| Project Name: Longitudinal Analysis of SSRI Warnings and Suicide in Youth |
| Principal Investigator Stephen Soumerai, ScD |
| Principal Investigator Contact Information: ssoumerai@hms.harvard.edu |
| Principal Investigator institution: Harvard Pilgrim Health Care |
| Funder NIMH |
| Funding Period: 09/10 – 07/2013 |
| Abstract: Approximately 14-25% of youth experience major depression before adulthood; about 9% of adolescents attempt suicide and 2.9% make a suicide attempt requiring medical attention. Treatment with antidepressant medications has been shown to improve mood and decrease suicidal ideation. However, there has been concern that antidepressants paradoxically increase the risk of suicidal behaviors following initiation of SSRI treatment. The FDA issued several public health advisories and a boxed warning since October of 2003 and, beginning in 2005, all SSRI labeling has required a “black box” warning (BBW) regarding the increased risk of suicidality in children and adolescents taking antidepressants. However, conflicting evidence concerning the true effects of SSRIs on the risk of suicidal behaviors in youth has generated much controversy. Studies following the BBW reported decreased rates of pharmacologic treatment for depression. Another study reported an 18% increase in completed suicides among youth in 2004 and 2005. This research will contribute to research regarding unintended consequences of regulatory actions. The secondary aim is to assess the utility of sequential analysis for prospectively assessing signals of health policy impacts using the antidepressant warnings as a policy example. |
| Grant Number: U19MH092201 |
| Participating Sites: Harvard Pilgrim Health Care Institute (Lead Site) Harvard Medical School Northeastern University Baylor Scott & White Health jointly with Central Texas Veterans Health Care System Kaiser Permanente Washington HealthPartners Institute Henry Ford Health System Kaiser Permanente Colorado Georgia State University Kaiser Permanente Hawaii Kaiser Permanente Kaiser Permanente Northwest Kaiser Permanente Southern California University of Tennessee Health Science Center Harvard Medical School Brigham and Women’s Hospital |
| Investigators: Stephen B. Soumerai, ScD Christine Y. Lu, PhD Sengee Toh, ScD Jessica L. Sturtevant, ScM Jeanne M. Madden, PhD Laurel Anne Copeland, PhD Gregory Simon, MD, MPH Rebecca Rossom, MD, MS Brian K. Ahmedani, PhD Gregory Clarke, PhD Marsha A. Raebel, PharmD Ashli Owen-Smith, PhD Beth Waitzfelder, PhD Yihe Daida, PhD Robert Davis, MD, MPH Stacy Sterling (Enid M. Hunkeler retired), MA, FAHA Frances Lynch, PhD Karen J. Coleman, PhD Robert Penfold Martin Kulldorff, PhD |
| Major Goals: Examine the combined effects of FDA warnings and media coverage on changes in antidepressant use, suicide attempts, and suicides among children/adolescents, young adults and adults. Evaluate the utility of sequential analysis for prospectively assessing signals of health policy impacts using FDA antidepressant warnings and related media coverage as policy example. |
| Description of study sample: Records data from 11 MHRN health systems were used to examine time trends in rates of antidepressant use, suicide attempt, and suicide death before, during, and after FDA advisories regarding suicidality during antidepressant treatment. The combined sample included approximately 1.1 million adolescents aged 10-17, 1.4 million adults aged 18-29, and 5 million adults aged 30-64. |
| Current Status: (write 1-2 sentences describing the project status; include current date) Our latest publication in May 2018 evaluated the utility of sequential analysis for prospectively assessing signals of health policy impacts. As a policy example, we studied the consequences of the widely publicized Food and Drug Administration’s warnings cautioning that antidepressant use could increase suicidal risk in youth. Prospective, periodic evaluation of administrative health care data using sequential analysis can provide timely population-based signals of effects of health policies (see below). This method may be useful to use as new policies are introduced. Along with this publication Drs. Lu, Soumerai, Simon, and Kulldorff published point and counterpoint articles in Medical Care regarding the importance of surveillance (see below). Analysis for this project is complete and there will be no more publications. Using 28 years of US death certificate data collected and validated by the US CDC from 1990 to 2017, we are conducting the first longitudinal study of discontinuities in the trends of suicide rates before and after the warnings among adolescents and young adults. We hypothesized that the warnings and reductions in depression diagnosis and treatment would be associated with an increase in completed suicides among adolescents and young adults in the US. There are no extant national longitudinal data on the effects of this policy on completed suicides. |
