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NCT Number: NCT04007523

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

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Delirium

    Time frame: 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 outcomes

  1. Delirium Severity

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

  4. Falls

    Time frame: morning postoperative day one through afternoon of postoperative day three

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

  5. Length of Hospital Stay

    Time frame: 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

  6. Discharge Disposition

    Time frame: 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

  7. Delayed Discharge - Cognitive Impairment

    Time frame: day of hospital discharge, up to 30 days

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

  8. New Non-surgical Site Infection

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

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

  9. Multidrug Resistant Organism Colonization

    Time frame: morning postoperative day one through 30 days after surgery

    Incidence (%) of any new multidrug resistant organism colonization

  10. Mortality

    Time frame: within 30 days after surgery

    Incidence (%)

Other outcomes

  1. HELP - Duration of Time

    Time frame: postoperative day one through postoperative day three

    Cumulative length of time spent with HELP team members

  2. HELP - Visitation

    Time frame: postoperative day one through postoperative day three

    Proportion of patients successfully visited by the program

  3. HELP - Time to Evaluation

    Time frame: postoperative day one through postoperative day three

    Time until initial HELP evaluation

  4. Family Intervention - Duration of Time

    Time frame: postoperative day one through postoperative day three

    Cumulative duration of time spent with family members/caretakers at the bedside

  5. Family Intervention - Proportion of Daily Tasks Completed

    Time frame: postoperative day one through postoperative day three

    The proportion of family-based daily tasks successfully completed will be reported

  6. Family Intervention - Length of Time, Stimulating Activity

    Time frame: postoperative day one through postoperative day three

    Cumulative length of time spent on prescribed stimulating activities

  7. Agreement - FAM-CAM and Research-based CAM Assessments

    Time frame: postoperative day one through postoperative day three

    Agreement will be assessed, via Cohen's kappa, between FAM-CAM and research-based CAM assessments.

  8. 30-Day FAM-CAM Assessments

    Time frame: day after discharge through 30 days postoperatively

    Incidence (%) of positive FAM-CAM assessments post-discharge

  9. 36-Item Short Form Survey

    Time frame: 30 days after hospital discharge

    Comprehensive survey that reports on overall health, functional status, physical/mental well-being, and pains (score range, for both overall scale and domain subscales: n, 0-100, 0 = worst score and 100 = best score in relation to the general state of health and quality of life)

  10. PROMIS Cognitive Abilities (Short Form 4a)

    Time frame: 30 days postoperatively

    Subjective reporting of cognitive function

  11. Hospital Readmission

    Time frame: within 30 days after discharge

    Incidence (%) of hospital readmission

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Aging (NIA)
  • The Claude D. Pepper Older Americans Independence Centers

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2019
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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