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Enrolling by Invitation

NCT Number: NCT07383350

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Unit for General Practice in Aalborg

Aalborg, 9260, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARTI Info-sheets

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Proportion of patients experiencing high level of Patient-centered communication measured by CollaboRATE.

    Time frame: Day 0.

Other outcomes

  1. 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)

  2. Proportion of patients where the ARTI info-sheets were meaningful to use, as reported by healthcare professional.

    Time frame: At Initial consultation (day 0)

  3. Estimated additional meantime spent on consultation, when using ARTI Info-sheets, reported by healthcare professional.

    Time frame: At Initial consultation (day 0)

Sponsors and collaborators

Lead sponsor

Research Unit for General Practice in Aalborg

Other

Registry information

Official study title

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).

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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