Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR)

Not Applicable

Completed

• Conditions: Delirium
• Interventions: Behavioral: HELP Support System; Behavioral: Family Support System

• Registration Number: NCT04007523
• Lead Sponsor: University of Michigan

Brief Summary

This is a pilot randomized controlled trial that will test whether a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical patients. Decision support systems will be tested that provide targeted alerts and recommendations to the Hospital Elder Life Program and family members for delirium prevention.

Detailed Description

Delirium is a distressing and common surgical complication, affecting approximately 20-50% of older surgical patients. Postoperative delirium is associated with increased mortality, cognitive and functional decline, and healthcare resource utilization. Prevention programs have been tested with variable success, but the Hospital Elder Life Program (HELP) has consistently been demonstrated to reduce the incidence and impact of delirium. However, substantial resources are needed for program operations, and complementary support systems may help with patient triage and assessment. Family members and caretakers may be able to provide supplementary support with delirium screening and prevention via targeted, therapeutic activities. Thus, an automated postoperative paging system, which elicits additional, focused support from HELP and family members, may augment delirium prevention activities and reduce associated risk.

The primary objectives of this study are to determine whether pager-based clinical decision support systems bolster HELP- and family-based therapeutic activities. A secondary objective will be to identify facilitators and barriers to delivering therapeutic interventions for both HELP and family members. Overall, this pilot trial will test the hypothesis that a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical patients. Patients (n=60) will be randomized to one of four groups in a factorial design: usual care (n=15), HELP-based paging system (n=15), family-based paging system (n=15), or both HELP- and family-based paging system (n=15). The support systems will consist of automated pager alerts to the HELP program and/or family members and caretakers, depending on group allocation, for providing additional delirium evaluation and therapeutic prevention activities. Outcomes will include various clinical, neurocognitive, and functional measures, and performance metrics will be collected regarding HELP- and family-based interventions.

Study Timeline

• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Study Start: 2019-11-21
• Primary Completion: 2022-07-27
• Study Completion: 2022-07-27
• Results First Submitted: 2023-11-27
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Results First Posted: 2024-02-21
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥ 70 years of age
• Major non-cardiac, non-intracranial neurologic, and non-major vascular surgery
• Anticipated length of stay at least 72 hours
• At least one family member, or caretaker, available on each of the first three postoperative days for trial operations

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Exclusion Criteria

• Emergency surgery
• Severe cognitive impairment (precluding ability to perform delirium assessments)
• Planned postoperative ICU admission
• Non-English speaking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
HELP Support System	HELP Support System	This arm will receive the HELP Support System intervention only
Family Support System	Family Support System	This arm will receive the Family Support system intervention only
Combined Support Systems	Family Support System	Participants randomized to this arm will receive both HELP- and family-based support system interventions
Combined Support Systems	HELP Support System	Participants randomized to this arm will receive both HELP- and family-based support system interventions

Primary Outcome Measures

Name	Time	Method
Delirium	morning postoperative day one through afternoon of postoperative day three	Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19)

Secondary Outcome Measures

Name	Time	Method
Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D)	baseline through postoperative day 2	Incidence (%) of positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-D) (n, 0-21, 0 = normal, 21 = presence of severe depression symptoms)
Discharge Disposition	day of hospital discharge, up to 30 days	Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility), up to 30 days
Delayed Discharge - Cognitive Impairment	day of hospital discharge, up to 30 days	Proportion of patients in each group (%) experiencing delayed discharge, with the documented reason as cognitive impairment
Delirium Severity	morning postoperative day one through afternoon of postoperative day three	For any patient with a completed delirium assessment, the associated severity score will be recorded using the Confusion Assessment Method Long Form Severity Score (n, 0-19, with higher number indicating more severe delirium)
Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A)	baseline through postoperative day 3	Incidence (%) of positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-A) (n, 0-21, 0 = normal, 21 = presence of severe anxiety symptoms)
Falls	morning postoperative day one through afternoon of postoperative day three	Proportion of patients in each group (%) experiencing at least one fall
Length of Hospital Stay	morning of surgery until day of hospital discharge, up to 30 days	Total number of days (n) spent in the hospital, up to 30 days
New Non-surgical Site Infection	morning of surgery until day of hospital discharge, up to 30 days	Incidence (%) of any new non-surgical site infection while hospitalized
Multidrug Resistant Organism Colonization	morning postoperative day one through 30 days after surgery	Incidence (%) of any new multidrug resistant organism colonization
Mortality	within 30 days after surgery	Incidence (%)

Trial Locations

Locations (1)

University of Michigan Medical School; 🇺🇸 Ann Arbor, Michigan, United States