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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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