NCT02927743

Brief Summary

Inappropriate use of antibiotics in primary care is associated with Development of antibiotic resistant strains. As part of a quality improvement program carried out in primary care in Uruguay, Argentina, Paraguay and Bolivia, a cluster randomized control trial was performed. The aim of the study was to assess whether the use of continuous evidence-based feedback about management of respiratory tract infections could decrease use of antibiotics in Acute bronchitis, common cold and acute otitis media.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,053

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

October 5, 2016

Last Update Submit

October 6, 2016

Conditions

Respiratory InfectionsAntibiotics

Outcome Measures

Primary Outcomes (1)

  • 20% difference in use of antibiotics in patients with suspected Acute bronchitis

    3 months

Secondary Outcomes (1)

  • 20% difference in the use of antibiotics in suspected acute otitis media

    3 months

Study Arms (2)

evidence-based online feedback

ACTIVE COMPARATOR

During three months GPs will receive weekly feedback about evidence-based management of respiratory tract infections. In order to control that they read the material, there is a questionnaire, they have to fill in every week

Behavioral: evidence-based online feedback

control

NO INTERVENTION

GPs will register data without receiving online feed-back

Interventions

evidence-based online feedbackBEHAVIORAL

GPs received during three months weekly mails about evidence-based practice and a small questionnaire to reflect about their practice and the new knowledge

evidence-based online feedback

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • General practitioners working in primary care
  • Patients with suspected respiratory tract infection

You may not qualify if:

  • Patients that have already started an antibiotic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD-MPH

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 7, 2016

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 7, 2016

Record last verified: 2016-10

Locations

DK(1)