NCT04812769

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2022

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

Same day

First QC Date

March 22, 2021

Last Update Submit

November 18, 2021

Conditions

Alzheimer's DementiaNursing HomesAntibioticsDementia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of antibiotic prescriptions in nursing home residents

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Two nursing homes will receive the eCARE-ID intervention

Device: eCARE-ID

Control

PLACEBO COMPARATOR

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

Other: Standard of Care

Interventions

eCARE-IDDEVICE

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
Standard of CareOTHER

Standard of care will be delivered to the control home.

Control

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may not qualify if:

  • \- Not willing to consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Manisha Juthani-Mehta, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two participating nursing homes will be assigned to the intervention. One participating nursing home will serve as a control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

April 30, 2022

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

December 1, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share