Citation

Boudreaux ED, Larkin C, Sefair AV, Mick E, Clements K, Pelletier L, Yang C, Kiefe C. Contemp. Clin. Trials Commun. 2022; 30: e100999.

Copyright

(Copyright © 2022, Elsevier Publishing)

DOI

10.1016/j.conctc.2022.100999

PMID

36237289

PMCID

PMC9551075

Abstract

BACKGROUND: Suicide remains the 10th leading cause of death in the United States. Many patients presenting to healthcare settings with suicide risk are not identified and their risk mitigated during routine care. Our aim is to describe the planned methodology for studying the implementation of the Zero Suicide framework, a systems-based model designed to improve suicide risk detection and treatment, within a large healthcare system.

METHODS: We planned to use a stepped wedge design to roll-out the Zero Suicide framework over 4 years with a total of 39 clinical units, spanning emergency department, inpatient, and outpatient settings, involving ∼310,000 patients. We used Lean, a widely adopted a continuous quality improvement (CQI) model, to implement improvements using a centralize "hub" working with smaller "spoke" teams comprising CQI personnel, unit managers, and frontline staff.

RESULTS: Over the course of the study, five major disruptions impacted our research methods, including a change in The Joint Commission's safety standards for suicide risk mitigation yielding massive system-wide changes and the COVID-19 pandemic. What had been an ambitious program at onset became increasingly challenging because of the disruptions, requiring significant adaptations to our implementation approach and our study methods.

CONCLUSIONS: Real-life obstacles interfered markedly with our plans. While we were ultimately successful in implementing Zero Suicide, these obstacles led to adaptations to our approach and timeline and required substantial changes in our study methodology. Future studies of quality improvement efforts that cut across multiple units and settings within a given health system should avoid using a stepped-wedge design with randomization at the unit level if there is the potential for sentinel, system-wide events.

Language: en

Keywords

Suicide; Mental health; Suicide prevention; Implementation science; (CQI), continuous quality improvement; (ED), Emergency Department; (EHR), lectronic health record; (GIS), Geographic Information Systems; (NIMH), National Institute of Mental Health; (SOS), System of Safety; Quality improvement