Delirium and neuropsychological recovery among emergency general surgery survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention

BACKGROUND: Delirium is a complex neuropsychiatric syndrome which consists of acute and varying changes in cognition and consciousness. Patients who develop delirium are at increased risk for a constellation of physical, cognitive, and psychological disabilities long after the delirium has ended. Collaborative care models integrating primary and specialty care in order to address patients with complex biopsychosocial needs have been demonstrated to improve outcomes in patients with chronic diseases. The purpose of this study is to evaluate the ability of a collaborative care model on the neuropsychologic recovery of delirium survivors following emergency surgery. METHODS: This protocol describes a multicenter (eight hospitals in three states) randomized controlled trial in which 528 patients who develop delirium following emergency surgery will be randomized to either a collaborative care model or usual care. The efficacy of the collaborative care model on cognitive, physical, and psychological recovery in these delirium survivors will then be evaluated over 18 months. DISCUSSION: This will be among the first randomized clinical trials in postoperative delirium survivors evaluating an intervention designed to mitigate the downstream effects of delirium and improve the neuropsychologic recovery after surgery. We hope that the results of this study will add to and inform strategies to improve postoperative recovery in this patient group. TRIAL REGISTRATION: ClinicalTrials.gov NCT05373017. Registered on May 12, 2022.