Respiratory tract infections in primary care

• Register: ISRCTN
• Last refreshed on: 25 July 2023
• Main ID: ISRCTN15061174
• Date of registration: 08/06/2018
• Prospective Registration: No
• Primary sponsor: Federal Office of Administration
• Public title: Respiratory tract infections in primary care
• Scientific title: Converting Habits of Antibiotic Use for Respiratory Tract Infections in German Primary Care
• Date of first enrolment: 01/08/2017
• Target sample size: 11000
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN15061174
• Study type: Interventional
• Study design: Current study design as of 13/07/2018: Public campaign: population-related intervention Nested cRCT: nested two-arm cluster-randomized controlled trial Process evalaution: embedded into cluster-randomized controlled trial Previous study design: Public campaign: population-related intervention Nested cRCT: nested two-arm cluster-randomized controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Germany

Contacts

• Name: Attila Altiner

Key inclusion & exclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 13/07/2018:
Public campaign: not applicable given the design of the study.

Nested cRCT:
1. Patients of >17 years
2. Consult their GP for an acute respiratory tract infection

Process evaluation:
1. Participants >18 years
2. Full command of German language

Previous participant inclusion criteria:
Public campaign: not applicable given the design of the study.

Nested cRCT:
1. Patients of >17 years
2. Consult their GP for an acute respiratory tract infection
Exclusion criteria: Current participant exclusion criteria as of 13/07/2018:
Public campaign: not applicable given the design of the study.

Nested cRCT:
1. Deficient knowledge of the German language
2. Any form of dementia

Process evaluation:
1. Deficient knowledge of German language
2. Mentally incapacitated
3. Less than 18 years old

Previous participant exclusion criteria:
Public campaign: not applicable given the design of the study.

Nested cRCT:
1. Deficient knowledge of the German language
2. Any form of dementia

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Respiratory tract infection (RTI)
Respiratory
Respiratory tract infection (RTI)

Intervention(s)

Current interventions as of 13/07/2018:
Public campaign:
Spread of information for and against antibiotic prescribing via media, like posters, special website or handouts. The campaign starts in September 2018 and lasts until the end of the trial in January 2020. However, online information on treating ARTI and antibiotics will be available even after the trial.

Nested cRCT
Clusters consist of participating primary care physicians and their patients. After recruitment, GP surgeries are randomized into intervention and control group. Randomization is stratified by antibiotic prescription rate of the GP.

1. Intervention: The intervention focuses on GP surgeries, including both GPs as well as medical assistants. GP surgeries receive practice-specific antibiotic prescribing-feedback and E-Learning modules with doctor-patient and nurse-patient communication training as focal points. The latter includes communication strategies e.g. on how to handle patients expecting the prescription of antibiotics. Both, the feedback and the E-Learning modules are delivered and discussed during a practice visit performed by outreach visitors. Furthermore, during their wait at the practice, patients of the intervention group are offered tablet computers with multimedia information material on antibiotics and the treatment of ARTI. The material is tailored to different groups of patients e.g. parents of children with ARTI, or elderly. Communication designers are involved in developing appealing material.

2. Control (care as usual):
Data collection of the antibiotic prescriptions takes place at the beginning of the trial, during the intervention and after the intervention for both study arms. This data is retrieved in a pseudonymised way from the German statutory health insurance company AO

Primary Outcome(s)

Public campaign:
Prescription rate of antibiotics for acute respiratory tract infections is assessed using data from the AOK health insurance company for all GPs in both German regions, before and after the intervention.

Nested cRCT:
GPs prescription rate of antibiotics for acute respiratory infections is assessed from the data of the AOK health insurance company before and after the intervention.

Secondary Outcome(s)

Public campaign and Nested cRCT:
1. Antibiotics usage per 1000 citizens and day is measured from the data of the AOK health insurance company before and after the intervention.
2. Choice of active ingredient (broad- vs. narrow-spectrum antibiotics) is measured from the data of the AOK health insurance company before and after the intervention.
3. Number of patients with ARTI without antibiotic prescription is measured from the data of the AOK health insurance company before and after the intervention.
4. Number of patients with ARTI with recommended antibiotic prescription is measured from the data of the AOK health insurance company before and after the intervention.

Secondary ID(s)

ZMVI1-2516FSB100

Source(s) of Monetary Support

Bundesministerium für Gesundheit

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Current ethics approval as of 13/07/2018: 1. Public campaign: Ethics committee at the Rostock University Medical Centre, 04/09/2017, ref: A 2017-0134 2. Nested cRCT: Ethics committee at the Rostock University Medical Centre, 29/09/2017, ref: A 2017-0162 3. Process evaluation: Ethics committee at the Medical Faculty, Heidelberg, 11/06/2018, ref. S-349/2018 Previous ethics approval: 1. Public campaign: Ethics committee at the Rostock University Medical Centre, 04/09/2

Results

• Results available: Yes
• Date Completed: 31/01/2020