title: Electronic protocol for suicide risk management in research participants.
abstract: OBJECTIVE
  To describe an electronic, telephone-delivered, suicide risk management protocol (SRMP) that is designed to guide research staff and safely triage study participants who are at risk for self-harm.
  
  
  METHODS
  We tested the SRMP in the context of the NIH-funded randomized clinical trial "Bypassing the Blues" in which 302 patients who had undergone coronary artery bypass graft surgery (CABG) were screened for depression and assessed by telephone 2-weeks following hospital discharge and at 2-, 4-, and 8-month follow-up. We programmed the SRMP to assign different risk levels based on patients' answers from none to imminent with action items for research staff keyed to each of them. We describe frequency of suicidal thinking, SRMP use, and completion of specific steps in the SRMP management process over the 8-month follow-up period.
  
  
  RESULTS
  Suicidal ideation was expressed by 74 (25%) of the 302 study participants in 139 (13%) of the 1069 blinded telephone assessments performed by research staff. The SRMP was launched in 103 (10%) of assessments, and the suicidal risk level was classified as moderate or high in 10 (1%) of these assessments, thereby necessitating an immediate evaluation by a study psychiatrist. However, no hospitalizations, emergency room visits, or deaths ascribed to suicidal ideation were discovered during the study period.
  
  
  CONCLUSIONS
  The SRMP was successful in systematically and safely guiding research staff lacking specialty mental health training through the standardized risk assessment and triaging research participants at risk for self-harm.
  
  
  BACKGROUND
  Clinicaltrials.gov Identifier: NCT00091962 (http://clinicaltrials.gov/ct2/show/NCT00091962?term=rollman+cabg&rank=1).
authors.affiliation: Division of General Internal Medicine, Center for Research on Health Care, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States. Electronic address: belnapbh@upmc.edu.
authors.forename: Bea
authors.initials: B
authors.lastname: Herbeck Belnap
authors.affiliation: Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, United States.
authors.forename: Herbert C
authors.initials: HC
authors.lastname: Schulberg
authors.affiliation: Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, United States.
authors.forename: Fanyin
authors.initials: F
authors.lastname: He
authors.affiliation: Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, United States.
authors.forename: Sati
authors.initials: S
authors.lastname: Mazumdar
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.
authors.forename: Charles F
authors.initials: CF
authors.lastname: Reynolds
authors.affiliation: Division of General Internal Medicine, Center for Research on Health Care, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Rollman
mesh_terms: D001026:Coronary Artery Bypass / Q000523:psychology*; D003863:Depression / Q000175:diagnosis* / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment; D059020:Suicidal Ideation; D013405:Suicide / Q000523:psychology; D000092864:Suicide Prevention
keywords: Clinical trial; Coronary artery bypass graft; Depression; Electronic research protocol; Suicidal ideation