Condition category
Respiratory
Date applied
16/04/2018
Date assigned
08/06/2018
Last edited
31/08/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Current plain English summary as 13/07/2018:
Background and study aims
Excessive use of antibiotics in human and veterinary medicine is responsible for the worldwide rise of antibiotic resistance. Although, among both experts and non-professional it
is well known that acute respiratory tract infections (ARTI) are primarily caused by viruses, in too many cases antibiotics are prescribed, which are only effective against bacteria, not
viruses. Reasons for inadequate prescription of antibiotics in primary care include General Practitioners (GP) mistaken belief that patients would expect an antibiotic prescription and a
misleading safety culture.
This study tests:
1. whether a public campaign is able to empower the population to actively participate in the decision-making-process for or against antibiotic prescribing when visiting their GP for an
ARTI
2. whether practice-specific prescription-feedback and communication training is able to further optimize antibiotic prescribing in primary care.

Who can participate?
Nested cRCT: all patients attending their GP for acute respiratory tract infection (additional patient survey: patients aged over 17 years)

What does the study involve?
Public campaign: During the trial a public campaign informs the population about antibiotics, antibiotic resistance, and issues important for parents of children with ARTI.
Nested cRCT: During two successive winter periods participants who visit their GP because of ARTI are included. GPs are randomly allocated to one of two groups: (1) an intervention
that includes a practice-specific prescription-feedback, communication training and information material for patients or (2) control group with care as usual. Antibiotics prescribing rates are compared between these two groups.
Process evaluation: To understand mechanisms of the educational components, a process evaluation accompanies the intervention in the CHANGE-3 study.

What are the possible benefits and risks of participating?
Participants benefit from their own and their GP’s awareness of unnecessary antibiotic prescriptions and from a reduction of inappropriate antibiotic usage and related side effects.
Reducing unnecessary antibiotic prescriptions leads to decreasing rates of antibiotic resistance and is a benefit for the whole population. Participants may be at risk from undersupply with
antibiotics, although it is unlikely. Participation in the process evaluation provides a possibility to increase health literacy and to contribute to optimizing future care. Participants might view future antibiotic traeatment of patients with ARTI more critically. Probability of negative effects is considered to be low and harm to participants is not to be expected.

Where is the study run from?
1. University of Rostock (Germany)
2. University of Heidelberg (Germany)
3. University of Applied Sciences, Technology, Business and Design in Wismar (Germany),
4. AQUA-Institute for Applied Quality Improvement and Research in Health Care GmbH,
Göttingen (Germany)

When is the study starting and how long is it expected to run for?
February 2017 to January 2020

Who is funding the study?
Federal Ministry of Health (Germany)

Who is the main contact?
Prof. Attila Altiner (Scientific)
ifa.sekretariat@med.uni-rostock.de


Previous plain English summary:
Background and study aims
Excessive use of antibiotics in human and veterinary medicine is responsible for the worldwide rise of antibiotic resistance. Although, among both experts and non-professional it is well known that acute respiratory tract infections (ARTI) are primarily caused by viruses, in too many cases antibiotics are prescribed, which are only effective against bacteria, not viruses. Reasons for inadequate prescription of antibiotics in primary care include General Practitioners (GP) mistaken belief that patients would expect an antibiotic prescription and a misleading safety culture.
This study tests:
1. whether a public campaign is able to empower the population to actively participate in the decision-making-process for or against antibiotic prescribing when visiting their GP for an ARTI
2. whether practice-specific prescription-feedback and communication training is able to further optimize antibiotic prescribing in primary care.

Who can participate?
Nested cRCT: all patients attending their GP for acute respiratory tract infection (additional patient survey: patients aged over 17 years)

What does the study involve?
Public campaign: During the trial a public campaign informs the population about antibiotics, antibiotic resistance, and issues important for parents of children with ARTI.
Nested cRCT: During two successive winter periods participants who visit their GP because of ARTI are included. GPs are randomly allocated to one of two groups: (1) an intervention that includes a practice-specific prescription-feedback, communication training and information material for patients or (2) control group with care as usual.Antibiotic prescribing rates are compared between these two groups.

What are the possible benefits and risks of participating?
Participants benefit from their own and their GP’s awareness of unnecessary antibiotic prescriptions and from a reduction of inappropriate antibiotic usage and related side effects. Reducing unnecessary antibiotic prescriptions leads to decreasing rates of antibiotic resistance and is a benefit for the whole population. Participants may be at risk from undersupply with antibiotics, although it is unlikely.

Where is the study run from?
1. University of Rostock (Germany)
2. University of Heidelberg (Germany)
3. University of Applied Sciences, Technology, Business and Design in Wismar (Germany),
4. AQUA-Institute for Applied Quality Improvement and Research in Health Care GmbH, Göttingen (Germany)

When is the study starting and how long is it expected to run for?
February 2017 to January 2020

Who is funding the study?
Federal Ministry of Health (Germany)

Who is the main contact?
Prof. Attila Altiner (Scientific)
ifa.sekretariat@med.uni-rostock.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Attila Altiner

ORCID ID

Contact details

Rostock University Medical Center
Institute of General Practice
POB 100888
Rostock
18055
Germany
+49 381 494 2481
ifa.sekretariat@med.uni-rostock.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZMVI1-2516FSB100

Study information

Scientific title

Converting Habits of Antibiotic Use for Respiratory Tract Infections in German Primary Care

Acronym

CHANGE-3

Study hypothesis

Current study hypothesis as of 13/07/2018:
The CHANGE-3 trial aims at reducing unnecessary antibiotic prescriptions in primary care and at improving the quality of prescriptions for patients suffering from acute respiratory tract infection (ARTI). Quality of prescriptions is defined as choosing an appropriate antibiotic or avoiding of broad-spectrum antibiotics. The trial consists of a public campaign that shall inform the population of two German regions about the reasons for and against antibiotic prescribing. Patients shall be empowered to actively participate in the decision-making process for or against antibiotics when consulting their General Practitioner (GP) for an
ARTI. Within this trial, a cRCT will be nested: We investigate whether practice-specific prescription-feedback and communication training further optimize antibiotic prescribing. Using a mix of qualitative and quantitative research methods, the accompanying process evaluation aims at assessing reach and fidelity of the implementation pogram, its effects on daily practice of healthcare delivery to patients with ARTI and the impact of diverse context factors.

