UH3 Pragmatic Suicide Prevention Trial
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Purpose
| Condition | Intervention |
|---|---|
| Depression Suicidal Ideation | Behavioral: Care Management Behavioral: Skills Training Behavioral: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Prevention |
| Official Title: | UH3 Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt |
- Suicide Attempts [ Time Frame: 18 Months after randomization ]EHR will be searched for any suicide attempts during the 18 months after randomization.
| Estimated Enrollment: | 16000 |
| Study Start Date: | March 2015 |
| Estimated Study Completion Date: | September 2018 |
| Estimated Primary Completion Date: | April 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Care Management
The Care Management intervention will last up to a year and includes routine outreach to assess ongoing risk of suicide attempt, and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).
|
Behavioral: Care Management
The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).
|
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Experimental: Skills Training
The Skills Training intervention will last up to a year and uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.
|
Behavioral: Skills Training
The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.
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Active Comparator: Usual Care
Those assigned to the Usual Care group will not be approached or contacted.
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Behavioral: Usual Care
Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers.
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Detailed Description:
Each week, a programmer will use Epic/Clarity data to identify adult outpatients who completed a PHQ depression questionnaire in the previous week and reported thoughts of death or self-harm "most of the days" or "nearly every day". This trial will be limited to patients receiving care from one of the three participating health systems.
Those identified will be automatically assigned to continued Usual Care or to one of two intervention programs (Care Management or Skills Training).
The Care Management intervention includes periodic outreach to assess ongoing risk of suicide attempt and as-needed care management to facilitate engagement in ongoing outpatient follow-up. Contacts will occur by secure messaging (with the option of telephone outreach for those who do not read messages). Each contact will include a request to complete a new risk assessment questionnaire (the abbreviated Columbia Suicide Severity Rating Scale used at each site) unless a risk assessment was recently documented in the medical record. Using an algorithm tested in pilot studies, the Care Manager will determine appropriate timing of follow-up and (if not already scheduled) communicate with the participant to facilitate appropriate follow-up care. Time between outreach contacts will vary from 2 weeks to 2 months, depending on the most recent risk assessment. Outreach contacts will continue up to 12 months. All outreach contacts will be documented in the Epic electronic health record in the same manner as any other mental health clinical contacts. The Care Manager(s) will be licensed mental health clinician(s) with experience in suicide risk assessment, supervised by site specific clinician investigators. A detailed protocol for the Care Management program (including sample messages) is included with this application.
The Skills Training intervention is an online program intended to teach specific skills for emotion regulation and crisis management. The content of the program is derived from Dialectical Behavior Therapy, an evidence-based psychotherapy designed for people at risk for suicide attempts. The program includes four modules or chapters, each focused on a specific skill. Each chapter includes written and video didactic instruction, video examples, in-vivo practice, and written homework exercises. The program will be supported by a Coach who will send periodic messages (via Epic secure messaging) encouraging use of the program and practice of specific skills. Coaching messages will be scheduled every 1-3 weeks during the first 3 months of the program and every 1-3 months over the following 9 months (varying according to each participant's level of participation and progress in the program). All coaching messages will be documented in the Epic electronic health record in the same manner as any other mental health clinical contacts. The Coach(es) will be licensed mental health clinician(s) supervised by site specific clinician investigators. The online program will be delivered by a secure website (GHRI's DatStat server), and participants will reach the program using encrypted personalized links sent to them via Epic secure messaging. This trial does not have open enrollment, please see the public facing website at www.NowMattersNow.org
Those assigned to Usual Care will not be contacted.
For all patients in all three intervention groups, a site programmer will extract data from the Virtual Data Warehouse to identify probable suicide attempts over 18 months following randomization.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
We propose to include all Group Health patients who:
- Complete PHQ questionnaire and respond to item 9 (regarding thoughts of death or self-harm) "more than half the days" or "nearly every day"
- Are currently enrolled in one of the three participating health systems
- Are age 18 or older
- Recent use of Epic Secure Messaging
Exclusion Criteria:
- Recorded diagnosis of dementia or developmental delay
- Previously invited to participate in the UH2 pilot trial
- Non-English speaker
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02326883
| Principal Investigator: | Greg Simon, MD. MPH | Group Health Cooperative |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Group Health Cooperative |
| ClinicalTrials.gov Identifier: | NCT02326883 History of Changes |
| Other Study ID Numbers: |
GroupHealthCoop 4UH3MH007755-02 ( U.S. NIH Grant/Contract ) UH2AT007755 ( U.S. NIH Grant/Contract ) |
| Study First Received: | December 23, 2014 |
| Last Updated: | June 8, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
|
Suicide Suicidal Ideation Self-Injurious Behavior Behavioral Symptoms |
ClinicalTrials.gov processed this record on July 17, 2017


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