| Study Registration: N/A |
| Publications:Lu CY, Stewart C, Ahmed AT, Ahmedani BK, Coleman K, Copeland LA, Hunkeler EM, Lakoma MD, Madden JM, Penfold RB, Rusinak D, Zhang F, Soumerai SB. How complete are E-codes in commercial plan claims databases? Pharmacoepidemiol Drug Saf. 2014 Feb;23(2):218-20. doi: 10.1002/pds.3551.Lu CY, Zhang F, Lakoma MD, Madden JM, Rusinak D, Penfold RB, Simon G, Ahmedani BK, Clarke G, Hunkeler EM, Waitzfelder B, Owen-Smith A, Raebel MA, Rossom R, Coleman KJ, Copeland LA, Soumerai SB. Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study. BMJ. 2014 Jun 18;348:g3596. doi: 10.1136/bmj.g3596.Lu, CY, Penfold RB, Toh S, Sturtevant J, Madden JM, Simon G, Ahmedani BK, Clarke G, Coleman KJ, Copeland L, Daida Y, Davis RL, Hunkeler EM, Owen-Smith A, Raebel MA, Rossom MA, Soumerai SB, Kulldorff M. Near real-time surveillance for consequences of health policies using sequential analysis. Med Care. 2018 May;56(5):365-372.Lu, CY, Simon, G, Soumerai, SB, Kulldorff, M. Early warning systems are imperfect, but essential. Med Care. 2018 May;56(5):382-383.Lu, CY, Simon, G, Soumerai, SB. Staying honest when policy changes backfire. Med Care. 2018 May;56(5):384-390. |
| Resources:N/A |
| Lessons Learned: Completeness of e-codes varies significantly over time, across treatment settings and across study sites. Improvements in e-coding in commercial health plan datasets are critical for injury research. In the meantime, poisoning by psychotropic drugs appears to be a useful proxy for identifying suicide attempts leading to emergency room visits and hospitalizations. There were substantial reductions in antidepressant use among all age groups and simultaneous, small increases in psychotropic drug poisonings, a validated measure of suicide attempts, among adolescents and young adults following the FDA warnings. These results were consistent across 11 geographically diverse U.S. study sites. Media exaggeration about FDA reports of drug risks may reduce appropriate drug use and increase adverse outcomes. We did not detect changes in completed suicides after the warnings, which is an extremely rare outcome. |
| What’s Next? The Virtual Data Warehouse (VDW) provides a rich resource for multi-site research. The longitudinal nature of the VDW enables longitudinal analyses that are necessarily part of the interrupted time series method, a strong quasi-experimental study design for studying impacts of health policies. MHRN hosts a health policy special interest group for discussing these research ideas. |
Tag: Suicide prevention
Firearms means restriction for suicide prevention in pediatric primary care
| Project Name: Intervention mapping to develop multi-level implementation strategies in partnership with stakeholders: Firearms means restriction for suicide prevention in pediatric primary care |
| Principal Investigator: Rinad Beidas, PhD |
| Principal Investigator Contact Information: rbeidas@upenn.edu |
| Principal Investigator institution: University of Pennsylvania |
| Funder: NIMH |
| Funding Period: 05/2016 – 07/2018 |
| Abstract: Suicide is a leading cause of death in children and adolescents and a critical public health concern. One promising suicide prevention strategy that is under-utilized includes reducing access to lethal means, or means restriction. Firearms are an important target for means restriction given that 1 in 3 homes possess a firearm and firearms are the most lethal manner by which suicide is attempted. Primary care is an ideal setting in which to provide firearms means restriction given that almost half of youth who die by suicide do not access specialty mental health services in the 12 months preceding their attempt. The Safety Check intervention is an evidence-based practice for implementing firearms means restriction in pediatric primary care (including pediatrics, family medicine, and adolescent medicine). Despite the existence of this intervention and recommendations from the American Academy of Pediatrics, providers rarely discuss means restriction or firearms during visits, suggesting the need for a better understanding of the barriers and facilitators to implementing means restriction in pediatric primary care. Implementation science frameworks, including the Consolidated Framework for Implementation Research (CFIR), suggest the importance of attending to multiple levels of context during implementation, including provider (e.g., self-efficacy), organizational (e.g., expectations about provider behavior), system (e.g., prompts in the electronic health records), and