UH3 Project: Suicide Prevention Outreach Trial (SPOT)
Overview
Principal Investigator:
Sponsoring Institution: Kaiser Permanente Washington Health Research Institute
Collaborators:
-
HealthPartners Institute for Education and Research
-
Kaiser Permanente Colorado
- Kaiser Permanente Northwest
- Kaiser Permanente Washington
NIH Institute Providing Oversight: National Institute of Mental Health (NIMH)
Program Official: Matthew Rudorfer, MD (NIMH)
Project Scientist: Jane Pearson, PhD (NIMH)
ClinicalTrials.gov Identifier: NCT02326883
Trial Status: Completed
Trial Summary
Study question and significance: People at risk of self-harm or suicidal behavior can be accurately identified, but effective prevention will require effective scalable interventions. The objective of this study was to compare 2 low-intensity outreach programs with usual care for prevention of suicidal behavior among outpatients who report recent frequent suicidal thoughts.
Design and setting: Pragmatic, randomized clinical trial with 18,882 outpatients reporting frequent suicidal thoughts identified using routine Patient Health Questionnaire depression screening at 4 US integrated healthcare systems between March 2015 and September 2018, with follow-up continued through March 2020.
Intervention and methods: The study compared 2 low-intensity outreach programs—care management and dialectical behavior therapy skills training—to usual care. The primary outcome was time to first nonfatal or fatal self-harm event. Secondary outcomes included more severe self-harm (leading to death or hospitalization) and a broader definition of self-harm (selected injuries and poisonings not originally coded as self-harm).
Findings: The percentage of fatal or nonfatal self-harm events was 3.1% for those receiving usual care, 3.3% for patients offered care management, and 3.9% for patients offered dialectical behavior therapy skills training. The risk of self-harm varied with patients’ level of intervention participation. In both intervention groups, patients who actively declined intervention services had the lowest risk of self-harm. Patients who did not respond to the invitation to participate or who actively participated for more than 3 months had intermediate risk. Patients who initially participated in the intervention but continued for less than 3 months had the highest risk.
Conclusions and relevance: Offering care management to adult outpatients experiencing suicidal ideation did not reduce their risk of self-harm compared to usual care. Patients offered dialectical behavior therapy skills training had significantly greater risk of self-harm compared to usual care.
Data and Resource Sharing
- SPOT Computable Phenotypes
SPOT Computable Phenotypes
- SPOT Data Dictionary
SPOT Data Dictionary
- Suicide Prevention_Simon_UH3 follow-up
SPOT Ethics and Regulatory documentation - UH3 Project Updates
- GregSimon-PragmaticTrialPopulation-BasedProgramsPreventSuicideAttempt
Minutes from Ethics/Regulatory Call with Dr. Simon’s Trial – Suicide Prevention
Featured Interview
Dr. Simon discusses the SPOT NIH Collaboratory Trial.
News and Interviews
- News_Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
December 13, 2022: In Our Tenth Year, a Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
- Video_Update on the SPOT Demonstration Project
Video Interview: Update on the SPOT NIH Collaboratory Trial
- News_Three Demonstration Projects Share Progress on Planning, Implementation, and Completion
July 26, 2022: Three NIH Collaboratory Trials Share Progress on Planning, Implementation, and Completion
- News_SPOT Finds No Reduction
February 28, 2022: SPOT Finds No Reduction in Suicide Risk for At-Risk Adults Offered Care Management, Higher Risk for Those Offered Dialectical Behavior Therapy Skills Training
- News_A Year of New Insights From the NIH Collaboratory
December 14, 2021: A Year of New Insights From the NIH Collaboratory
- News_SPOT results
September 15, 2021: PCT Grand Rounds to Announce Primary Results of NIH Collaboratory’s Suicide Prevention Outreach Trial (SPOT)
- News_A Year of Results and New Insights From the NIH Collaboratory
December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory
- News_Dr. Greg Simon Uses a Pie Eating Contest Analogy to Explain the Intraclass Correlation Coefficient
October 1, 2018: Dr. Greg Simon Uses a Pie Eating Contest Analogy to Explain the Intraclass Correlation Coefficient
- News_Dr. Greg Simon Explains Individual, Cluster, and Stepped-Wedge Randomization in a New Prop Video
December 7, 2017: Dr. Greg Simon Explains Individual, Cluster, and Stepped-Wedge Randomization in a New Prop Video
- News_New Podcast_Drs. Greg Simon and Susan Ellenberg
December 18, 2017: New Podcast: Drs. Greg Simon and Susan Ellenberg Discuss Data and Safety Monitoring in Pragmatic Trials
Publications
- SPOT Study Snapshot
SPOT Study Snapshot
- Rossom et al Psychiatr Serv 2022
Connecting research and practice: implementation of suicide prevention strategies in learning health care systems
- Simon et al JAMA 2022
SPOT Main Outcome Paper
- Whiteside et al JMIR Form Res 2021
Brief interventions via electronic health record messaging for population-based suicide prevention: mixed methods pilot study
- Ahmedani and Vannoy Am J Prev Med 2014
National pathways for suicide prevention and health services research
- Ahmedani et al J Gen Intern Med 2014
Health care contacts in the year before suicide death
- Whiteside et al J Med Internet Res 2014
Designing messaging to engage patients in an online suicide prevention intervention: survey results from patients with current suicidal ideation
- Simon et al Psychiatr Serv 2021
Reconciling statistical and clinicians' predictions of suicide risk
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Simon et al Trials 2021
Zelen design clinical trials: why, when, and how
- Simon et al medRxiv 2020
Estimating the number of self-harm events not identified by encounter diagnoses in health records
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which PCTs Should Have a DMC?
