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UH3 Pragmatic Suicide Prevention Trial (SPOT)

Primary Purpose

Depression, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Care Management
Skills Training
Usual Care
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

We propose to include all patients at the participating sites 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 four 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Care Management

    Skills Training

    Usual Care

    Arm Description

    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).

    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.

    Those assigned to the Usual Care group will not be approached or contacted.

    Outcomes

    Primary Outcome Measures

    Time to Fatal or Non-fatal Suicide Attempt or Self-Harm
    Electronic health records and insurance claims data will be searched for any nonfatal suicide attempts or self-harm during the 18 months after randomization. Fatal suicide attempts will be identified from state mortality data.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 23, 2014
    Last Updated
    September 21, 2021
    Sponsor
    Kaiser Permanente
    Collaborators
    National Institute of Mental Health (NIMH), HealthPartners Institute, National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02326883
    Brief Title
    UH3 Pragmatic Suicide Prevention Trial
    Acronym
    SPOT
    Official Title
    UH3 Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (Actual)
    Primary Completion Date
    April 2020 (Actual)
    Study Completion Date
    April 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaiser Permanente
    Collaborators
    National Institute of Mental Health (NIMH), HealthPartners Institute, National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This pragmatic clinical trial will evaluate the effectiveness of two population-based outreach programs for preventing suicide attempts among patients identified as at-risk. The study will be conducted at Kaiser Permanente (KP) Washington (the lead site) and at HealthPartners, KP Colorado and KP Northwest. Electronic health records will be used to identify outpatients aged 18 or older who respond to a routinely administered PHQ depression questionnaire by reporting 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 four participating health systems. Eligible patients will be automatically assigned to continue in usual care (1/3) or to either of the two intervention programs (1/3 each). 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. Both intervention programs involve outreach by Epic secure messaging (with optional telephone outreach for those not reading messages). 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 treatment by primary and behavioral health care providers using Epic Staff Messaging (or telephone contacts if necessary). 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. Each intervention continues for up to one year. In all three groups (Usual Care, Care Management, and Skills Training) virtual data warehouse data will be used to identify likely suicide attempts over 18 months following randomization. Analyses will compare risk of suicide attempt among all those randomized, regardless of response to the initial invitation or level of participation in the intervention programs. Comparison of all those randomized is the only scientifically valid method for assessing the overall impact of either program on population-level risk of suicide attempt.
    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 (KP Washington Health Research Institute'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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Suicidal Ideation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    18882 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Care Management
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Skills Training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    Active Comparator
    Arm Description
    Those assigned to the Usual Care group will not be approached or contacted.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Care Management
    Intervention Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Skills Training
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Time to Fatal or Non-fatal Suicide Attempt or Self-Harm
    Description
    Electronic health records and insurance claims data will be searched for any nonfatal suicide attempts or self-harm during the 18 months after randomization. Fatal suicide attempts will be identified from state mortality data.
    Time Frame
    18 Months after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: We propose to include all patients at the participating sites 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 four 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Greg Simon, MD, MPH
    Organizational Affiliation
    KP Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    This person-level dataset will include the following variables: Time to suicide attempt or death Time to censoring for disenrollment or death from other cause Age group Sex Race/ethnicity Site of care (mental health specialty, primary care, other) PHQ9 item 9 score at baseline Year of enrollment Intervention assignment (Skills Training, Risk Assessment/Care Management, Usual Care) We do not propose to include study site (health system) in this publicly available dataset given concerns by participating health systems that such data could be used for inappropriate comparisons of suicide attempt rates across health systems.
    IPD Sharing Time Frame
    . Data will be available no later than publication date of primary study findings.
    IPD Sharing Access Criteria
    Datasets for primary analyses will be freely shared with any interested researcher or member of the public using an unsupervised public data archive model.
    Citations:
    PubMed Identifier
    27634417
    Citation
    Simon GE, Beck A, Rossom R, Richards J, Kirlin B, King D, Shulman L, Ludman EJ, Penfold R, Shortreed SM, Whiteside U. Population-based outreach versus care as usual to prevent suicide attempt: study protocol for a randomized controlled trial. Trials. 2016 Sep 15;17(1):452. doi: 10.1186/s13063-016-1566-z.
    Results Reference
    background
    PubMed Identifier
    35166800
    Citation
    Simon GE, Shortreed SM, Rossom RC, Beck A, Clarke GN, Whiteside U, Richards JE, Penfold RB, Boggs JM, Smith J. Effect of Offering Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care on Self-harm Among Adult Outpatients With Suicidal Ideation: A Randomized Clinical Trial. JAMA. 2022 Feb 15;327(7):630-638. doi: 10.1001/jama.2022.0423.
    Results Reference
    derived
    PubMed Identifier
    33884617
    Citation
    Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
    Results Reference
    derived
    PubMed Identifier
    33843599
    Citation
    Whiteside U, Richards J, Simon GE. Brief Interventions via Electronic Health Record Messaging for Population-Based Suicide Prevention: Mixed Methods Pilot Study. JMIR Form Res. 2021 Apr 12;5(4):e21127. doi: 10.2196/21127.
    Results Reference
    derived

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    UH3 Pragmatic Suicide Prevention Trial

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