intervention (e.g., acceptability) factors. The NIMH-funded Mental Health Research Network (MHRN), a consortium of 13 healthcare systems across the United States, affords a unique opportunity to better understand how to implement means restriction in pediatric primary care from a system-level perspective. Our objective in this application is to collaboratively develop implementation strategies in partnership with MHRN stakeholders to increase the use of means restriction in pediatric primary care. In Aim 1, we will survey leadership and primary care providers of 96 primary care practices within 2 MHRN systems (Henry Ford Health System and Baylor Scott & White Health) to understand acceptability and use of the three components of the Safety Check intervention (i.e., screening, brief counseling around gun safety, and provision of gunlocks). In Aim 2, in collaboration with MHRN stakeholders in these 2 systems, we will use intervention mapping and the CFIR to systematically develop and evaluate a multi-level menu of implementation strategies for firearm means restriction in pediatric primary care. The proposed work is consistent with the NIMH strategic plan, specifically Objective 4, to strengthen the public health impact of NIMH-supported research, and will lead to a hybrid effectiveness-implementation R01 proposal. The long-term goal of this line of research is to reduce death by suicide by increasing the use of evidence-based strategies in pediatric primary care while also promoting multi-level implementation strategies informed by a systematic and rigorous development approach. |
| Grant Number: 1R21MH109878-01 |
| Participating Sites: Henry Ford Health System Baylor Scott & White Health |
| Investigators: Rinad Beidas, PhD Brian Ahmedani, PhD John Zeber, PhD Steven Marcus, PhD Courtney Benjamin Wolk, PhD Shari Mintz, PhD Joel Fein, MD, MPH Gregory Brown, PhD |
| Major Goals: To partner with MHRN stakeholders and engage in quantitative and qualitative inquiry around how to implement an evidence-based program for firearm safety as a suicide prevention strategy for youth in primary care. |
| Description of study sample: The sample for Aim 1 includes leaders from HFHS and BSW; and primary care providers from HFHS and BSW. 204 PCPs and 57 CLs were eligible for the survey; 103 (50.4%) PCPs and 40 (70.2%) CLs participated. The sample from Aim 2 includes 4-12 individuals from each of the following stakeholder groups (n=70): parents of youth that receive pediatric primary care at a HFHS clinic; physician providers; non-physician providers; leaders of primary care practices; leaders of behavioral health; leaders of quality improvement; system leaders; third-party payers, members of national credentialing bodies, and gun-owning constituents. |
| Current Status:9/27/18 Aim 1: We collected quantitative primary data about the acceptability and use of the three EBPs in the survey, as reported previously. We also collected secondary data via publicly available data sources, including data from the MHRN virtual data warehouse and the National Center for Health Statistics’ National Vital Statistics System. Additionally, we extracted youth (aged 12-24) suicide deaths over the past five years by firearm at the county level for each primary care practice location from the National Vital Statistics System. We have submitted the manuscript summarizing Aim 1 findings, and it is currently under peer review. Aim 2: We trained research staff and successfully conducted qualitative interviews for all stakeholder groups (n=70). We added a stakeholder group (gun-owning constituents) given our experiences with the qualitative interviews. We have completed all interviews and enrolled 7 parents, 7 primary care physicians, 7 non-physician providers, 7 clinical leaders, 6 system leaders, 6 leaders of behavioral health, 7 leaders of quality improvement, 4 third-party payers, 7 members of national credentialing bodies, and 12 gun owners. We evaluated all interviews to identify common themes related to barriers, facilitators, and implementation strategies. Upon gathering this information, we used the spirit of intervention mapping, in concert with the Consolidated Framework for Implementation Research (CFIR), to inform the development of a menu of implementation strategies. All interviews were transcribed and loaded into NVivo software for data management. Our team developed two different comprehensive coding schemes, one for the original set of stakeholders and one for gun-owner constituents, given that different themes emerged. We completed coding of all transcripts, and the coders maintained excellent reliability. From the interviews, we gleaned a number of themes around barriers, facilitators, and implementation strategies