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

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ClinicalTrials.gov Identifier: NCT04007523
Recruitment Status : Not yet recruiting
First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Phillip Vlisides, 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.

Condition or disease Intervention/treatment Phase
Delirium Behavioral: Family Support System Behavioral: HELP Support System Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): a Pilot Randomized Controlled Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Delirium

Arm Intervention/treatment
No Intervention: Usual Care Group
Usual care per surgical ward standards
Experimental: HELP Support System
This arm will receive the HELP Support System intervention only
Behavioral: HELP Support System
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.

Experimental: Family Support System
This arm will receive the Family Support system intervention only
Behavioral: Family Support System
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.

Experimental: Combined Support Systems
Participants randomized to this arm will receive both HELP- and family-based support system interventions
Behavioral: Family Support System
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.

Behavioral: HELP Support System
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 Outcome Measures :
  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 Outcome Measures :
  1. Delirium Severity [ Time Frame: morning postoperative day one through afternoon of postoperative day three ]
    For any patient with a positive 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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007523


Contacts
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Contact: Amy M McKinney, MA 734-647-8129 adrongo@med.umich.edu
Contact: Phillip E Vlisides, MD 734-936-4280 pvliside@med.umich.edu

Locations
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United States, Michigan
University of Michigan Medical School
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan

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Responsible Party: Phillip Vlisides, Assistant Professor of Anesthesiology, University of Michigan
ClinicalTrials.gov Identifier: NCT04007523     History of Changes
Other Study ID Numbers: HUM00165251
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Phillip Vlisides, University of Michigan:
Caregivers
Clinical Decision Support Systems
Cognitive Dysfunction
Confusion
Delirium
Feasibility Studies
Geriatric Assessment
Neurocognitive Disorders
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents