TY - JOUR
T1 - Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR)
T2 - Protocol for a pilot randomized controlled trial
AU - Vlisides, Phillip E.
AU - Ragheb, Jacqueline W.
AU - Leis, Aleda
AU - Schoettinger, Amanda
AU - Hickey, Kim
AU - McKinney, Amy
AU - Brooks, Joseph
AU - Zierau, Mackenzie
AU - Norcott, Alexandra
AU - Yang, Shirley
AU - Avidan, Michael S.
AU - Min, Lillian
N1 - Funding Information:
Grant information: The RADAR Trial is supported by the University of Michigan Claude D. Pepper Older American Independence Center (P30AG024824), Michigan Institute for Clinical and Health Research (UL1TR002240), and Department of Anesthesiology, University of Michigan Medical School.
Funding Information:
We would like to acknowledge George A. Mashour, MD, PhD, Sharon Inouye, MD, MPH, and Ann Kolanowski, PhD, RN, FAAN, for study design consultation. Additionally, we acknowledge the Michigan Institute for Clinical and Health Research and Michigan Medicine Office of Patient Experience for assistance with designing recruitment materials. We also acknowledge the Hospital Elder Life Program for permissions with the Confusion Assessment Method (Copyright 2003, Hospital Elder Life Program, LLC) and Family Confusion Assessment Method (FAM-CAM), Copyright 1988, 2011. Hospital Elder Life Program. Not to be reproduced without permission.
Publisher Copyright:
© 2020 Vlisides PE et al.
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - Clinical Trial Protocol
KW - Decision Support Systems
KW - Delirium
KW - Feasibility Studies
KW - Perioperative Care
UR - http://www.scopus.com/inward/record.url?scp=85091050600&partnerID=8YFLogxK
U2 - 10.12688/f1000research.20597.2
DO - 10.12688/f1000research.20597.2
M3 - Article
C2 - 32934794
AN - SCOPUS:85091050600
SN - 2046-1402
VL - 8
JO - F1000Research
JF - F1000Research
M1 - 1683
ER -