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

NCT07383350 | Enrolling By Invitation

• 1 other identifier: 471-2
• Study Type: interventional
• Target: 1,144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Bronchitis; ACUTE SINUSITIS; Sore Throat

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections prescribed antibiotics at initial consultation.

  At Initial consultation (day 0)

Secondary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  Hospital admissions from day 0 until day 14.

Other Outcomes (3)

• Proportion of patients with one of the ARTI Info-sheets used during the consultation, as reported by healthcare professional.

  At Initial consultation (day 0)

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

  At Initial consultation (day 0)

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

  At Initial consultation (day 0)

Study Arms (2)

Usual care arm

NO INTERVENTION

ARTI Info-sheets

ACTIVE COMPARATOR

Other: ARTI Info-sheets

Interventions

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.

ARTI Info-sheets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Unit for General Practice in Aalborg: lead

Study Sites (1)

Research Unit for General Practice in Aalborg

Aalborg, 9260, Denmark

Location

MeSH Terms

Conditions

Bronchitis; Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: January 5, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

DK (1)