title: Population-based outreach versus care as usual to prevent suicide attempt: study protocol for a randomized controlled trial.
abstract: Suicide remains the 10th-ranked most frequent cause of death in the United States, accounting for over 40,000 deaths per year. Nonfatal suicide attempts lead to over 200,000 hospitalizations and 600,000 emergency department visits annually. Recent evidence indicates that responses to the commonly used Patient Health Questionnaire (PHQ9) can identify outpatients who are at risk of suicide attempt and suicide death and that specific psychotherapy or Care Management programs can prevent suicide attempts in high-risk patients. Motivated by these developments, the NIMH-funded Mental Health Research Network has undertaken a multisite trial of two outreach programs to prevent suicide attempts among outpatients identified by routinely administered PHQ9 questionnaires.
  
  
  
  Outpatients who are at risk of suicide attempt are automatically identified using data from electronic health records (EHRs). Following a modified Zelen design, all those identified are assigned to continued usual care (i.e., no contact) or to be offered one of two population-based outreach programs. A Care Management intervention includes systematic outreach to assess suicide risk, EHR-based tools to implement risk-based care pathways, and care management to facilitate recommended follow-up. A Skills Training intervention includes interactive online training in Dialectical Behavior Therapy skills, supported by reminder and reinforcement messages from a skills coach. Each intervention supplements, rather than replaces, usual care; participants may receive any other services normally available. Interventions are delivered primarily by secure messaging through EHR patient portals. Suicide attempts and deaths following randomization are identified using state vital statistics data and health system EHR and insurance claim data. Primary evaluation will compare risk of suicide attempt or death over 18 months according to the initial assignment, regardless of intervention participation. Recruitment is underway in three health systems (Group Health Cooperative, HealthPartners, and Kaiser Permanente Colorado). Over 2500 participants have been randomized as of 1 March 2016, with enrollment averaging approximately 100 per week.
  
  
  
  Assessing the effectiveness of population-based suicide prevention requires adherence to the principles of pragmatic trials: population-based enrollment, accepting variable treatment participation, assessing outcomes using health record data, and analyses based on intent-to-treat.
  
  
  
  ClinicalTrials.gov registration # NCT02326883 , registered on 23 December 2014.
authors.affiliation: Group Health Research Institute, 1730 Minor Ave. #1600, Seattle, WA, 98101, USA. simon.g@ghr.org.
authors.forename: Gregory E
authors.initials: GE
authors.lastname: Simon
authors.affiliation: Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA.
authors.forename: Arne
authors.initials: A
authors.lastname: Beck
authors.affiliation: HealthPartners Institute, Minneapolis, MN, USA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Rossom
authors.affiliation: Group Health Research Institute, 1730 Minor Ave. #1600, Seattle, WA, 98101, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Richards
authors.affiliation: Group Health Research Institute, 1730 Minor Ave. #1600, Seattle, WA, 98101, USA.
authors.forename: Beth
authors.initials: B
authors.lastname: Kirlin
authors.affiliation: Group Health Research Institute, 1730 Minor Ave. #1600, Seattle, WA, 98101, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: King
authors.affiliation: Group Health Research Institute, 1730 Minor Ave. #1600, Seattle, WA, 98101, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Shulman
authors.affiliation: Group Health Research Institute, 1730 Minor Ave. #1600, Seattle, WA, 98101, USA.
authors.forename: Evette J
authors.initials: EJ
authors.lastname: Ludman
authors.affiliation: Group Health Research Institute, 1730 Minor Ave. #1600, Seattle, WA, 98101, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Penfold
authors.affiliation: Group Health Research Institute, 1730 Minor Ave. #1600, Seattle, WA, 98101, USA.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Shortreed
authors.affiliation: Group Health Research Institute, 1730 Minor Ave. #1600, Seattle, WA, 98101, USA.
authors.forename: Ursula
authors.initials: U
authors.lastname: Whiteside
mesh_terms: D003120:Colorado; D003156:Community Mental Health Services; D003159:Community-Institutional Relations; D057286:Electronic Health Records; D006801:Humans; D008603:Mental Health; D010348:Patient Care Team; D011613:Psychotherapy / Q000379:methods*; D012107:Research Design; D012307:Risk Factors; D000073597:Stakeholder Participation; D013406:Suicide, Attempted / Q000517:prevention & control* / Q000523:psychology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Care management; Consent waiver; Pragmatic trial; Prevention; Suicide