regarding the potential implementation of our intervention of interest. Overall, the interviews underscored the importance of considering how to best support providers to improve their self-efficacy and implement new practices (e.g. providing ongoing consultation, leveraging existing mental health screening/ suicide prevention initiatives), since providers are already overextended and have little time to implement additional practices. The manuscript is currently under review. Currently, we are preparing a manuscript specifically detailing the views of the gun-owner constituents,.Through the use of intervention mapping, we developed a list of implementation strategies, based off feedback from stakeholders who completed the qualitative interviews. After compiling the list, we returned to those original stakeholders and asked them to complete a brief online survey assessing feasibility, acceptability, and importance of each strategy. In total, we received 35 responses (roughly 69%). By administering the online survey, we were able to generate a refined list of the most feasible and acceptable implementation strategies under each level. We are currently drafting a manuscript that describes how our team selected the implementation strategies, using the process of intervention mapping. |
| Study Registration: N/A |
| Publications: Wolk CB, Jager-Hyman S, Marcus SC, Ahmedani BK, Zeber JE, Fein JA, Brown GK, Lieberman A, Beidas RS. Developing implementation strategies for firearm safety promotion in paediatric primary care for suicide prevention in two large US health systems: a study protocol for a mixed-methods implementation study. BMJ Open. 2017 Jun 24;7(6):e014407. doi: 10.1136/bmjopen-2016-014407.Jager-Hyman, S., Wolk, C. B., Ahmedani, B. K., Zeber, J. E., Fein, J. A., Brown, G. K., Byeon, Y. V., Listerud, H., Gregor, C. A., Lieberman, A., & Beidas, R. S. (in press). Perspectives from firearm stakeholders on firearm safety promotion in pediatric primary care as a universal suicide prevention strategy: A qualitative study. Journal of Behavioral Medicine. Beidas, R. S., Jager-Hyman, S., Becker-Haimes, E., Wolk, C., Ahmedani, B., Zeber, J., Fein, J., Brown, G., Gregor, C., Lieberman, A., & Marcus, S.: Acceptability and use of evidence-based practices for firearm storage in pediatric primary care. Academic Pediatrics. November 2018.Wolk, C. B., Van Pelt, A., Jager-Hyman, S., Ahmedani, B., Zeber, J., Fein, J., Brown, G., Gregor, C., Lieberman, A., & Beidas, R. S.: Stakeholder perspectives on implementing a firearm safety intervention in pediatric primary care as a universal suicide prevention strategy: A qualitative study. JAMA Network Open. November 2018.Beidas, R.: How your child’s primary-care doctor can prevent gun injury and death. Philly.com. December 2018. (OP ED) |
| Resources: N/A |
| Lessons Learned: N/A |
| What’s next? We will submit an application to NIMH in 2019 to conduct a hybrid trial evaluating both the effectiveness of the adapted Safety Check in pediatric primary care and the implementation strategies we use to implement it. |
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. |
Precursors of first-episode psychosis in a population-based sample
| Project Name: Precursors of first-episode psychosis in a population-based sample |
| Principal Investigator: Gregory Simon, MD MPH |
| Principal Investigator Contact Information: simon.g@ghc.org |
| Principal Investigator institution: Kaiser Permanente Washington |
| Funding Period: 07/2013 – 06/2018 |
| Abstract: Schizophrenia is estimated to be the 8th-ranked cause of life years lost to disability and premature death among people aged 15 to 44. Reducing this disease burden is a public health priority. Among people experiencing first onset of psychotic symptoms, delay in receipt of effective treatment contributes significantly to poor long-term outcomes. Furthermore, warning signs or prodromal symptoms may be identifiable prior to onset of actual psychotic symptoms. Accumulating evidence suggests that preventive interventions (prior to onset of actual psychotic symptoms) or early clinical interventions (to reduce the interval between onset of symptoms and receipt of effective care) can both improve long-term prognosis. Existing models for early detection and early intervention – either for research or care delivery – have limited reach and scalability. Our preliminary studies suggest that a generalizable algorithm retrospectively applied to electronic medical records data can accurately identify first episodes of psychosis with a positive predictive value of 80 to 90% and a sensitivity of over 80% – when compared to structured chart review. If electronic records in large health systems could be used to efficiently identify large