Population-based outreach to prevent suicide attempts: Too big a step?

Our randomized trial of outreach programs to prevent suicide attempts tested a long step beyond what we knew from previous research.  We hoped that low-intensity adaptations of proven effective interventions – delivered primarily online – could scale up to prevent suicide attempts at the population level.  And we were wrong.  Not only did neither of the programs we tested prevent self-harm or suicide attempts, one of them may have increased risk.

Looking back, we can say that we tried too long a step beyond interventions proven to work.  We can try to unpack that long step into a few smaller pieces.  First, our trial included the broad population of people at increased risk (where most suicide attempts occur) rather than the much smaller population of people at highest risk (where previous interventions had been tested).  Second, we emphasized outreach to people who were not seeking additional help rather than limiting to volunteers who agreed in advance to accept the extra services we were offering.  Third, we tested low-intensity interventions, delivered primarily by online messaging rather than more personal and intensive interventions delivered by telephone or face-to-face.

We could have started by separately testing each of those smaller steps rather than trying to cross the creek all at once.  But any smaller trial testing one of those small steps would have taken two or three years.  Testing one smaller step after another would have taken even longer.  Given rising suicide mortality rates throughout the 2010s, we chose not to wait several years before trying a large step.  We believed the programs we tested were close enough to the solid ground of proven interventions, and we certainly hoped they would expand the reach of effective prevention.

Regardless of the time required, it may not have been helpful to divide that big step into smaller pieces.  We could have limited the trial to people at highest risk, but then we would not have studied low-intensity online interventions.  We could have limited the trial to people who agreed in advance to accept extra services, but then we would not have studied outreach interventions.

After we published our findings, we did hear questions and suggestions about each piece of the big step we tried:  Why not focus on those at highest risk?  Why not test more intense or robust interventions?  Why include people who were not interested in the treatments you were offering?  But if we’d done all of those things, we would have just replicated research that was already done – and ended up right back where we started.  Back in 2015, we already knew that traditional clinical interventions, like Dialectical Behavior Therapy, could decrease risk in treatment-seeking people with recent self-harm or hospitalization.  Replicating that evidence would not inform population-based prevention programs for the broader population of people at increased risk.     

We are certainly not giving up on the idea of population-based programs to prevent suicidal behavior.  So we’re thinking about ways to try smaller steps.  Rather than small steps, we may need to look for a completely new place to get across the creek.  Our suggestion box is open.

Greg Simon

MHRN III Pilot Project 2: Outreach to Reduce Depression Treatment Disparities

Funder: NIMH

Grant Number: U19MH121738

Project Period: 07/01/2021 – 06/30/2024

Brief Narrative:

Failure to initiate treatment is a major gap in care for depression – A recent Mental Health Research Network (MHRN) study involving more than 240,000 patients in 5 health systems with a new diagnosis of depression in primary care found that only about a third (36%) had completed a psychotherapy visit or filled a prescription for antidepressant medication within 90 days of a new depression diagnosis.
Large racial and ethnic disparities in depression treatment initiation exist – In that MHRN study the odds of Asians, Blacks and Hispanics initiating treatment were 30% lower than for Non-Hispanic Whites.
Previous research has focused on care after treatment initiation – Collaborative care and care management programs can reduce disparities, improving outcomes among traditionally under-served racial and ethnic groups. This work, however, has usually focused on those who have already initiated treatment.
Interventions to improve treatment initiation must accommodate diversity of patient experience and preferences –Underserved racial and ethnic groups may prefer psychotherapy over medication and may also prefer alternative treatments or alternative care providers. One size of depression treatment does not fit all.
eHealth technologies have the potential to address failures in treatment initiation – Previous research by MHRN investigators and others demonstrates that online messaging and other telehealth technologies can effectively and efficiently improve depression treatment adherence. These interventions, however, have focused on adherence after treatment initiation and have been tested primarily in non-Hispanic white patients.
Proposed trial: This pilot study will refine, adapt and test an outreach intervention to improve depression treatment initiation among patients recently receiving a new diagnosis of depression in primary care. Focusing on African American, Asian, Native Hawaiian/Pacific Islander and Hispanic patients, the study will leverage existing MHRN work to implement an automated outreach program with follow-up care facilitation by mental health clinicians. The intervention will utilize analytic and technological expertise developed by the MHRN to rapidly identify patients, send outreach messages, conduct assessments and facilitate care for patients with depression who fail to initiate treatment in a timely manner. The intervention will be developed with the input of patients in the target racial and ethnic minority populations and providers. Approximately 400 eligible patients in two MHRN health systems will be randomized to the intervention group or usual care. Outcomes (treatment initiation and rates recorded depression remission and response) will be ascertained from health system records. Analyses will examine intervention participation and compare the primary outcome (treatment initiation) and secondary outcomes (recorded depression remission and response) between groups. Results will inform a subsequent full-scale pragmatic trial to assess reduction in population-level disparities.

