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

Sponsor
Yale University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04812769
Collaborator
Advarra (Other), National Institute on Aging (NIA) (NIH), Brown University (Other)
0
Enrollment
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: eCARE-ID
  • Other: Standard of Care
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two participating nursing homes will be assigned to the intervention. One participating nursing home will serve as a control.Two participating nursing homes will be assigned to the intervention. One participating nursing home will serve as a control.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases
Anticipated Study Start Date :
Apr 30, 2022
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Two nursing homes will receive the eCARE-ID intervention

Device: eCARE-ID
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
Placebo Comparator: Control

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

Other: Standard of Care
Standard of care will be delivered to the control home.

Outcome Measures

Primary Outcome Measures

  1. Duration of antibiotic therapy in nursing home residents [6 months]

    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

  1. Number of antibiotic prescriptions in nursing home residents [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion criteria - residence in a participating nursing home

Exclusion criteria:
  • Not willing to consent to the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yale University
  • Advarra
  • National Institute on Aging (NIA)
  • Brown University

Investigators

  • Principal Investigator: Manisha Juthani-Mehta, M.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04812769
Other Study ID Numbers:
  • 2000029812
  • RFA-IMPACT-20-P02A
  • U54AG063546
First Posted:
Mar 24, 2021
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Communicable Diseases
Infections
Dementia
Alzheimer Disease

Study Results

No Results Posted as of Dec 1, 2021