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

Telehealth: Assessing Services in Kaiser Permanente (TASK)

Grant Details

Title: Telehealth: Assessing Services in Kaiser Permanente (TASK)

Funder: Kaiser Permanente Research

Grant Number: KPR-HPHQ-2021-01

Grant Period: 07/01/2021 – 12/31/2022

Brief Narrative: There is considerable optimism that telehealth –especially telephone and video-based visits –can transform care delivery within Kaiser Permanente (KP) and across the United States. Mental Health and Wellness (MHW) is the service line with the greatest potential to realize the benefits of expanding telehealth and transfer learning across service lines and regions. This mixed-methods project will study the quality, efficiency, and value of MHW services in six KP regions using generalized estimating equations, predictive analytics, and semi-structured interviews with members, clinicians, and administrators. The work will advance KP’s national telehealth strategy and inform capital and operational investments by improving our understanding of clinical, technical, and legal barriers and facilitators to telehealth as well as by furthering our ability to measure telehealth encounters and the relationship between telehealth and face-to-face care.

  • Lead sites:
    • KPNW (Administrative lead site, Co-PI Greg Clarke)
    • KPWA (Scientific lead site, Co-PI Robert Penfold)
  • Participating sites
    • KPCO (Site PI Jennifer Boggs)
    • KPGA (co-Site PIs Teaniese Davis& Courtney McCracken)
    • KPHI (Site PI Yihe Daida)
    • KPSC (Site PI Corinna Koebnick)

Awarded budget (total cost): $998,145

Personnel Contact List

Human Subjects: NO. All participating sites’ IRBs made a determination of quality improvement.

Current Status

Analyses are ongoing. We are evaluating:

  1. Changes in depression treatment outcomes and follow-up care with the switch to virtual care
  2. Assessing the clinical content of unscheduled telephone visits and developing measures to differentiate meaningful clinical content at these visits.
  3. Interviewing clinicians and members about their experiences
  4. Developing an updated predicting model for “no-shows” in the new (mostly) virtual environment in specialty mental health care.

Summary of findings

Interim findings suggest that positive outcomes for depression treatment were not substantially reduced by the move to virtual care. Some differences in follow-up PHQ9 administration were observed by race/ethnicity.

Qualitatively, most KP members are happy (or happier) with virtual care because of its convenience. They report only minor differences in interacting with their providers. Moderate irritation with technical issues is pervasive.

Publications

None yet.

Evaluating Zero Suicide Care Improvement Programs in MHRN Health Systems

Grant Details

Title: An Evaluation of the National Zero Suicide Model Across Learning Healthcare Systems

Funder: NIMH

Grant Number: 1U01MH114087

Grant Period: 08/03/2017 – 05/31/2022

Narrative: Health systems at six participating sites have all committed to developing and implementing various components of a National Zero Suicide Model (NZSM), originally developed at the lead site for this study, Henry Ford Health System (HFHS).  Each health system will decide which components to implement at their respective site.  This study will develop metrics to measure fidelity and outcomes for the NZSM components implemented in each system using EHR and insurance claims data.  The project will then use these metrics to conduct fidelity and outcome evaluation of the various NZSM approaches in each system using an Interrupted Time Series Design.

Short-term project objectives:

We seek to accomplish three specific aims:

  1. Collaborate with health system leaders across sites to develop EHR metrics to measure specific quality improvement targets and care processes tailored to local NZSM implementation.
  2. Examine the fidelity of the specific NZSM care processes implemented in each system.
  3. Investigate suicide attempt and mortality outcomes within and across NZSM system models.

Long-term project objectives:

Learnings from this study will be immediately available on the Zero Suicide and MHRN websites, shared directly with SAMHSA and NIMH (thru the MHRN), and disseminated broadly to health systems via Zero Suicide Training Academies well before published data are available. As such, our goal is rapid dissemination and translation to practice, as opposed to the standard research-to-practice model – which the NIH and others estimate can take 17 years.