  • Lead Site:
    • KPHI (PI Vanessa Simiola)
  • Participating Sites:
    • HFHS (Site PI Lisa Matero)
    • KPWA (Co-I Greg Simon)
  • Awarded Budget (total costs):
    • Year 1: $112,382

Current Status

Over the reporting period Institutional Board Approval has been granted and focus group materials have been finalized as part of the formative research. Eligible participants were identified within the health care systems via distributed SAS code. Participant recruitment is currently underway within one (KPHI) of the two health care systems, with online focus groups scheduled in the beginning of May. The second health care system (HFHS) is awaiting local IRB approval and will begin recruitment immediately following. Provider surveys are scheduled for the end of the reporting period.

Summary of findings

Not yet available

Publications

None

Documents

Funding Announcement

Notice of Award

Personnel Contact List

Human Subjects: YES

IRB Review: KPSC is single IRB reviewing for KPHI, HFHS, and KPWA. File #12874.

Clinical Trial: YES

Pragmatic Trial of Stepped Care for Adolescent Suicide Prevention (Youth SPOT)

Grant Details

Funder: Patient-Centered Outcomes Research Institute (PCORI)

Contract Number: PLACER-2020C3-20902

Project Period: 12/01/2021 – 11/30/2027

Brief narrative:

Adolescent suicide is the second leading cause of death in teenagers. Preventing suicide in teens would keep them safe, allow them to get the mental health help that they need, and also protect families, friends, and communities from grief and loss. There are several programs that have been shown to work for preventing suicide, including an approach called dialectical behavior therapy (DBT). However, the studies done so far are so small that it is still unknown whether DBT works for all groups of teens—teens at medium risk versus those at very high risk, boys versus girls, younger versus older teens—or whether different approaches may work better for some groups. This is important information, because it would help teens and their families to make the best choices from several suicide prevention program options. Hospitals, clinics, doctors, and therapists also need information about what suicide prevention services work best and should be made more available. The goal of this study is to answer these questions.

The first aim, which will be completed in the first 18 months of the project, will be to plan the main study comparing two approaches to suicide prevention in collaboration with young people who have lived with suicidal behavior, their parents, doctors, and therapists. The second aim will be to compare how well these two approaches work to prevent suicide attempts in a group of 9,800 teens. The third aim is to see whether the two approaches lead to differences in the mental health care each teen receives—like being hospitalized, taking medications, seeing therapists, and so on—and to see which program works best for different groups, such as young men versus young women, or Hispanic teens and those who are not Hispanic, as well as what works best for teens who are at medium, medium-high, and high risk for suicide.

