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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04812769
Other study ID # 2000029812
Secondary ID RFA-IMPACT-20-P0
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 30, 2022
Est. completion date April 30, 2022

Study information

Verified date November 2021
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years to 120 Years
Eligibility Inclusion criteria - residence in a participating nursing home Exclusion criteria: - Not willing to consent to the study

Study Design


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

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Yale University Advarra, Brown University, National Institute on Aging (NIA)

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Secondary 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. 6 months
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