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Effectiveness and Implementation of eScreening in Post 9/11 Transition Programs

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ClinicalTrials.gov Identifier: NCT04506164
Recruitment Status : Not yet recruiting
First Posted : August 10, 2020
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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 among Veterans. However, additional effectiveness and implementation research is warranted to evaluate the impact of eScreening within VHA. This study will address 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.

Condition or disease Intervention/treatment Phase
Depression Stress Disorders, Post-Traumatic Suicide Other: Multicomponent Implementation Strategy Other: eScreening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: his stepped-wedge trial relies on sequential roll-out to participating sites over time, while using other sites as controls until they begin implementation and facilitation. The eight participating sites will be 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 sites receive the same intervention at different times.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness and Implementation of eScreening in Post 9/11 Transition Programs
Estimated Study Start Date : June 30, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Stepped-wedge
This stepped-wedge trial relies on sequential roll-out of eScreening to participating sites over time, while using other sites as controls until they begin implementation.
Other: Multicomponent Implementation Strategy
The eScreening MCIS was developed over the past seven years and consists of: 1) eScreening software provision, 2) training, 3) RPIW, and 4) ongoing blended facilitation. The investigators developed our MCIS to address specific eScreening implementation barriers found in the investigators' prior research.

Other: eScreening
eScreening is a clinical patient self report system that allows Veterans to complete clinical reminders and other self report screens using a secure connection from any internet connected device.




Primary Outcome Measures :
  1. Change in rate of screening completion [ Time Frame: baseline (6-18months), post (18-27months), and followup (27-36months). ]
    Rate of screening completion will be calculated using medical record data from Veterans who enroll for care during the 3 months prior to the above time points. Rate of completed PC-PTSD-5+I9, PHQ-2 +I9, AUDIT-C, CSSR-S, and the disposition (positive/negative screen), 3) Rate of comprehensive suicide risk evaluation (CSRE) will be used. Change in rates between screening as usual (baseline) and eScreening will be evaluated over the timepoints.

  2. Change in time to screening completion [ Time Frame: baseline (6-18months), post (18-27months), and followup (27-36months). ]
    Time to screening completion will be calculated using medical record data from Veterans who enroll for care during the 3 months prior to the above time points. Date and time of enrollment date and time of PC-PTSD-5+I9, PHQ-2 +I9, AUDIT-C, CSSR-S, and the disposition (positive/negative screen), 3) date and time they received comprehensive suicide risk evaluation (CSRE) will be used. Speed will be calculated using time from enrollment to screening (minutes, hours, days). Change in speed between screening as usual (baseline) and eScreening will be evaluated over the timepoints.


Secondary Outcome Measures :
  1. Change in rate of referral to care [ Time Frame: baseline (6-18months), post (18-27months), and followup (27-36months). ]
    Rate of referral to follow up care will be collected from using medical record data from Veterans who enroll for care during the 3 months prior to the above time points. The percent of Veterans who enrolled and screen positive on the PC-PTSD-5+I9, PHQ-2 +I9, AUDIT-C, CSSR-S and are referred to additional care will be calculated. Change in rates between screening as usual (baseline) and eScreening will be evaluated over the timepoints.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Staff inclusion criteria:

  • Direct or indirect involvement with implementation of eScreening at the site
  • Capable of informed consent

Exclusion Criteria:

Staff exclusion criteria:

  • Not involved in or directly impacted by eScreening involvement at each site

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): NCT04506164


Contacts
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Contact: James Pittman, PhD MSW (858) 552-8585 ext 7787 james.pittman@va.gov
Contact: Erin Almklov, PhD (858) 855-8585 ext 2345 erin.almklov@va.gov

Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
Contact: Gerhard H Schulteis, PhD    858-642-3657    gerhard.schulteis@va.gov   
Contact: Coralyn Ana    (858) 552-8585 ext 5980    Coralyn.Ana@va.gov   
Principal Investigator: James Pittman, PhD MSW         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: James Pittman, PhD MSW VA San Diego Healthcare System, San Diego, CA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04506164    
Other Study ID Numbers: SDR 19-443
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only data sets without individual identifiers will be generated and shared.

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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:
suicide
mental health
screening
technology
self report
veterans
Additional relevant MeSH terms:
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Suicide
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Self-Injurious Behavior