The first suicide prevention approach is called “stepped care,” and offers three levels of services to teens, depending on their level of risk. Medium-risk teens will be offered monthly phone check-ins; medium-high risk teens will also be offered a chance to work with a therapist to create and use safety plans that spell out how teens can keep themselves safe and what they will do if they feel suicidal. Teens at the highest level of risk will also be offered DBT group therapy for six months. The second suicide prevention approach is called Zero Suicide (ZS) care. This program is used by many healthcare clinics, hospitals, and therapy centers across the United States. It encourages therapists and doctors to ask about suicide frequently, and to make sure that teens who are at risk of suicide are connected to the best health care available, which might be regular therapy, medications, or a combination of the two.

To determine who to include in this study, the team will use a computer program to predict the chance that a teen will make a suicide attempt in the next six months. This program uses data collected by the healthcare system and is about 85 percent accurate. Teens who are at medium or high risk of suicide based on the computer program will be assigned by chance, like the flip of a coin, to one of two suicide prevention approaches. The team will use healthcare and government databases to see what happens for teens over 12 months so the team can compare rates of suicide attempts, self-harm, and healthcare use.

The goal is to help teens to be treated in a way that allows them the most personal freedom. The results from this study will help health insurers and clinics decide what kinds of suicide prevention care to offer and to cover. They will also help doctors and therapists decide what approaches to recommend to patients, and help individual teens and their families decide what kind of care to receive. The team will share its results with researchers, healthcare organizations, and national groups that advocate for youth suicide prevention to make sure that they will have the information they need to make choices about the best suicide prevention options for all types of teens.

  • Lead Sites:
    • KPNW (Clinical Coordinating Center, co-PI Greg Clarke)
    • KPGA (Data Coordinating Center, co-PI Courtney McCracken)
  • Participating Sites:
    • KPWA (site PI Rob Penfold)
    • HealthPartners (site PI Rebecca Rossom)
    • Georgia State University (site PI Ashli Owen-Smith)
    • UCLA (site PI Joan Asarnow)
    • California State Lutheran University (Site PI Jamie Bedics)

Awarded Budget (total cost): $21,324,820

Funding Announcement

Personnel Contact List

Human Subjects: YES

Current status

Pilot testing of outreach and intervention delivery will begin in October 2022.

Summary of findings

Publications

Automated Virtual Follow-Up to Reduce Premature Treatment Discontinuation

Project Name:
Automated Virtual Follow-Up to Reduce Premature Treatment Discontinuation
Grant Number:
 U19MH092201 (Pilot study under MHRN II)
Principal Investigator:
Robert Penfold, PhD
Principal Investigator Contact Information:          
robert.b.penfold@kp.org
Funder
NIMH
Funding Period:
07/2017 – 06/2019
Abstract:
