Improving Patient-centered Communication and Antibiotic Use With Information Sheets for Acute Respiratory Tract Infections: A Study Protocol

January 26, 2026 updated by: Research Unit for General Practice in Aalborg

Improving Patient-centered Communication and Antibiotic Use With Information Sheets for Acute Respiratory Tract Infections: Study Protocol for a Pragmatic Cluster Randomized Trial in Danish General Practice (INFO-ARTI).

The goal of this trial is to investigate if the use of information sheets regarding acute respiratory tract infections will lead to more rational antibiotic prescribing and increase patient-centered communication i Danish general practice.

The main questions to be answered:

  • Will the use of information sheets lower antibiotic prescribing.
  • Will the use of information sheets increase patient-centered communication.

We will compare use of information sheets in the consultation with patients with symptoms of acute respiratory tract infections to usual care (control) to find out if information sheets lower antibiotic prescribing.

Participants will be presented to the information sheets during the consultation regarding symptoms of acute respiratory tract infection.

Participants will fill in a short questionaire regarding patient-centered communication shortly after the consultation.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9260
        • Research Unit for General Practice in Aalborg

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligible patients must contact the general practice clinic with symptoms of either acute pharyngotonsillitis, acute rhinosinusitis or acute bronchitis and should be above 18 years of age.

Exclusion Criteria:

  • Prior antibiotic treatment for the current episode of acute respiratory tract infections.
  • Urgent need of hospitalization.
  • Patients who do not understand Danish.
  • Patients not listed within the general practice clinic.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care arm
Active Comparator: ARTI Info-sheets
Other: ARTI Info-sheets
ARTI Info-sheets are three information sheets design to be used together with patients contacting general practice with symptoms of acute respiratory tract infections. The information sheets is created as a dialog-tool to increase patient involvement in managing of acute respiratory tract infections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections prescribed antibiotics at initial consultation.
Time Frame: At Initial consultation (day 0)
At Initial consultation (day 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with redeemed antibiotic prescriptions within 14 days after the initial consultation.
Time Frame: Additional contact from day 0 until day 14.
Additional contact from day 0 until day 14.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with retrieval of prescribed antibiotics from the pharmacy within 14 days after the initial consultation.
Time Frame: Retrieval of prescribed antibiotic from day 0 until day 14
Retrieval of prescribed antibiotic from day 0 until day 14
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections reconsultation within 14 days after the initial consultation.
Time Frame: Reconsultation from day 0 until day 14.
Reconsultation from day 0 until day 14.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with "out of hours"-consultations within 14 days after the initial consultation.
Time Frame: Out of hours consultation from day 0 until day 14.
Out of hours consultation from day 0 until day 14.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with hospital admissions within 14 after the initial consultation.
Time Frame: Hospital admissions from day 0 until day 14.
Hospital admissions from day 0 until day 14.
Proportion of patients experiencing high level of Patient-centered communication measured by CollaboRATE.
Time Frame: Day 0.
Day 0.

Other Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with one of the ARTI Info-sheets used during the consultation, as reported by healthcare professional.
Time Frame: At Initial consultation (day 0)
At Initial consultation (day 0)
Proportion of patients where the ARTI info-sheets were meaningful to use, as reported by healthcare professional.
Time Frame: At Initial consultation (day 0)
At Initial consultation (day 0)
Estimated additional meantime spent on consultation, when using ARTI Info-sheets, reported by healthcare professional.
Time Frame: At Initial consultation (day 0)
At Initial consultation (day 0)

Collaborators and Investigators

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

Sponsor

Research Unit for General Practice in Aalborg

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 (Actual)

January 5, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 471-2

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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