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Trial of Post-Dated Delayed Antibiotic Prescriptions

Primary Purpose

Acute Upper Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
A delayed prescription dated 2 days after clinical office visit
Usual Dated
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Upper Respiratory Tract Infections focused on measuring Respiratory infections, Primary care, Antibiotics, Delayed prescriptions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults aged 18 years or older
  • Adults with an untreated upper respiratory tract infection
  • Adults presenting for the first time to a family physician or a nurse practitioner

Exclusion Criteria:

  • Less that 18 years
  • Having a clear indication for antibiotic therapy

Sites / Locations

  • Memorial University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Post-Dated Prescription

Usual

Arm Description

a delayed prescription dated 2 days after clinical office visit

usual date

Outcomes

Primary Outcome Measures

Number of Participants That Filled a Prescription in 20 Days
Prescriptions

Secondary Outcome Measures

Full Information

First Posted
May 27, 2010
Last Updated
May 3, 2021
Sponsor
Memorial University of Newfoundland
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1. Study Identification

Unique Protocol Identification Number
NCT02732847
Brief Title
Trial of Post-Dated Delayed Antibiotic Prescriptions
Official Title
Post-Dated Versus Voluntary Delayed Antibiotic Prescriptions for Acute Respiratory Infections in Primary Care: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial University of Newfoundland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract infections (which are mostly viral). This trial will test the hypothesis that if the clinician post-dates the delayed prescription by 2 days, rather than dating it on the day the patient is seen, there will be a further drop in the rate of antibiotic use.
Detailed Description
6 family doctors and 2 nurse practitioners in a small rural town will issue delayed antibiotic prescriptions to adult patients with new acute respiratory tract infections. The delayed prescriptions will be randomly dated for either the day of the office visit, or 2 days later. The 2 local pharmacies will note whether the prescription is cashed, and when. It is hypothesised that post-dating the prescription will result in a reduced cashing rate. Each arm of the study (Usual v Post-Dated) will contain 75 subjects. This sample will have the power to detect a 25% change in prescription use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Tract Infections
Keywords
Respiratory infections, Primary care, Antibiotics, Delayed prescriptions

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-Dated Prescription
Arm Type
Other
Arm Description
a delayed prescription dated 2 days after clinical office visit
Arm Title
Usual
Arm Type
Other
Arm Description
usual date
Intervention Type
Other
Intervention Name(s)
A delayed prescription dated 2 days after clinical office visit
Intervention Type
Drug
Intervention Name(s)
Usual Dated
Primary Outcome Measure Information:
Title
Number of Participants That Filled a Prescription in 20 Days
Description
Prescriptions
Time Frame
20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 18 years or older Adults with an untreated upper respiratory tract infection Adults presenting for the first time to a family physician or a nurse practitioner Exclusion Criteria: Less that 18 years Having a clear indication for antibiotic therapy
Facility Information:
Facility Name
Memorial University
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A0G 2L0
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Trial of Post-Dated Delayed Antibiotic Prescriptions

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