Recent developments in health informatics have created the potential for more efficient and more targeted outreach programs to address dropout from depression treatment.  First, electronic medical records databases allow real-time evaluation of patients who are “overdue” for prescription refills and follow-up visits.  Second, increasing use of standardized depression severity measures (such as the PHQ9), allow efficient identification of those at risk for unfavorable outcomes.  Third, increasing use of patient-provider online messaging will permit much more efficient outreach communication.  We are conducting a pilot study of a semi- automated outreach program for adult outpatients who appear to have dropped out of acute-phase depression treatment (either pharmacotherapy or psychotherapy). Participants with missed antidepressant refills or missed psychotherapy sessions are emailed a short questionnaire to ask about their intentions for treatment as well as a PHQ9, GAD2, and AUDIT-C. Feedback on patients’ answers is delivered immediately in a web-based format.
Participating Sites:                                       
Kaiser Permanente Washington (Lead Site)
Kaiser Permanente Colorado
Investigators:
Robert Penfold, PhD
Arne Beck, PhD
Major Goals:
Conduct a pilot study of a completely automated outreach program for adult outpatients who appear to have dropped out of acute-phase depression treatment (either pharmacotherapy or psychotherapy).
Description of study sample:
The study population will include up to 2400 adult patients in participating health systems who initiate medication or psychotherapy treatment for depression.   
Current Status:
Health record data were used to identify KP adult members eligible for outreach with a new depression diagnosis who have started therapy and appear to have discontinued prematurely, but do not have a recorded good outcome (most recent PHQ9 on record total score is >=10). A secure outreach message, including a link to an externally hosted questionnaire in Research Electronic Data Capture (REDCap) was sent to identified subjects through kp.org (i.e., MyChart). The study questionnaire was comprised of (2) standard assessments used for depression and suicide risk screening and a number of treatment- specific questions.PHQ9- standard assessment measuring depression severityCSSR-S- standard assessment measuring severity of suicidal ideation/ behavior. Depression Treatment Discontinuation QuestionsSubjects who returned the questionnaire were provided tailored feedback, ranging from “glad to hear that you are planning to continue care” to “we’d like to see you feeling better/we want to make sure that you are receiving the care you need- please consider scheduling an appt.” The web-based consent process and survey were hosted on KPCO’s internal instance of Research Electronic Data Capture (REDCap)All patient recruitment and outreach activities are complete. Data collection is complete. During the recruitment phase we identified and enrolled 988 subjects meeting study criteria for initiating psychotherapy. After ongoing monitoring of enrolled subjects, 657 subjects were flagged as potentially discontinuing psychotherapy treatment early. Subjects flagged by the automated algorithm as potential ‘early discontinuers’ were manually reviewed for meeting ‘discontinuation of treatment’ study criteria. After manual review, 518 qualified subjects were outreached through the electronic health record with an invitation to complete the depression treatment questionnaire. 70 of the 518 qualified subjects who were sent an invitation to complete the depression treatment questionnaire- responded.63 fully completed AND 7 people who consented but did not fully complete all components of the questionnaire.
Study Registration:
N/A – study hasn’t started yet
Publications:
N/A
Resources:
N/A
Lessons Learned:
N/A
What’s next?
N/A

