UH3 Pragmatic Suicide Prevention Trial (SPOT)

UH3 Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt

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.

Study Overview

• Status: Completed
• Conditions: Depression; Suicidal Ideation
• Intervention / Treatment: Behavioral: Care Management; Behavioral: Skills Training; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 18882
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).
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.
Active Comparator: Usual Care; Those assigned to the Usual Care group will not be approached or contacted.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 Months after randomization

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Institute of Mental Health (NIMH); National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH); HealthPartners Institute
• Investigators: Principal Investigator: Greg Simon, MD, MPH, KP Washington

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: December 23, 2014
• First Submitted That Met QC Criteria: December 23, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: 4UH3MH007755 (U.S. NIH Grant/Contract); UH2AT007755 (U.S. NIH Grant/Contract); UH3MH007755 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No