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
- Shortreed and Simon Clin Trials 2020
Using predictive analytics to improve pragmatic trial design
- Living Textbook Chapter_Advice from Healthcare System Leadership
Living Textbook Chapter: Building Partnerships: Advice from Healthcare System Leadership
- Simon et al Trials 2019
Principles and procedures for data and safety monitoring in pragmatic clinical trials
- Shortreed et al Clin Trials 2019
Improving pragmatic clinical trial design using real-world data
- Living Textbook Chapter_Deciding Who to Engage
Living Textbook Chapter: Building Partnerships to Ensure a Successful Trial - Deciding Who to Engage
- Living Textbook Chapter_Data Sharing Concerns
Living Textbook: Data Sharing Concerns
- Living Textbook Chapter_Data Sharing and Embedded Research
Living Textbook Chapter: Data Sharing Solutions for Embedded Research
- SPOT 2017-Snapshot
SPOT Study Snapshot
- Living Textbook Chapter_Assessing Feasibility
Living Textbook Chapter: Assessing Feasibility: Spotlight of Four NIH Collaboratory Trials
- Living Textbook Chapter_Implementation in the Trial vs Implementation in the Real World
Living Textbook Chapter: Dissemination and Implementation: Implementation in the Trial vs Implementation in the Real World
- Living Textbook Chapter_Data Issues With Monitoring PCTs
Living Textbook Chapter: Data and Sefety Monitoring: Data Issues With Monitoring PCTs
- Stewart et al Psychiatr Serv 2017
Changes in coding of suicide attempts or self-harm with transition from ICD-9 to ICD-10
- Simon et al Trials 2016
SPOT Study Design Paper
- Simon GE et al J Clin Psychiatry 2016
Risk of suicide attempt and suicide death following completion of the Patient Health Questionnaire depression module in community practice
- Simon GE et al Psychiatry Online 2013
Does response on the PHQ-9 depression questionnaire predict subsequent suicide attempt or suicide death?
Presentations
- SC-Mtg-2023-Day1-Simon
Greg Simon Panel Presentation 2023 Steering Committee Meeting
- 2022 NIH Workshop_Panel 1
2022 NIH Workshop Panel 1 Presentation
- 2022 NIH Workshop_Shortreed
2022 NIH Workshop SPOT Presentation
- GR-Video-09-17-21
Population-based Outreach to Prevent Suicidal Behavior: A Pragmatic Randomized Trial (GR Video 2021)
- GR-Slides-09-17-21
Population-based Outreach to Prevent Suicidal Behavior: A Pragmatic Randomized Trial (GR Slides 2021)
- SC-2019-Barriers-SPOT
Barriers and Challenges-SPOT
- Workshop Design and Analysis of PCT_Panel 2_To Cluster or Not to Cluster
Workshop Design and Analysis of PCT: Panel 2 - To Cluster or Not to Cluster
- GR-Video-11-30-18
Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome? (GR Video 2018)
- GR-Slides-11-30-18
Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome? (GR Slides 2018)
- Presentation_SPOT_ARM_2018_c
Embedding PCTs in Health Care Systems: Trials and Tribulations (SPOT) (AcademyHealth 2018)
- GR-Slides-10-27-17
Bringing Machine Learning to the Point of Care to Improve Suicide Prevention (GR Slides 2017)
- GR-Video-10-27-17
Bringing Machine Learning to the Point of Care to Improve Suicide Prevention (GR Video 2017)
- GR-Slides-09-15-17
Who to Include in a Pragmatic Trial? It Depends (GR Slides 2017)
- GR-Video-09-15-17
Who to Include in a Pragmatic Trial? It Depends (GR Video 2017)
- Simon-SC-May-2017
State of the Mental Health Research Network
- Workshop_Ethical and Regulatory Issues_Panel 1_Options for Altered Consent
Ethical and Regulatory Issues of PCTs Workshop: Panel 1 - Options for Altered Consent and the Importance of Minimal Risk Determination
- Simon_SPOT barrier scorecard
SPOT Barrier Scorecard
- Simon_SPOT data sharing
SPOT: Data Governance and Data Sharing Presentation at Steering Committee Meeting
- 11.-Simon_SPOT_Barriers-Lessons-Learned_FINAL
Suicide Prevention Outreach Trial Lessons Learned
- GR_Slides05-08-15
SPOT: Scaling Up Outreach Interventions (GR Slides 2015)
- GR-Video-05-08-15
SPOT: Scaling Up Outreach Interventions (GR Video 2017)
- Suicide Prevention_Simon_04-21-15
Update on SPOT at Steering Committee Meeting
- GR Slides 02-13-15
Data and Safety Monitoring in Pragmatic Trials (GR Slides 2015)
- GR-Video-02-13-15
Data and Safety Monitoring in Pragmatic Trials (GR Video 2015)
- Summary of Data Sharing Policy_Simon_2-24-2014
Summary of Data Sharing Policy from the Working Group
- GR Slides 04-04-14
Defining Denominator Populations Within and Across Complex Health Systems (GR Slides 2014)
- GR-Video-04-04-14
Defining Denominator Populations Within and Across Complex Health Systems (GR Video 2014)
- GR-Video-11-22-13
Using Systematic Depression Outcome Assessment for Patient Care, Quality Improvement, and Research (GR Video 2013)
- GR Slides 11-22-13-Peters
Using Systematic Depression Outcome Assessment for Patient Care, Quality Improvement, and Research (GR Slides 2013)
- GR Slides 12-14-12
Outcome Definitions and Risk Thresholds for Prevention Programs (The Case of Suicide Prevention) (GR Slides 2012)