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Enrolling by invitation NCT07383350

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

No phase Interventional Acute Bronchitis ACUTE SINUSITIS Sore Throat

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARTI Info-sheets.
Who it may be relevant to
Registry conditions: Acute Bronchitis, ACUTE SINUSITIS, Sore Throat. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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).

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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 outcome measures (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. [Time frame: 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]
  • 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.]
  • 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.]
  • 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.]
  • Proportion of patients experiencing high level of Patient-centered communication measured by CollaboRATE. [Time frame: Day 0.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Research Unit for General Practice in Aalborg — Aalborg

Identifiers

NCT: NCT07383350 · 471-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