and representative samples of people experiencing first-episode psychosis, this method could dramatically accelerate research and transform care delivery. We propose a population-based research program to address immediate questions regarding early intervention programs and to develop methods to support the next generation of early intervention research. This research will draw from five large health systems serving a diverse and representative population of over 7.5 million people. Specific aims of this program include: Use electronic records data from large integrated health care systems to validate and refine a generalizable algorithm for identifying first presentations of psychosis. Examine patterns of health care contact prior to first diagnosis of psychosis to identify the optimal care settings and target populations for early detection programs and preventive interventions. Examine patterns of treatment following first diagnosis of psychosis in order to identify the gaps in care leading to prolonged duration of untreated psychosis. Examine sources of health insurance coverage at first diagnosis of psychotic disorder and subsequent lapses in coverage in order to inform the design of future intervention programs. Explore the use of text mining methods to identify potential indicators of prodromal symptoms in notes of outpatient visits prior to first diagnosis of psychosis in order to develop innovative strategies for accurate real-time identification of prodromal symptoms. Understand patient, family, and clinician perspectives regarding population-based research outreach following a new diagnosis of psychosis to inform future research and care delivery. Examine rate and causes of mortality after first diagnosis of psychotic disorder |
| Grant Number: 5R01MH099666 |
| Funder: NIMH |
| Participating Sites: Group Health Cooperative Kaiser Permanente Colorado Kaiser Permanente Northern California Kaiser Permanente Northwest Kaiser Permanente Southern California |
| Investigators: Gregory Simon, MD MPH David Carrell, PhD Frances Lynch, PhD Bobbi Jo Yarborough, PhD Carla Green, PhD Arne Beck, PhD Enid Hunkeler, MA Stacy Sterling, PhD Karen Coleman, PhD |
| Major Goals: Goals include Aim 1: Describe initial presentation with psychotic symptoms in a population-based sample. Aim 2: Examine patterns of care prior to diagnosis. Aim 3: Examine treatment adherence/continuity after diagnosis. Aim 4: Examine impact of health insurance coverage. Aim 5: Mine clinical text to identify possible prodromal “signals”. Aim 6: Explore acceptability of outreach interventions. Aim 7: Examine mortality after first diagnosis of psychotic disorder |
| Description of study sample: Cases: First diagnosis of schizophrenia spectrum psychosis, mood disorder with psychosis or other psychotic disorder between 1/1/2007 and 12/31/2012. Continuously enrolled in the health plan for >=12 months prior to the initial diagnosis. Age 15 and above. Controls: No prior record of psychosis or mood disorder. Continuously enrolled in the health plan for >=24 months. Age 15 and above. Meet one of these criteria for one of three control groups. First diagnosis of depression (matched to cases by age, sex, and year)First diagnosis of inflammatory bowel disease (matched to cases by age, sex, and year)Any outpatient visit (matched to cases by age, sex, and year). |
| Current Status: Analyses for all aims are complete |
| Study Registration: N/A |
| Publications: Simon GE, Coleman KJ, Yarborough BJ, Operskalski B, Stewart C, Hunkeler EM, Lynch F, Carrell D, Beck A. First presentation with psychotic symptoms in a population-based sample. Psychiatr Serv. 2017; 68: 457-461.Simon GE, Stewart C, Yarborough BJ, Lynch F, Coleman KJ, Beck A, Operskalski BH, Penfold RS, Hunkeler EM. Mortality after first diagnosis of psychotic disorder in adolescents and young adults. JAMA Psychiatry 2018; 75: 254-260.Simon GE, Stewart C, Hunkeler EM, Yarborough BJ, Lynch F, Coleman KJ, Beck A, Operskalski BH, Penfold RS, Carrell DS. Care pathways prior to first diagnosis of psychotic disorder in adolescents and young adults. Am J Psychiatry 2018 (Jan 24 epub ahead of print). |
| Resources: None available yet |
| Lessons Learned: DetectionIncidence rate suggests reasonable capture of all new casesHalf have some prior mental health contact. Patterns of utilization prior to first diagnosis differ by race/ethnicityInitiation>90% without patient specialty MH follow-up within 1 month>60% with filled prescription for antipsychotic medication within 1 month. Engagement/ContinuationOnly 50% still engaged in outpatient specialty MH care by 1 yea. rOf those who disengage: outcome is poor in 1/3 and unknown in 1/3 MortalityMortality is markedly increased soon after first diagnosis of psychotic disorderExcess mortality is largely due to injuries and poisonings, especially self-inflicted injuries and poisonings |
