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Enrolling by invitationNCT07383350Updated Feb 3, 2026

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

An interventional study of ARTI Info-sheets in Acute Bronchitis, ACUTE SINUSITIS and Sore Throat, sponsored by Research Unit for General Practice in Aalborg. Enrolling by invitation at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Research Unit for General Practice in Aalborg · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
1,144
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Bronchitis
  • ACUTE SINUSITIS
  • Sore Throat

Keywords

  • Acute respiratory tract infections
  • Antibiotics
  • General practice
  • Patient-centered communication
  • Information sheets
03

In context

Bronchitis

156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.

This study's planned enrollment of 1,144 is above the median of 185 across 105 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

Research Unit for General Practice in Aalborg is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,144 participants (estimated)

Study arms

  • No intervention
    Usual care arm
  • Active comparator
    ARTI Info-sheets

    Other: ARTI Info-sheets

Interventions

  • OtherARTI 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.

06

What researchers measure

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)

07

Study locations

1 site
  • Research Unit for General Practice in Aalborg
    Aalborg, 9260, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07383350
Lead sponsor
Research Unit for General Practice in Aalborg
Responsible party
Sponsor
First posted
Feb 3, 2026
Start date
Jan 5, 2026
Primary completion
Apr 30, 2026 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Feb 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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