Suicide risk and REDCap: facilitating clinical trial inclusion

Considering increased rates of suicide, efforts have been focused on facilitating mental health research specifically dedicated to decreasing deaths by intentional self-harm. At the same time, notable suicide risk among those without identified mental health conditions highlight the importance of including such individuals in trials for a wide range of health conditions. To encourage enrollment of those at intermediate/high risk for suicide in both suicide prevention and more general health-related clinical trial research, a feasible and transferable strategy is needed. Such a strategy is outlined within this manuscript.

The authors used Research Electronic Data Capture (REDCap), as well as validated measures, to monitor suicide risk among individuals participating in two clinical trials (Facilitating Assessment of At-Risk Sailors using Technology [FAAST]; Implementing Computerized Cognitive Behavioral Therapies [cCBT] for Suicide Prevention and Depression among At-Risk Rural and Urban Veterans). Individuals whose responses passed a predetermined threshold triggered an automated clinical alert, which resulted in clinical outreach by members of the study team who were licensed mental health providers. Descriptive data (e.g., number of outreaches, outreach attempt at which contact was made, number of individuals never reached) from each of these studies is presented in support of the feasibility of this approach.

During the FAAST trial, there were 55 instances in which a participant's response met the clinical threshold for outreach based on responses to survey data (across 279 participants). Nearly all (n = 54 [98.2%]) of these instances resulted in a clinical outreach. In the cCBT trial, there were 200 instances (across 69 participants) in which a participant triggered a clinical alert. Outreach was triggered in 125 (62.5%) of these cases.

Methods and findings highlight a feasible strategy for monitoring suicide risk among individuals participating in clinical trials. Use of these methods would be expected to facilitate the inclusion of individuals at intermediate and high suicide risk in a wide range of studies, while also prioritizing safety. Moreover, researchers should be encouraged to identify and disseminate methods, such as those outlined, to facilitate suicide prevention among diverse at-risk cohorts interested in engaging as study participants.