| What’s next? Submit manuscripts for Aims 3 to 7 |
Suicide Supplement: Development of a Population-Based Risk Calculator for Suicidal Behavior
| Project Name: Suicide Supplement: Development of a Population-Based Risk Calculator for Suicidal Behavior |
| 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: 07/2015 – 06/2017 |
| Abstract: We propose to use population-based data from large health systems to develop evidence-based suicide attempt risk calculators for mental health and primary care clinicians. Seven Mental Health Research Network (MHRN) sites will contribute data to this work. Domains of predictors or risk indicators will include: Sociodemographic characteristics: age, sex, race/ethnicity, household socioeconomic statusGeneral clinical history: psychiatric diagnoses, co-occurring substance use disorder, co-occurring medical illness, outpatient treatment history, inpatient treatment historySuicidal behavior history: prior suicide attempt, other prior injury or poisoningSuicidal ideation history: number, timing, and results of previous responses to PHQ item 9Current presentation: depression and anxiety symptom severity, frequency/intensity of suicidal ideation, current substance useNonfatal and fatal suicide attempts will be identified using health system records and state mortality data. Analyses will estimate cumulative hazard of suicide attempt over 30, 90, and 180 days following an index encounter, contingent on specific characteristics in each of the five predictor domains listed above. We will build predictive models using all observations on the same individual over time as well as randomly sampling one observation per individual – to assess the bias in the risk prediction model in the combined population. We will use statistical learning methods to build and evaluate prediction models to identify who is at increased risk of suicide and when that risk is reduced or elevated. Results of these analyses will inform creation of EHR-based risk calculator tools to support outpatient providers’ decisions regarding suicide risk assessment and follow-up care. Distinct models and decision support tools will be used to inform pre-visit planning (using all risk factor information present prior to the index visit) and within-visit planning (using additional information recorded during the index visit). |
| Grant Number: U19MH092201 (Supplement under MHRN II) |
| Participating Sites: Kaiser Permanente, Washington Henry Ford Health Systems, Michigan HealthPartners Institute for Education and Research, Minnesota Kaiser Permanente, Colorado Kaiser Permanente, Hawaii Kaiser Permanente, Northwest Kaiser Permanente, Southern California |
| Investigators: Gregory Simon, MD, MPH Brian Ahmedani, PhD Rebecca Rossom, MD, MSCR Arne Beck, PhD Beth Waitzfelder, PhD Frances Lynch, PhD Karen Coleman, PhD |
| Major Goals: This study will inform creation of EHR-based risk calculator tools to support outpatient providers’ decisions regarding suicide risk assessment and follow-up care. Our consultations with stakeholders (both front-line clinicians and health system leaders) identify two key information needs: Pre-visit planning – Prior to each visit (all mental health specialty visits or primary care visits for patients with mental health conditions), treating providers would receive a risk prediction based on clinical information available prior to the appointment. This predicted risk score would be calculated using Epic’s Reporting Workbench functions and displayed in each provider’s Epic Schedule Review function, following a process now used for other clinical risk prediction tools in participating health systemsWithin-visit assessment – During each visit, entry of PHQ9, GAD2/7 or AUDIT-C questionnaire data would trigger an updated risk prediction, incorporating most recent response to PHQ item 9 as well as other symptom severity scales. This predicted risk score would be calculated and displayed using Epic’s SmartLink function, following a process now used for cardiovascular risk predictions. In addition to serving different practical needs (pre-visit preparation and within-visit treatment planning), these alternative models will address a more general scientific or public health question: the relative importance of long-term characteristics and time-varying or immediate characteristics in predicting risk of suicidal behavior. |
| Description of study sample: The sample will include all patients aged 13 or older with at least one outpatient visit between 1/1/2009 and 6/30/2015 that is either with a specialty mental health provider OR with a recorded diagnosis of mood, anxiety, personality, or psychotic disorder. Sample includes 19.6 million visits for approximately 2.9 million people. |
