Positive PTSD Screen (PC-PTSD-5) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation.
Time frame: 30 days from the date the screener was administered during each phase.
Change in rate of referral to mental health follow up care (BHIP) following a positive PTSD screen (PC-PTSD-5) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase.
Change in Rate of Referral to Mental Health Care Following Positive Depression Screen (PHQ-2) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Time frame: 30 days from the date the screener was administered during each phase.
change in rate of referral to mental health follow up care (BHIP) following a positive depression (PHQ-2) screen during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase.
Change in Rate of Referral to Substance Use Treatment Following Positive Alcohol Screen (AUDIT) During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation
Time frame: 30 days from the date the screener was administered during each phase
change in rate of referral to substance use treatment following a positive alcohol screen (AUDIT) during the eScreening implementation and sustainment phases compared to the screening as usual/pre-implementation phase.
1 secondary outcome
PRISM Contextual Survey Instrument (PCSI)
Time frame: Surveys were administered within 60 days of initiating each phase: pre-implementation, implementation, and sustainment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33926577Pittman JOE, Lindamer L, Afari N, Depp C, Villodas M, Hamilton A, Kim B, Mor MK, Almklov E, Gault J, Rabin B. Implementing eScreening for suicide prevention in VA post-9/11 transition programs using a stepped-wedge, mixed-method, hybrid type-II implementation trial: a study protocol. Implement Sci Commun. 2021 Apr 29;2(1):46. doi: 10.1186/s43058-021-00142-9.
- Individual participant dataSharing planned: No. Only data sets without individual identifiers will be generated and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Pittman, PhD MSW principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eScreening and Screening As Usual in people with Depression and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Rate of PTSD Screening During eScreening Implementation and Sustainment vs. Screening as Usual/Pre-implementation (time frame: within 30 days of enrollment at the VA study site during each phase). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04506164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.