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Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases (eCARE-ID)

Primary Purpose

Alzheimer's Dementia, Nursing Homes, Antibiotics

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eCARE-ID
Standard of Care
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer's Dementia

Eligibility Criteria

65 Years - 120 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria - residence in a participating nursing home

Exclusion criteria:

- Not willing to consent to the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Two nursing homes will receive the eCARE-ID intervention

    One control nursing home will receive infectious disease consultations and antibiotic stewardship services per routine practice.

    Outcomes

    Primary Outcome Measures

    Duration of antibiotic therapy in nursing home residents
    The primary outcome will be defined as the duration of antibiotic therapy in nursing home residents with AD/ADRD, measured as the total days of antibiotic therapy per 1000 resident-days among residents with ADRD.

    Secondary Outcome Measures

    Number of antibiotic prescriptions in nursing home residents
    The secondary outcome will be defined as the number of antibiotic prescriptions in nursing home residents with AD/ADRD, defined as the total number of antibiotic prescriptions per 1000 resident-days among residents with AD/ADRD.

    Full Information

    First Posted
    March 22, 2021
    Last Updated
    November 18, 2021
    Sponsor
    Yale University
    Collaborators
    Advarra, National Institute on Aging (NIA), Brown University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04812769
    Brief Title
    Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases
    Acronym
    eCARE-ID
    Official Title
    Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Principal Investigator is taking a leave of absence. Study terminated.
    Study Start Date
    April 30, 2022 (Anticipated)
    Primary Completion Date
    April 30, 2022 (Anticipated)
    Study Completion Date
    April 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    Advarra, National Institute on Aging (NIA), Brown University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Pilot study to evaluate the feasibility of a pilot embedded pragmatic cluster randomized controlled trial to reduce the duration of antibiotic therapy and number of antibiotic prescriptions in nursing home residents with AD/ADRD.
    Detailed Description
    The overall objective of the proposed investigation is to assess the feasibility of a pilot embedded pragmatic cluster randomized controlled trial (ePCT) to reduce the duration of antibiotic therapy and number of antibiotic prescriptions among nursing home residents with AD/ADRD. With the support of three independently owned and operated nursing homes that are unaffiliated with an academic medical center, we have developed the multicomponent intervention, eCARE-ID (Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases). eCARE-ID consists of three components: 1) Tele-ID video clinical consultation services for nursing home residents; 2) electronic consultation (e-consultation) services for healthcare personnel at participating nursing homes; and 3) Tele-ID video antibiotic stewardship services for healthcare personnel including pharmacists at participating nursing homes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer's Dementia, Nursing Homes, Antibiotics, Dementia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two participating nursing homes will be assigned to the intervention. One participating nursing home will serve as a control.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Two nursing homes will receive the eCARE-ID intervention
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    One control nursing home will receive infectious disease consultations and antibiotic stewardship services per routine practice.
    Intervention Type
    Device
    Intervention Name(s)
    eCARE-ID
    Intervention Description
    The intervention, eCARE-ID, consists of: 1) telehealth video clinical consultation services for nursing homes residents; 2) electronic consultation services for healthcare personnel; 3) telehealth video antibiotic stewardship services for healthcare personnel
    Intervention Type
    Other
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Standard of care will be delivered to the control home.
    Primary Outcome Measure Information:
    Title
    Duration of antibiotic therapy in nursing home residents
    Description
    The primary outcome will be defined as the duration of antibiotic therapy in nursing home residents with AD/ADRD, measured as the total days of antibiotic therapy per 1000 resident-days among residents with ADRD.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of antibiotic prescriptions in nursing home residents
    Description
    The secondary outcome will be defined as the number of antibiotic prescriptions in nursing home residents with AD/ADRD, defined as the total number of antibiotic prescriptions per 1000 resident-days among residents with AD/ADRD.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria - residence in a participating nursing home Exclusion criteria: - Not willing to consent to the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manisha Juthani-Mehta, M.D.
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases

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