Implementing a suicide risk management protocol as part of a multisite clinical trial: Findings and lessons learned

Although people with mental health disorders are more likely to die by suicide, individuals experiencing suicidality are frequently excluded from clinical trials of mental health treatment due to safety and liability concerns. This approach limits the generalizability of trial results and opportunities for intervention. This descriptive study aimed to report outcomes and lessons learned for a suicide risk management protocol implemented for participants reporting suicidal ideation in a comparative effectiveness clinical trial that enrolled patients screening positive for posttraumatic stress disorder or bipolar disorder. Specifically, we examined the proportion of trial participants reporting suicidal ideation, their chosen risk management plan, suicide attempts, and death by suicide. Also, because few studies have examined whether the survey modality of suicide screening impacts endorsement rates, we compared suicide ideation endorsement, patient demographics, and chosen risk management plans across phone and web survey modalities.

Descriptive statistics were used to report the proportion of participants in the comparative effectiveness trial who reported suicidal ideation and activated the suicide risk management protocol, as well as the chosen risk management plans for those with active suicidal ideation. Chi-square tests of independence and Fisher's exact tests were used to test for differences in demographics, screening question responses, and chosen risk management plans, respectively, between web versus phone survey modalities among those that activated the suicide risk management protocol.

Of the 1004 participants in the trial, 72% endorsed current suicidal ideation or previous suicidal behavior at baseline and activated the study's suicide risk management protocol. There were two suicide attempts in the sample (0.28%), and one of which resulted in death (0.14%). There were no statistically significant differences in SRMP activation between phone and web-based survey modalities. Among participants who activated the suicide risk management protocol and endorsed active suicidal ideation, selection of risk management plans did not vary by survey modality. Participants most frequently opted to visit their community health center (42%) or to call the National Suicide Prevention Lifeline (32%) as their chosen risk management plan.

We developed and implemented the suicide risk management protocol for a multisite clinical trial enrolling patients with complex mental health conditions. Although a higher proportion of participants activated the SRMP compared to previous trials, rates of suicide attempts and suicide deaths were low. Our findings indicated no differences in positive screening rates among trial participants and no differences in safety plan selection by survey modality among participants entering the SRMP. This suggests that similar protocols may be used to screen for and manage suicidality in clinical trials, and protocols can be administered via phone and web-based surveys.