AzTrials
AzTrials

DeliriumNCT04007523

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

A study testing Family Support System and HELP Support System in people with Delirium, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Delirium
What is being tested?
Family Support System and HELP Support System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
21 Nov 2019to 27 Jul 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Medical School

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): a Pilot Randomized Controlled Trial

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.

Read the 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.

Conditions
Delirium
Being tested
Family Support System, HELP Support System
Keywords
Caregivers, Clinical Decision Support Systems, Cognitive Dysfunction, Confusion, Delirium, Feasibility Studies, Geriatric Assessment, Neurocognitive Disorders
Medical subject headings
Delirium, Cognitive Dysfunction, Confusion, Neurocognitive Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Support SystemBehavioural

    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.

  • HELP Support SystemBehavioural

    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.

Study groups in NCT04007523
Study groupRoleWhat they receive
Usual Care GroupNo interventionUsual care per surgical ward standards
HELP Support SystemExperimentalThis arm will receive the HELP Support System intervention only
Receives: Behavioral: HELP Support System
Family Support SystemExperimentalThis arm will receive the Family Support system intervention only
Receives: Behavioral: Family Support System
Combined Support SystemsExperimentalParticipants randomized to this arm will receive both HELP- and family-based support system interventions
Receives: Behavioral: Family Support System; Behavioral: HELP Support System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delirium

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

    Measured: morning postoperative day one through afternoon of postoperative day three

Secondary outcomes (10)

  1. Delirium Severity

    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)

    Measured: morning postoperative day one through afternoon of postoperative day three

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

    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)

    Measured: baseline through postoperative day 2

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

    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)

    Measured: baseline through postoperative day 3

  4. Falls

    Proportion of patients in each group (%) experiencing at least one fall

    Measured: morning postoperative day one through afternoon of postoperative day three

  5. Length of Hospital Stay

    Total number of days (n) spent in the hospital, up to 30 days

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

  6. Discharge Disposition

    Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility), up to 30 days

    Measured: day of hospital discharge, up to 30 days

  7. Delayed Discharge - Cognitive Impairment

    Proportion of patients in each group (%) experiencing delayed discharge, with the documented reason as cognitive impairment

    Measured: day of hospital discharge, up to 30 days

  8. New Non-surgical Site Infection

    Incidence (%) of any new non-surgical site infection while hospitalized

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

  9. Multidrug Resistant Organism Colonization

    Incidence (%) of any new multidrug resistant organism colonization

    Measured: morning postoperative day one through 30 days after surgery

  10. Mortality

    Incidence (%)

    Measured: within 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start21 Nov 2019
  3. Primary completion27 Jul 2022
  4. Study completion27 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04007523
Sponsor's protocol ID
HUM00165251
Other IDs
5P30AG024824-15
Status last verified
Feb 2024
First submitted
27 Jun 2019
Last updated
21 Feb 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39696755

  • 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.

    PubMed 32934794

Questions about this trial

What is this clinical trial studying?

A study testing Family Support System and HELP Support System in people with Delirium, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delirium (time frame: morning postoperative day one through afternoon of postoperative day three). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04007523, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in