Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial

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.

Keywords: Clinical Trial Protocol; Decision Support Systems; Delirium; Feasibility Studies; Perioperative Care.

Figure 1.. CONSORT study flow diagram.

HELP = Hospital Elder Life program; CAM = Confusion Assessment Method, LTAC = Long-Term Acute Care.

Figure 2.. Pragmatic Explanatory Continuum Indicator Summary (PRECIS)-2 tool depicting where RADAR resides on the pragmatic-explanatory trial continuum.

After reviewing training materials, members of the RADAR team independently scored each of the 9 domains included in the PRECIS-2 Toolkit. For each domain, scores range from 1 to 5, with lower scores reflecting an explanatory nature, and higher scores reflecting pragmatic characteristics. Median scores are presented from all team members (n=10) that completed the PRECIS-2 toolkit scoring. The median score for each domain was either a 4 or 5, reflecting a fairly pragmatic study design overall.