Acute BronchitisNCT07383350
Improving Patient-centered Communication and Antibiotic Use With Information Sheets for Acute Respiratory Tract Infections: A Study Protocol
A study testing ARTI Info-sheets in people with Acute Bronchitis and ACUTE SINUSITIS, run by Research Unit for General Practice in Aalborg at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bronchitis, ACUTE SINUSITIS, Sore Throat
- What is being tested?
- ARTI Info-sheets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,144 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2026to 30 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
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:
Read more
- 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
- Being tested
- ARTI Info-sheets
- Keywords
- Acute respiratory tract infections, Antibiotics, General practice, Patient-centered communication, Information sheets
- Medical subject headings
- Bronchitis, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTI Info-sheetsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care arm | No intervention | Not described |
| ARTI Info-sheets | Active comparator | Not described Receives: Other: ARTI Info-sheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections prescribed antibiotics at initial consultation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Hospital admissions from day 0 until day 14.
Proportion of patients experiencing high level of Patient-centered communication measured by CollaboRATE.
Measured: Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start5 Jan 2026
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Unit for General Practice in Aalborg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383350
- Sponsor's protocol ID
- 471-2
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No