Care of Mental, Physical and Substance Use Syndromes (COMPASS)

Project Name:
Care of Mental, Physical and Substance Use Syndromes (COMPASS)
Principal Investigator:
Sanne Magnan, MD PhD; Evaluation Director: Leif Solberg, MD
Principal Investigator Contact Information:
sannemagnan@gmail.comLeif.I.Solberg@Healthpartners.com
Principal Investigator institution:
Institute for Clinical Systems Improvement; HealthPartners Institute
Funder
Centers for Medicare & Medicaid Services (CMS) / Center for Medicare & Medicaid Innovation (CMMI)
Funding Period:
07/2012 – 06/2015
Abstract:
Health care increasingly needs to develop ways to manage individuals with multiple coexisting chronic conditions. COMPASS is a partnership among 9 organizations and 18 care delivery systems nationally to implement the Collaborative Care model for patients in primary care suffering from depression as well as diabetes and/or cardiovascular disease that are not under control. The initiative reached approximately 4,000 patients in seven states, and improved depression in 40% and achieved control in 23% with diabetes and 58% with hypertension while improving patient satisfaction with care and physician satisfaction with the resources needed to manage such patients.
Grant Number:
CMS-ICI-12-001
Participating Sites:               
AIMS (Advancing Integrated Mental Health Solutions) Center at the University of Washington
Community Health Plan of Washington (CHPW)
HealthPartners Institute
Kaiser Permanente Colorado (KPCO)
Kaiser Permanente Southern California (KPSC)
Michigan Center for Clinical Systems Improvement (Mi-CCSI)
Mount Auburn Cambridge Independent Practice Association (MACIPA)
Pittsburgh Regional Health Initiative (PRHI)
Institute for Clinical Systems Improvement (ICSI)
Investigators:
Sanne Magnan, MD, PhD
Claire Neeley, MD
Leif Solberg, MD
Arne Beck, PhD
Karen Coleman, PhD
Jurgen Unutzer, MD
Rebecca Rossom, MD, MS
Lauren Crain, PhD
Michael Maciosek, PhD
Robin Whitebird, PhD, MSW, LISW
Major Goals:
The major goals are to increase the proportion of these complex uncontrolled patients who are now under control by 20% for patients with diabetes or hypertension, and to improve depression in 40%, while reducing healthcare costs
Description of study sample:
This was a demonstration project aimed at adults with active depression plus either diabetes or cardiovascular disease that were not under control. We initially targeted patients with Medicare or Medicaid, but later added other patient groups because of the unexpected difficulty of identifying and recruiting such patients.
Current Status:
The project was completed in 6/15, but most participating medical groups have continued it with a variety of modifications to fit their settings and needs
Study Registration:
N/A
Publications:
Coleman KJ, Hemmila T, Valenti MD, Smith 4, Quarrell R, Ruona LK, Brandenfels E, Hann B, Hinnenkamp T, Parra MD, Monkman J, Vos S, Rossom RC. Understanding the experience of care managers and relationship with patient outcomes: the COMPASS initiative. Gen Hosp Psychiatry. 2016 Aug 18. pii: S0163-8343(16)30164-5. doi: 10.1016/j.genhosppsych.2016.03.003. [Epub ahead of print]Coleman KJ, Magnan S, Neely C, Solberg L, Beck A, Trevis J, Heim C, Williams M, Katzelnick D, Unützer J, Pollock B, Hafer E, Ferguson R, Williams S. The COMPASS initiative: description of a nationwide collaborative approach to the care of patients with depression and diabetes and/or cardiovascular disease. Gen Hosp Psychiatry. 2016 Aug 18. pii: S0163-8343(16)30166-9. doi: 10.1016/j.genhosppsych.2016.05.007. [Epub ahead of print]Rossom RC, Solberg LI, Magnan S, Crain AL, Beck A, Coleman KJ, Katzelnick D, Williams MD, Neely C, Ohnsorg K, Whitebird R, Brandenfels E, Pollock B, Ferguson R, Williams S, Unützer J. Impact of a national collaborative care initiative for patients with depression and diabetes or cardiovascular disease. Gen Hosp Psychiatry. 2016 Aug 18. pii: S0163-8343(16)30165-7. doi: 10.1016/j.genhosppsych.2016.05.006. [Epub ahead of print]Solberg LI, Ferguson R, Ohnsorg KA, Crain AL, Williams MD, Ziegenfuss JY, et al. The challenges of collecting and using patient care data from diverse care systems: lessons from COMPASS. Am J Med Qual 2017;32(5):494-499.Whitebird RR, Solberg LI, Crain AL, Rossom RC, Beck A, Neely C, Dreskin M, Coleman KJ. Clinician burnout and satisfaction with resources in caring for complex patients. Gen Hosp Psychiatry. 2017;44(1):91-95. Jul 16. pii: S0163-8343(16)30167-0. doi: 10.1016/j.genhosppsych.2016.03.004. [Epub ahead of print]Solberg LI, Ohnsorg KA, Parker ED, Ferguson R, Magnan S, Whitebird RR, Neely C, Brandenfels E, Williams MD, Dreskin M, Hinnenkamp T, Ziegenfuss JY. Preventable hospital and emergency department events: lessons from a large innovation project. The Permanente Journal 2018 (In press).
Resources:
N/A
Lessons Learned:
It is possible to have multiple diverse health care organizations collaborate on a common improvement project and to use a common data system to aggregate data for reporting and analysis, although there are many challenges to doing so. Other lessons are available in the above publications. Additional publication in development describes the relation between care manager contacts and systematic case review to depression improvement.
What’s next?
Most participating organizations are continuing to use individually adapted versions of the COMPASS model for care but there will be no follow-on group project.

Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt

Project Name:
Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt
Principal Investigator:
Greg Simon, MD, MPH
Principal Investigator Contact Information:
Gregory.E.Simon@kp.org
Principal Investigator institution:
Kaiser Permanente Washington
Funder
NIMH
Funding Period:
09/2014 – 07/2020
Abstract:
Suicide ranks 10th among all causes of mortality in the US, accounting for over 38,000 deaths in 2010.  Non-fatal suicide attempts result in 600,000 emergency room visits and nearly 200,000 hospitalizations each year.  Recent developments have opened new opportunities to develop and evaluate population-based selective prevention programs for suicidal behavior.  First, increasing use of standard depression severity measures and recording of results in electronic medical records will allow timely and efficient identification of people at risk for suicidal behavior.  Second, efficient and scalable interventions (both structured risk assessment/care management programs and low-intensity emotion regulation skills training) have shown promise for reducing risk of suicide attempt in at-risk populations.  Third, the NIMH-funded Mental Health Research Network has established an infrastructure to adequately evaluate population-based prevention. We will conduct a large, pragmatic trial to examine two specific selective prevention programs.  Both programs are based in a re-conceptualization of suicidal ideation as an enduring vulnerability rather than a short-term crisis.  The trial will be conducted in 4 large, integrated health care systems. We propose to enroll up to 19,500 adults for whom responses to item 9 of the PHQ depression scale (regarding thoughts of death or suicide) indicate elevated risk.  Participants will be randomly assigned to continued usual care or usual care supplemented by one of the two prevention programs: An outreach and care management program (via secure messaging and telephone) including structured assessment linked to specific care pathways. An online psychoeducational program focused on development of emotion regulation skills and prevention of suicidal behaviors, supported by coaching to promote engagement and adherence. Both programs are supplements to usual care.  Both programs will capitalize on existing electronic records to improve efficiency and assure quality.  The primary outcome will be suicide attempt (fatal or non-fatal) during 18 months following enrollment – ascertained automatically from computerized records. A pragmatic trial of selective prevention would fill a major gap in current suicide prevention efforts.  Methods developed in this trial should dramatically accelerate future suicide prevention research. 
Grant Number:
UH3007755
Participating Sites:
Kaiser Permanente Washington
Kaiser Permanente Northwest
Kaiser Permanente Colorado
HealthPartners
Investigators:
Greg Simon, MD
Rebecca Rossom
Arne Beck
Greg Clarke
Major Goals:
To conduct a large, pragmatic trial to examine two population-based programs to prevent suicide attempt.  Participants will be randomly assigned to continued usual care or usual care supplemented by one of the two prevention programs: an outreach and care management program (via secure messaging and telephone) including structured assessment linked to specific care pathways, or an online psycho-educational program focused on development of emotion regulation skills and prevention of suicidal behaviors, supported by coaching to promote engagement and adherence.  The primary outcome will be suicide attempt (fatal or non-fatal) during 18 months following enrollment – ascertained automatically from computerized records.  The trial will be conducted in 4 health systems: Kaiser Permanente Washington, Kaiser Permanente Colorado, Kaiser Permanente Northwest and HealthPartners.
Description of study sample:
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.”
Current Status:
A total of 18,887 participants were enrolled, intervention procedures will continue through Fall 2019. 
Study Registration:
NCT02326883
Publications:
Shortreed SM, Rutter CM, Cook AJ, Simon GE.  Improving pragmatic clinical trial design using real-world data. Clin Trials. 2019 Jun;16(3):293-282.

Simon GE, Beck A, Rossom RC, Richards JR, Kirlin B, Shulman L, King D, Ludman EJ,   Penfold R, Shortreed SM, Whiteside US. 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.Whiteside U, Lungu A, Richards J, Simon GE, Clingan S, Siler J, Snyder L, Ludman E. Designing messaging to engage patients in an online suicide prevention intervention: survey results from patients with current suicidal ideation. J Med Internet Res. 2014 Feb 7;16(2):e42.
Resources: Specifications for defining suicide attempts are available at: https://github.com/MHResearchNetwork/MHRN-Central
Lessons Learned:
Transferring registry tools between health system Epic EMRs was more complicated than anticipated.
What’s next?
The target for completing primary analyses is Summer 2020.