Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial [version 2; peer review: 2 approved]
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 program...
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doaj-f6319661d03e4dabba9557e48bb55dc02020-11-25T03:43:32ZengF1000 Research LtdF1000Research2046-14022020-09-01810.12688/f1000research.20597.229050Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial [version 2; peer review: 2 approved]Phillip E. Vlisides0Jacqueline W. Ragheb1Aleda Leis2Amanda Schoettinger3Kim Hickey4Amy McKinney5Joseph Brooks6Mackenzie Zierau7Alexandra Norcott8Shirley Yang9Michael S. Avidan10Lillian Min11Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USADepartment of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USADepartment of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USADepartment of Social Work, Michigan Medicine, Ann Arbor, MI, 48109, USAUniversity of Michigan School of Nursing, Ann Arbor, MI, 48109, USADepartment of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USADepartment of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USADepartment of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USADepartment of Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USADepartment of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USADepartment of Anesthesiology, Washington University School of Medicine, St. Louis, MO, 63110, USAGeriatric Research Education and Clinical Care, VA Ann Arbor Healthcare System, Ann Arbor, MI, 48105, USABackground: 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.https://f1000research.com/articles/8-1683/v2 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Phillip E. Vlisides Jacqueline W. Ragheb Aleda Leis Amanda Schoettinger Kim Hickey Amy McKinney Joseph Brooks Mackenzie Zierau Alexandra Norcott Shirley Yang Michael S. Avidan Lillian Min |
spellingShingle |
Phillip E. Vlisides Jacqueline W. Ragheb Aleda Leis Amanda Schoettinger Kim Hickey Amy McKinney Joseph Brooks Mackenzie Zierau Alexandra Norcott Shirley Yang Michael S. Avidan Lillian Min Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial [version 2; peer review: 2 approved] F1000Research |
author_facet |
Phillip E. Vlisides Jacqueline W. Ragheb Aleda Leis Amanda Schoettinger Kim Hickey Amy McKinney Joseph Brooks Mackenzie Zierau Alexandra Norcott Shirley Yang Michael S. Avidan Lillian Min |
author_sort |
Phillip E. Vlisides |
title |
Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial [version 2; peer review: 2 approved] |
title_short |
Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial [version 2; peer review: 2 approved] |
title_full |
Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial [version 2; peer review: 2 approved] |
title_fullStr |
Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial [version 2; peer review: 2 approved] |
title_full_unstemmed |
Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial [version 2; peer review: 2 approved] |
title_sort |
recommendations and alerting for delirium alleviation in real-time (radar): protocol for a pilot randomized controlled trial [version 2; peer review: 2 approved] |
publisher |
F1000 Research Ltd |
series |
F1000Research |
issn |
2046-1402 |
publishDate |
2020-09-01 |
description |
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. |
url |
https://f1000research.com/articles/8-1683/v2 |
work_keys_str_mv |
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