| Current Status: Data have been collected from participating sites and combined, creating one analytic dataset. Primary analyses are complete (as of 3/1/2018) with some secondary analyses ongoing. |
| Study Registration: N/A |
| Publications: Simon GE, Johnson E, Lawrence JM, Rossom RC, Ahmedani B, Lynch FL, Beck A, Waitzfelder B, Ziebell R, Penfold RB, Shortreed SM. Predicting suicide attempts and suicide deaths following outpatient visits using electronic health records. Am J Psychiatry 2018: May 24 (epub ahead of print)Simon GE, Shortreed SM, Coley RY, Penfold RB, Rossom RC, Waitzfelder BE, Sanchez K, Lynch FL. Assessing and Minimizing Re-identification Risk in Research Data Derived from Health Care Records. EGEMS (Wash DC). 2019 Mar 29;7(1):6. doi: 10.5334/egems.270.Simon GE, Yarborough BJ, Rossom RC, Lawrence JM, Lynch FL, Waitzfelder BE, Ahmedani BK, Shortreed SM. Self-Reported Suicidal Ideation as a Predictor of Suicidal Behavior Among Outpatients With Diagnoses of Psychotic Disorders. Psychiatr Serv. 2019 Mar 1;70(3):176-183. doi: 10.1176/appi.ps.201800381. Epub 2018 Dec 10. |
| Resources: Code for identifying the study sample and computing predictors is available via the MHRN GitHub site: https://github.com/MHResearchNetwork |
| Lessons Learned: Prediction models using electronic health records data can accurately identify outpatients at increased risk for suicide attempt and suicide death. Separate prediction models for adolescents are not necessary. Self-reported suicidal ideation accurately predicts suicide attempt in people with psychotic disorders. |
| What’s next? Secondary analyses may lead to additional manuscripts regarding: Risk prediction in adolescentsRisk prediction in people with substance use disordersDisagreement between risk models and self-reported suicidal ideationVariation in accuracy of risk prediction across racial and ethnic groups |
Treatment Utilization Before Suicide
| Project Name: Treatment Utilization Before Suicide |
| Principal Investigator: Brian Ahmedani, PhD |
| Principal Investigator Contact Information: BAHMEDA1@HFHS.ORG |
| Principal Investigator institution: Henry Ford Health System Research Centers |
| Funder: NIMH |
| Funding Period: 03/2015 – 02/2020 |
| Adult suicide rates in the United States rose by almost 30 percent between 1999 and 2010. These rates have not markedly improved in decades. To date, previous suicide attempts and psychiatric diagnoses are largely the only known clinical risk factors for suicide death. Recent research shows that most individuals who die by suicide make a health care visit in the weeks and months prior to their death. Most of these visits occur in primary care or outpatient medical specialty settings. However, over half of these visits do not include a psychiatric diagnosis. Thus, there is limited evidence available from health care users in the US general population to inform targeted suicide screening and risk identification efforts in general medical settings. New research is needed to investigate the general medical clinical factors associated with suicide risk among individuals without a known risk factor. This research project uses data on more than 4000 individuals who died by suicide and made health care visits to one of eight health care systems across the United States in the year prior to their death. These health systems are members of the Mental Health Research Network and have affiliated health plans. They are able to capture nearly all health care for their patients via the Virtual Data Warehouse (VDW). The VDW consists of electronic medical record and insurance claims data organized using standardized data structures and definitions across sites. These data are matched with official regional mortality data. This project includes the following Specific Aims: 1) Identify the types and timing of clinical factors prior to suicide, 2a) Compare clinical factors before suicide to a matched sample of health care users, 2b) Detect associations between additional clinical factors and suicide, and 3) Develop a prediction model of clinical factors prior to suicide. We employ a case-control study approach to test specific hypotheses, while also using novel environment-wide association study methods and latent class analysis to detect new risk factors. We develop a prediction model of clinical factors and suicide. Clinical factors to be studied include medical diagnoses, medications, health care procedures, and types of health care visits. These results will inform decisions about how to focus suicide prevention in medical settings and provide information in response to the 2012 National Action Alliance for Suicide Prevention and US Surgeon General report. |