  • Lead Site:
    • Overall PI: HFHS Brian Ahmedani
  • Participating Sites/Subcontractors:
    • KPWA (site PI Greg Simon)
    • KPCO (site PI Jennifer Boggs)
    • KPNW (site PI Greg Clarke)
  • Funder Contacts
    • Science Officer: Susan Azrin
    • Program Official: Michael Freed
    • Grants Management Official: Julie Bergerud

Documents & Reports

Funding Announcement

Personnel Contact List

Publications

Manuscripts in process

ZS manuscript tracker: https://airtable.com/shr7wfbafq5c1rwTY

MHRN manuscript proposal form: https://airtable.com/shrD81CbLqaRrF8ga

Effects of Medical Products on Suicidal Ideation and Behavior

Project Name:
Effects of Medical Products on Suicidal Ideation and Behavior
Principal Investigator:
Gregory Simon, MD, MPH
Principal Investigator Contact Information: 
gregory.e.simon@kp.org
Principal Investigator Institution:
KP Washington Health Research Institute
Funder:
Food and Drug Administration (FDA)
Funding Period:
9/30/2018 to 9/30/2021
Abstract:
We propose a comprehensive program of infrastructure development and methods development to support future generation of real-world evidence addressing these critical gaps.  The project team will include health systems and embedded research organizations with deep expertise in stakeholder engagement, medical informatics, data science, clinical epidemiology, biostatistics, pragmatic clinical trial methods, implementation science, and innovations in care delivery. Specific Tasks include: Augment the existing FDA Sentinel Initiative data infrastructure to support study of severe mental illness, suicidal ideation, and suicidal behavior. Evaluate and improve generalizability of models predicting suicidal behavior for use in future observational research and pragmatic trials. This program will be embedded in 4 integrated health systems serving a combined population of approximately 10 million members.  This work will be conducted in collaboration with health system and patient/family stakeholders, to assure that methods and evidence developed will actually address real-world questions. This infrastructure and methods development will enable a robust program of research regarding the effects of medical products on suicidal ideation and behavior, including: Scalable and re-usable methods to assess suicidal ideation and behavior as an adverse effect of existing products. Scalable and re-usable methods to assess therapeutic effects of existing products for reducing suicidal ideation and behaviorScalable and re-usable methods to rapidly evaluate possible therapeutic and adverse effects of new medical products on suicidal ideation and behavior. Large pragmatic trials to evaluate therapeutic effects of promising new product(s) on suicidal behavior
Grant Number:
N/A
Participating Sites:
Kaiser Permanente Washington
Harvard Pilgrim Healthcare
Kaiser Permanente Northern California
Kaiser Permanente Southern California
Henry Ford Health System                
Investigators:
Gregory Simon MD MPH
Susan Shortreed PhD
Yates Coley PhD
Richard Platt MD MS
Jeffrey Brown PhD
Darren Toh ScD
Jessica Young PhD
Stacy Sterling PhD
Karen Coleman PhD
Jean Lawrence ScD
Brian Ahmedani PhD
Major Goals Augment the existing FDA Sentinel Initiative data infrastructure to support study of severe mental illness, suicidal ideation, and suicidal behavior. Evaluate and improve generalizability of models predicting suicidal behavior for use in future observational research and pragmatic trials.
Description of study sample:
Various analyses are using data regarding approximately 4.5 million members of participating health systems.
Current Status:
Completed data infrastructure work includes:
– A toolkit to assess re-identification risk when sharing data derived from healthcare records:
– More timely updating of mortality data in health system research data warehouses.
– Regular reporting of availability and quality of patient-reported outcome data in health system research data warehouses.
Analyses are complete regarding:
– Value of more detailed data representation and more complex modeling methods for prediction of suicidal behavior.
– Accuracy of ICD-10-CM encounter diagnoses for identifying self-harm events.
– Value of data typically only available from electronic health records for prediction of suicidal behavior.
Study Registration:
N/A
Publications:
Simon GE, Shortreed SM, Boggs JM, Clarke GN, Rossom RC, Richards JE, Beck A, Ahmedani BK, Coleman KJ, Bhakta B, Stewart CC, Sterling S, Schoenbaum M, Coley RY, Stone M, Mosholder AD, Yaseen ZS. Accuracy of ICD-10-CM encounter diagnoses from health records for identifying self-harm events. J Am Med Inform Assoc. 2022 Aug 26:ocac144. doi: 10.1093/jamia/ocac144.
Resources:
N/A
Lessons Learned:
For prediction of suicidal behavior following outpatient mental health visits, more detailed temporal representation and more complex model development methods (random forest or neural networks vs. penalized logistic regression) do not meaningfully improve prediction accuracy.
When using prediction models to account for confounding by indication in observational studies of medication effects on suicidal behavior, random forest models may be slightly – but not meaningfully – superior to penalized logistic regression.
When using health records data to predict suicidal behavior, additional data available only from electronic health records (race, ethnicity, patient-reported outcome results) do not significantly improve prediction over data typically available from insurance claims.
What’s next?
Additional analyses will examine:
– Similarities and differences in prediction of opioid vs. other overdoses
– Similarities and differences in prediction of self-harm vs. accidental overdoses
– Changes in accuracy of suicide risk prediction models with health system implementation of Zero Suicide care improvement programs.