Previous study hypothesis:
The CHANGE-3 trial aims at reducing unnecessary antibiotic prescriptions in primary care and at improving the quality of prescriptions for patients suffering from acute respiratory tract infection (ARTI). Quality of prescriptions is defined as choosing an appropriate antibiotic or avoiding of broad-spectrum antibiotics. The trial consists of a public campaign that shall inform the population of two German regions about the reasons for and against antibiotic prescribing. Patients shall be empowered to actively participate in the decision-making process for or against antibiotics when consulting their General Practitioner (GP) for an ARTI. Within this trial, a cRCT will be nested: We investigate whether practice-specific prescription-feedback and communication training further optimize antibiotic prescribing.

Ethics approval

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, 04/09/2017, ref: A 2017-0134
2. Nested cRCT: Ethics committee at the Rostock University Medical Centre, 29/09/2017, ref: A 2017-0162

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Respiratory tract infection (RTI)

Intervention

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 AOK and includes all patients aged 0 to 100 years with ARTI who received medical treatment during the trial. Using this data, overall and practice-specific antibiotic prescribing rates are generated. All patients of participating practices insured with the AOK are included. In addition, over two successive winter seasons participating GP surgeries recruit up to 50 patients to fill in a questionnaire measuring patient knowledge on antibiotics and the treatment of ARTI.

3. Process evaluation:
The process evaluation will be conducted alongside the intervention using a mix of methods. In the intervention group, data collection will occur through telephone and face-to-face interviews with general practitoners, medical assistants, patients and outreach visitors as well as surveys for healthcare providers. In the control group, patient interviews and provider surveys will be used to collect data. All collected data will be pseudonymized for analysis.

Previous interventions:
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. 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 AOK and includes all patients aged 0 to 100 years with ARTI who received medical treatment during the trial. Using this data, overall and practice-specific antibiotic prescribing rates are generated. All patients of participating practices insured with the AOK are included. In addition, over two successive winter seasons participating GP surgeries recruit up to 50 patients to fill in a questionnaire measuring patient knowledge on antibiotics and the treatment of ARTI.

Intervention type

Other

Phase

Drug names

Primary outcome measure

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 measures

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.

Overall trial start date

01/02/2017

Overall trial end date

31/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Nested cRCT: 114 general practitioner practices recruit about 11,000 patients with RTI. Process evaluation: Interviews in the intervention group: 20 physicians and medical assistants, 10 patients and 5 outreach visitors. Interviews in the control group: 10 patients. Surveys: all participants in the intervention group and in the control group

Participant 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

Recruitment start date

01/08/2017

Recruitment end date

30/09/2018

Locations

Countries of recruitment

Germany

Trial participating centre

Rostock University Medical Center (lead centre)
Institute of General Practice
Rostock
18057
Germany

Trial participating centre

University Hospital of Heidelberg
Department of General Practice and Health Services Research
Heidelberg
69120
Germany

Trial participating centre

AQUA-Institute for Applied Quality Improvement and Research in Health Care GmbH
Maschmühlenweg 8-10
Göttingen
37073
Germany

Trial participating centre

University of Applied Sciences
Technology, Business and Design Department of Communication Design and Media Philipp-Müller-Straße 14
Wismar
23966
Germany

Trial participating centre

University Hospital Heidelberg
Institute of Medical Biometry and Informatics Marsilius-Arkaden Im Neuenheimer Feld 130.3, Turm West
Heidelberg
69120
Germany

Sponsor information

Organisation

Federal Office of Administration

Sponsor details

Bundesverwaltungsamt
ZMV I 1
Frau Rogler
Köln
50728
Germany
+49 22899358 5212
heike.rogler@bva.bund.de

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Bundesministerium für Gesundheit

Alternative name(s)

Federal Ministry of Health, Germany, Federal Ministry of Health, BMG

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Germany

Results and Publications

Publication and dissemination plan

Planned publication in an international peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/01/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

31/08/2018: The recruitment end date has been changed from 31/08/2018 to 30/09/2018. 13/07/2018: The following changes have been made to the trial record: 1. The plain English summary was updated. 2. The study hypothesis was updated 3. The ethics approval was updated 4. The study design was updated. 5. The interventions were updated. 6. The target number of participants was changed from "Nested cRCT: 114 general practitioners recruit about 11,000 patients with RTI" to "Nested cRCT: 114 general practitioners recruit about 11,000 patients with RTI. Process evaluation: Interviews in the intervention group: 20 physicians and medical assistants, 10 patients and 5 outreach visitors Interviews in the control group: 10 patients. Surveys: all participants in the intervention group and in the control group" 7. The participant inclusion criteria were updated 8. The participant exclusion criteria were updated 9. The recruitment end date was changed from 30/06/2018 to 31/08/2018.