| Grant Number: R01MH103539 |
| Participating Sites: Henry Ford Health System Harvard Pilgrim Healthcare HealthPartners Kaiser Permanente Hawaii Kaiser Permanente Northwest Kaiser Permanente Colorado Kaiser Permanente Georgia Kaiser Permanente Washington |
| Investigators: Brian K. Ahmedani, PhD Gregory E. Simon, MD, MPH Rebecca Rossom, MD, MSCR Arne Beck, PhD Frances Lynch, PhD Beth Waitzfelder, PhD Christine Lu, PhD Ashli Owen-Smith, PhD Deepak Prabhakar, MD, MPH L. Keoki Williams, MD, MPH Edward Peterson, PhD Cathrine Frank, MD |
| Major Goals: The main goal of this project is to investigate general medical and other healthcare factors and risk of suicide to develop a comprehensive healthcare algorithm to predict suicide, with particular focus on general medical settings. |
| Description of study sample: This large case-control study includes >3,000 individuals who died by suicide between 2000-2015 and >300,000 matched general population members of 8 large health systems across the United States. |
| Current Status: June 26, 2019: Aims 1-2 have been completed. The work in Aim 3 is currently underway, including developing a series of predictive models for the full sample and a series of subgroups.. We will complete data analysis and draft the manuscript in Winter 2019-2020. |
| Study Registration: N/A |
| Publications:Ahmedani BK, Simon GE, Stewart C, Beck A, Waitzfelder BE, Rossom R, Lynch F, Owen-Smith A, Hunkeler EM, Whiteside U, Operskalski BH, Coffey MJ, Solberg LI. Health care contacts in the year before suicide death. J Gen Intern Med. 2014 Jun;29(6):870-7. doi: 10.1007/s11606-014-2767-3. PMID: 24567199Ahmedani BK, Stewart C, Simon GE, Lynch F, Lu CY, Waitzfelder BE, Solberg LI, Owen-Smith AA, Beck A, Copeland LA, Hunkeler EM, Rossom RC, Williams K. Racial/Ethnic differences in health care visits made before suicide attempt across the United States. Med Care. 2015 May;53(5):430-5. doi: 10.1097/MLR.0000000000000335. PMID: 25872151.Ahmedani BK, Peterson EL, Hu Y, Rossom RC, Lynch F, Lu CY, Waitzfelder BE, Owen-Smith AA, Hubley S, Prabhakar D, Williams LK, Zeld N, Mutter E, Beck A, Tolsma D, Simon GE. Major Physical Health Conditions and Risk of Suicide. Am J Prev Med. 2017 Sep;53(3):308-315. doi: 10.1016/j.amepre.2017.04.001. PMID: 28619532.Boggs JM, Simon GE, Ahmedani BK, Peterson E, Hubley S, Beck A. The Association of Firearm Suicide With Mental Illness, Substance Use Conditions, and Previous Suicide Attempts. Ann Intern Med. 2017 Aug 15;167(4):287-288. doi: 10.7326/L17-0111. PMID: 28672343.Prabhakar D, Peterson EL, Hu Y, Rossom RC, Lynch FL, Lu CY, Waitzfelder BE, Owen-Smith AA, Williams LK, Beck A, Simon GE, Ahmedani BK. Dermatologic Conditions and Risk of Suicide: A Case-Control Study. Psychosomatics. 2018; 59(1): 58-61. doi: 10.1016/j.psym.2017.08.001. PMID: 28890116.Boggs JM, Beck A, Hubley S, Peterson EL, Hu Y, Williams LK, Prabhakar D, Rossom RC, Lynch FL, Lu CY, Waitzfelder BE, Owen-Smith AA, Simon GE, Ahmedani BK.General Medical, Mental Health, and Demographic Risk Factors Associated With Suicide by Firearm Compared With Other Means. Psychiatric Services. 2018; 69(6):677-684. doi: 10.1176/appi.ps.201700237. PMID: 29446332.Owen-Smith AA, Ahmedani BK, Peterson E, Simon GE, Rossom RC, Lynch FL, Lu CY, Waitzfelder BE, Beck A, DeBar LL, Sanon V, Maaz Y, Khan S, Miller-Matero LR, Prabhakar D, Frank C, Drake CL, Braciszewski JM. The Mediating Effect of Sleep Disturbance on the Relationship Between Nonmalignant Chronic Pain and Suicide Death. Pain Pract. 2019 Apr;19(4):382-389. doi: 10.1111/papr.12750. Epub 2019 Jan 18. PMID: 30462885Yeh HH, Westphal J, Hu Y, Peterson EL, Williams LK, Prabhakar D, Frank C, Autio K, Elsiss F, Simon GE, Beck A, Lynch FL, Rossom RC, Lu CY, Owen-Smith AA, Waitzfelder BE, Ahmedani BK. Diagnosed Mental Health Conditions and Risk of Suicide Mortality. Psychiatr Serv. 2019 Jun 12:appips201800346. doi: 10.1176/appi.ps.201800346. [Epub ahead of print]. PMID: 31185853 |
| Resources: None |
| Lessons Learned: Most individuals make healthcare visits before suicide. Most visits occur in primary care or general medical specialty settings. Approximately half of individuals do not have a mental health condition diagnosed during their health care visits before suicide. Among 19 physical health conditions under study, 17 were associated with increased risk for suicide after adjustment for age and sex, and 9 associations persisted after additional adjustment for mental health and substance use conditions. |
| What’s next? The final predictive modeling analyses are underway for the final study aim. A series of papers are currently under review or in development based on data from Aims 1-2. |