Population-Based Outreach Versus Usual Care to Prevent Suicide Attempt: Study Protocol for a Randomized Clinical Trial
information technology, behavioral and mental health, pragmatic trials, patient reported outcomes/functional status, clinical trials
Background: Suicide is the 10th leading cause of death. PHQ-9 item #9 (which asks about suicidal thoughts) identifies those at risk of suicide attempt/death. Patients with scores of 2 or 3 on item 9 show a sustained increase in risk, with a cumulative hazard near 4% over 12 months.
Methods: Outpatients who score a 2 or 3 on item #9 of the PHQ-9 are identified using electronic health record (EHR) data at three Mental Health Research Network sites: Group Health Cooperative, HealthPartners and Kaiser Permanente Colorado. Using a modified Zelen design, patients are automatically assigned 1:1:1 to continue in usual care (ie, no contact) or to be offered one of two population-based prevention programs meant to supplement usual care: 1) Care Management (systematic outreach to assess risk, EHR-based tools for risk-based pathways, and care management to facilitate and monitor recommended follow-up care); or 2) Skills Training (interactive online training in dialectical behavioral therapy skills supported by reminder and reinforcement messages). Randomization automatically occurs within each site’s sampling computer program, stratified by item #9 score. A computer-generated concealed allocation table provides randomly generated assignments in block sizes of either 6 or 9. The multisite interventions are embedded in the EHR. Online patient-provider secure messaging via the EHR patient portal is used for patient invitation and outreach as well as administration of suicide risk questionnaires. Secure provider-to-provider messaging is used to communicate with primary care and mental health providers. Population management and reporting tools are used to apply follow-up algorithms and deliver recommendations to care managers regarding outreach and follow-up. Nonfatal and fatal suicide attempts are identified using state vital statistics data and diagnoses of self-inflicted injury from EHR and claim records. Primary evaluation will compare risk of first suicide attempt over the 18 months following randomization. Groups will be compared according to initial treatment assignment, regardless of level of participation in either intervention.
Results: To date, 4,869 outpatients out of a planned 18,000 have been randomized across the three sites.
Conclusion: Our experience thus far illustrates the promise and challenges of implementing multisite clinical trial recruitment and intervention delivery in EHR systems.
Rossom RC, Simon G, Beck A, Richards J, Kirlin B, King D, Shulman L, Ludman E, Penfold R, Shortreed S, Whiteside U. Population-based outreach versus usual care to prevent suicide attempt: study protocol for a randomized clinical trial. J Patient Cent Res Rev. 2017;4:191-2.