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

November 18, 2021 updated by: Yale University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 120 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria - residence in a participating nursing home

Exclusion criteria:

- Not willing to consent to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of antibiotic therapy in nursing home residents
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of antibiotic prescriptions in nursing home residents
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Brown University
National Institute on Aging (NIA)
Advarra

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2022

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000029812
  • U54AG063546 (U.S. NIH Grant/Contract)
  • RFA-IMPACT-20-P02A (Other Grant/Funding Number: NIA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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