Pathways from Chronic Prescription Opioid Use to New Onset Mood Disorder

Grant Details

Funder: NIH, NIDA

Grant Number: R01ActDA043811

Grant Period: 4/1/2019 – 3/31/2023

Narrative: Research on the association between psychopathology and prescription opioid analgesic use (OAU) has established that mental illness influences risk of chronic OAU (i.e. >90-days), high dose OAU and misuse. We explored the reverse direction of association and found longer OAU and higher opioid doses are associated with increased risk of new onset depression (NOD), independent of pain. Using Veterans Health Affairs (VA) patient data revealed >90-day OAU was associated with a 35% (in VA patients) to 105% (in private sector patients) increased risk of NOD compared to patients with 1-30 day OAU. Our additional studies revealed that OAU is associated with depression recurrence and treatment resistant depression. If these results are confirmed in the present proposal, results have potential to greatly inform interventions to reduce chronic OAU (e.g. treating depression), elucidate pathways to OAU misuse, and generate a body of evidence that informs safe opioid prescribing. To reveal pathways from OAU to NOD and related depression phenotypes (i.e. dysthymia, bipolar, anhedonia, vital exhaustion) we must measure the patients’ pre-existing risk factors and post-OAU events. We will obtain diagnoses and symptom level data and covariates that are not available in the medical record data used in our R21 and strengthen the temporal relationships between OAU and NOD. The central hypothesis driving this research is that pre-OAU risk factors such as a history of depression and post-OAU events such as onset of opioid misuse contribute to NOD.
If NOD is explained by OAU alone and not by pre-existing risk factors, then the opioid epidemic is generating new cases of depression in a large population of middle-aged adults, otherwise not at risk for NOD. Findings will disentangle consequences or correlates of chronic pain per se from those of chronic, high dose OAU. We test whether the OAU-NOD association is moderated by pre-existing depression, substance use disorder (SUD), including opioid use disorder and trauma exposure. We next propose that post-OAU opioid misuse, SUD, poor functioning, low social support and poor sleep quality promote NOD. Using 12 monthly brief assessments, we will determine if change in OAU, independent of change in pain influences, depression trajectories and determine if there is a reciprocal relationship among these variables over time. We will determine if OAU is associated with different depression phenotypes and last determine which subtypes of depression contribute to incident opioid use disorder.

Lead Site: St. Louis University (PI Jeffrey Scherrer)

Participating Sites: HFHS (Site PI Brian Ahmedani)

Current Status:

Summary of Findings:

Publications: