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Responsible Tracking and Accounting of Participant Mental Health Urgency/Emergency Responses in Substance Use Treatment Clinical Trials


Conference Paper

Revoredo, L.; Salazar, D.; Case, A.; Hart, B.

Society for Clinical Trials (SCT) Annual Conference





The Emmes Company, LLC (Emmes), acting as the Clinical Coordinating Center (CCC) and the Data and Statistics Center (DSC) for the National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) supports multi-site clinical trials involving behavioral and pharmacological interventions for substance use disorder treatment. These studies often recruit inherently vulnerable populations at increased risk for mental health disorders, including suicidal and homicidal ideation. We recently undertook a collaborative initiative to improve tracking and accounting of study site mental health urgency/emergency responses, in order to ensure that Standard Operating Procedures (SOPs) were followed for these instances, through use of a standardized electronic Case Report Form (eCRF). This presentation details the development and initial implementation of that eCRF. In response to previously identified documentation and tracking process gaps, Emmes CCC Safety Monitors, Clinical Study Managers and DSC Data Managers developed an eCRF dedicated to ensuring timely, uniform, and complete accounting of study site responses to participant mental health urgencies/emergencies. These gaps included previous studies in which participants responded to suicidality assessments in a way that necessitated that they be seen by a clinician for further evaluation but was not done. The Mental Health Follow-Up Assessment (MHA) was designed to track site responses to suicidal ideation and ensure that participants requiring follow up were provided with that care. It was later revised to distinguish between “in person” and “remote” research-participant encounters (e.g., in non-clinical facility or community settings) or virtual (e.g., video or telephonic), with in-person encounters less prevalent during the COVID-19 pandemic. Unique metrics for documenting site adherence to mental health urgency/emergency response SOPs were established, focusing on documenting timely clinician notification and/or assessment of participants during “in person” encounters and provision of local and/or national mental health “hot-line” referral resources to participants during “remote” encounters. To date, the MHA eCRF has been successfully incorporated into the data collection and monitoring frameworks for 9 CTN trials. Although MHA deployment outcome results are in the early stages of collection, successes have already been realized in terms of 1) enhancing “real time” monitoring of site responses to participant mental health urgencies/emergencies, 2) standardizing the documentation of study site responses, 3) encouraging adherence to site local mental health response SOPs, 4) improving research staff understanding of the differential responses required during “in person” vs. “remote” participant encounters, 5) facilitating collection, collation, and reporting of mental health safety monitoring data, and 6) reducing the time burdens on site research staff and Emmes safety and data monitoring teams in accomplishing these tasks. The newly developed MHA has already returned a number of the originally intended benefits. Accordingly, the CTN investigators and Emmes protocol teams look forward to expanding upon these initial successes as the conduct of additional CTN studies unfold. This fundamental process of preparing a tracking program for a required on-site task can easily be applied to other situations and instances across clinical trials and disease areas.

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