Patients, particularly those at the end of their lives, frequently receive goal-discordant care, and their surrogate decision-makers suffer long-term psychological injury. Contributors to these issues may include infrequent communication between clinicians and surrogates, failure to discuss prognosis, values, and treatment options that include comfort-focused care, and surrogates facing high-stakes decision-making while underprepared and overwhelmed psychologically and emotionally. This is a multicenter, patient-randomized efficacy trial of a multi-component intervention, versus usual care, for 370 incapacitated, critically ill adults at high risk of death or severe disability, and their surrogate decision-makers, from 7 hospitals across the United States. The intervention combines surrogate utilization of a digital Family Support Tool (FST) in real-time during their loved one's hospitalization with proactively scheduled family meetings, for which both surrogates and clinicians receive additional preparation, at set intervals during the ICU hospitalization. Those in the control arm will receive usual ICU care. Our primary outcome is patient-centeredness of care, measured using the modified Patient Perceived Patient-Centeredness of Care (PPPC) scale. Secondary outcomes include surrogates' psychological symptom burden, communication and decision quality, and patients' health resource utilization and clinical outcomes. This trial will provide robust evidence about the impact of combining the FST with increased and intentional communication, on patient, family, and health system outcomes for those hospitalized in the ICU.

Medications for opioid use disorder (MOUD) are effective in reducing opioid use, but retention to buprenorphine remains suboptimal among OUD patients. Integration of computer-based cognitive behavioral therapy (CBT4CBT) and utilization of recovery coaches (RCs), called RC+CBT4CBT-Buprenorphine, into OUD care could improve drug use and retention in care among patients taking buprenorphine. The OVERCOME II (OUD Intervention Recovery Coach CBT and OUD Medications II) study is a three-arm 1:1:1 randomized clinical trial designed to test the remotely delivered RC+CBT4CBT-Buprenorphineintervention as an adjunct to buprenorphine treatment for patients with OUD, and to compare it with both CBT4CBT-Buprenorphine alone and the treatment as usual (TAU). Patients (n=90) who have newly initiated buprenorphine in the past 90days are planned to be recruited. Comprehensive measures on demographics, various conditions/constructs, and outcomes will be collected from medical charts and survey instruments. Additionally, neurophysiological outcomes and neurocognitive inhibitory controls will be measured using the NEXUS-10-MKII physiological system with BioTrace+ software and computerized Drug Go/NoGo Task, respectively. Qualitative analysis of interviews with N=2 RCs and N=15 participants will also be conducted. The study will be the first to examine the effectiveness of the remotely delivered RC+CBT4CBT-Buprenorphine intervention on drug use (during the first 8weeks and follow-up) and retention in care, as well as on various neurophysiological and cognitive performances in comparison to CBT4CBT-Buprenorphine alone and TAU. Clinical Trial Registration: This study was registered at ClinicalTrials.gov (NCT06102200, www.clinicaltrials.gov/) on August 31, 2023, with a title, An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder (OVERCOME 2).