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

NCT04007523 | Completed Results

• 2 other identifiers: HUM001652515P30AG024824-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Caregivers; Clinical Decision Support Systems; Cognitive Dysfunction; Confusion; Delirium; Feasibility Studies; Geriatric Assessment; Neurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

• Delirium

  Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19)

  morning postoperative day one through afternoon of postoperative day three

Secondary Outcomes (10)

• Delirium Severity

  morning postoperative day one through afternoon of postoperative day three

• Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D)

  baseline through postoperative day 2

• Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A)

  baseline through postoperative day 3

• Falls

  morning postoperative day one through afternoon of postoperative day three

• Length of Hospital Stay

  morning of surgery until day of hospital discharge, up to 30 days

Other Outcomes (11)

• HELP - Duration of Time

  postoperative day one through postoperative day three

• HELP - Visitation

  postoperative day one through postoperative day three

• HELP - Time to Evaluation

  postoperative day one through postoperative day three

Study Arms (4)

Usual Care Group

NO INTERVENTION

Usual care per surgical ward standards

HELP Support System

EXPERIMENTAL

This arm will receive the HELP Support System intervention only

Behavioral: HELP Support System

Family Support System

EXPERIMENTAL

This arm will receive the Family Support system intervention only

Behavioral: Family Support System

Combined Support Systems

EXPERIMENTAL

Participants randomized to this arm will receive both HELP- and family-based support system interventions

Behavioral: Family Support System; Behavioral: HELP Support System

Interventions

Family Support System BEHAVIORAL

Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.

Combined Support Systems; Family Support System

HELP Support System BEHAVIORAL

A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.

Combined Support Systems; HELP Support System

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• The Claude D. Pepper Older Americans Independence Centers: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Vlisides PE, Runstadler N, Martinez S, Ragheb JW, Mentz G, Leis A, Schoettinger A, Hickey K, McKinney A, Brooks J, Zierau M, Norcott A, Mody L, Inouye SK, Avidan MS, Min L. Feasibility of Alerting Systems and Family Care Partner Support for Postoperative Delirium Prevention. J Neurosurg Anesthesiol. 2025 Oct 1;37(4):361-370. doi: 10.1097/ANA.0000000000001016. Epub 2024 Dec 19.

  PMID: 39696755 DERIVED

• Vlisides PE, Ragheb JW, Leis A, Schoettinger A, Hickey K, McKinney A, Brooks J, Zierau M, Norcott A, Yang S, Avidan MS, Min L. Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial. F1000Res. 2019 Sep 24;8:1683. doi: 10.12688/f1000research.20597.2. eCollection 2019.

  PMID: 32934794 DERIVED

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Confusion; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Dr. Phillip Vlisides
• Organization: Michigan Medicine

pvliside@med.umich.edu

734-936-4280

Study Officials

• Phillip E Vlisides, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 5, 2019
• Study Start: November 21, 2019
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: February 21, 2024
• Results First Posted: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)