Abstract
Background: Delirium is a common and serious complication of major surgery for older adults. Postoperative social and behavioral support (e.g., early mobilization, mealtime assistance) may reduce the incidence and impact of delirium, and these efforts are possible with proactive patient-care programs. This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery. Methods: This will be a randomized, controlled, factorial pilot trial at a large academic medical center. High-risk, non-cardiac surgery patients (≥70 years old) will be recruited. Patients will be allocated to a usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system (n=15). The primary outcome will be the presence of delirium, defined by positive long-form Confusion Assessment Method screening. Secondary outcomes will include additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures. Exploratory outcomes include the incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates. Ethics and dissemination: This trial has received approval by the University of Michigan Medical Institutional Review Board (IRBMED). Dissemination plans include presentation at scientific conferences, publication in medical journals, and distribution via educational and news media. Registration: ClinicalTrials.gov Identifier NCT04007523, registered on 7/3/2019.
Highlights
Delirium is a distressing and common surgical complication, affecting approximately 20–50% of older surgical patients[1,2]
Of the diverse prevention strategies that have been tested with variable success[7,9], one notable proactive patientcare program, the Hospital Elder Life Program (HELP), has been shown to reduce delirium incidence through social and behavioral interventions[10]
Approval was obtained from the University of Michigan Medical School Institutional Review Board (HUM00165251), and the trial has been registered at www.clinicaltrials.gov (NCT04007523). This protocol is compliant with the Consolidated Standards of Reporting Trials (CONSORT) extension for pilot and feasibility trials and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Guidelines[21,22]
Summary
Delirium is a distressing and common surgical complication, affecting approximately 20–50% of older surgical patients[1,2]. Of the diverse prevention strategies that have been tested with variable success[7,9], one notable proactive patientcare program, the Hospital Elder Life Program (HELP), has been shown to reduce delirium incidence through social and behavioral interventions (e.g., mealtime assistance, support with visual/hearing aids)[10]. Postoperative social and behavioral support (e.g., early mobilization, mealtime assistance) may reduce the incidence and impact of delirium, and these efforts are possible with proactive patient-care programs. This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery. Patients will be allocated to a usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP-
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