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Routine Prescription Feedback and Peer Comparison to Lower Antibiotic Prescriptions in Primary Care

Primary Purpose

Upper Respiratory Tract Infections, Urinary Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Antibiotic prescription feedback
No Feedback
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Upper Respiratory Tract Infections focused on measuring antibiotic, prescription rate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Board certified physicians with a certificate from the Swiss Medical Association (Facharzttitel' General Internal Medicine, Subspecialities in Internal Medicine, Paediatrics) with an own ZAHLSTELLENREGISTER NUMBER (Konkordatsnummer).
  • At least 100 patients enlisted with the specified social health insurance providers (SANTÉSUISSE DATENPOOL AND TARIFPOOL). (to avoid classifying physicians as high prescribers who only see a small number of patients and describe antibiotics to many of them)
  • Prescription-rates of antibiotics (DDD per 100 consultations) - that are prescribed to patients enlisted with the specified social health insurance providers (SANTÉSUISSE TARIFPOOL)
  • are in the upper median of the prescription number distribution in the year prior to the start of the trial.

Exclusion Criteria:

  • Physicians with no own "Zentralstellenregister" (ZSR) number (practice fellows or substitutes, medical trainees in general practices).
  • Physicians working in institutions without own but with institutional ZSR NUMBER (ambulatory care facilities of University Hospitals, permanence, practices or Health Maintenance Organisation (HMO) with group ZSR number).

Sites / Locations

  • Switzerland

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

No feedback

Antibiotic prescription feedback

Arm Description

Physicians in the control group will only be monitored for their antibiotic prescription rates (Physicians are unaware of the trial).

Physicians receive quarterly electronic feedback on their antibiotic prescriptions

Outcomes

Primary Outcome Measures

Prescription rate of antibiotics as defined daily doses (DDD) per 100 consultations

Secondary Outcome Measures

Costs-savings from the intervention
Rate of physicians rating that the continuous update on antibiotic prescription data is useful
Percentage of prescriptions fulfilling disease-specific quality indicators for outpatient antibiotic criteria by the European Surveillance of Antimicrobial Consumption (ESAC).
Number of logins into the web-application

Full Information

First Posted
August 24, 2012
Last Updated
May 11, 2016
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01773824
Brief Title
Routine Prescription Feedback and Peer Comparison to Lower Antibiotic Prescriptions in Primary Care
Official Title
Routine Prescription Feedback and Peer Comparison to Lower Antibiotic Prescriptions in Primary Care - a Pragmatic Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effect of a continuous postal and web-based feedback and peer comparison system of individual antibiotic prescription rates on the prescription behaviour of primary care physicians in Switzerland.
Detailed Description
Background: Excessive use of antibiotics may lead to unnecessary adverse events and raise the emergence of bacterial resistance, an increasingly serious problem in Europe. In absolute terms most antibiotics are prescribed in primary care with considerable unexplained variation of antibiotic use indicating the need for further important improvement of prescription practice in Switzerland. Aim: To evaluate the effect of a continuous postal and web-based feedback and peer comparison system of individual antibiotic prescription rates on the prescription behaviour of primary care physicians in Switzerland. Design: Randomized, controlled, pragmatic intervention trial. Setting: Primary care providers of Switzerland above the median of antibiotic prescription rates. Population: Primary care physicians caring for patients enlisted with social health insurance companies that provide invoice data to the SANTÉSUISSE DATENPOOL AND TARIFPOOL. Endpoints: Primary endpoint: Prescription rate of antibiotics as defined daily doses (DDD) per 100 consultations at 12 and 24 months. Secondary endpoints: Costs-savings from the intervention, acceptability of the program, percentage of prescriptions fulfilling disease-specific quality indicators for outpatient antibiotic criteria by the European Surveillance of Antimicrobial Consumption (ESAC). Intervention: Quarterly postal and electronic feedback for 24 months on the crude number of antibiotics prescribed, a population adjusted benchmark-profile in comparison to other primary care physicians, and evidence-based guidelines for the use of antibiotics in primary care. Physicians in the control group receive no information. Variables and measurement: Rates of antibiotic prescriptions overall and per drug class (DDD), cost of prescribed drugs and the intervention program; number of web-application logins and participation cancellations, and - in a sub-sample - number of prescriptions fulfilling disease-specific quality indicators for outpatient antibiotic criteria (ESAC). Expected results: We expect a 5% reduction of antibiotic prescription rates between the intervention and control groups after 12 months with an assumed participation rate (at least one web-access) and return of acceptance questionnaire of 30%. We expect that the intervention program will be cost-saving. ESAC quality indicators will be a useful tool for monitoring the quality of antibiotic prescription in ambulatory care in Switzerland. Analyses: Analysis will be done by intention to treat principles. We will use linear regression analysis to determine the difference in antibiotic prescriptions between the intervention and the control group with appropriate adjustment for the case mix of patient populations and self-dispensation. Based on outpatient data of 2009 from the Helsana insurance and conservative effect estimates a sample-size of 1427 physicians each for the intervention and control group is planned. Significance: This trial will investigate if a repeated feedback system results in a long-term reduction of antibiotic prescription practices. In addition, the feasibility of a web-based interface as communication tool to primary care physicians will be assessed. If effective, the system could be easily employed for other interventions as well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections, Urinary Tract Infections
Keywords
antibiotic, prescription rate

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No feedback
Arm Type
Other
Arm Description
Physicians in the control group will only be monitored for their antibiotic prescription rates (Physicians are unaware of the trial).
Arm Title
Antibiotic prescription feedback
Arm Type
Experimental
Arm Description
Physicians receive quarterly electronic feedback on their antibiotic prescriptions
Intervention Type
Behavioral
Intervention Name(s)
Antibiotic prescription feedback
Other Intervention Name(s)
Active physician benchmarking
Intervention Description
Monthly postal and electronic feedback on antibiotic prescription rates
Intervention Type
Behavioral
Intervention Name(s)
No Feedback
Other Intervention Name(s)
Controls
Intervention Description
Physicians in the control group will only be monitored for their antibiotic prescription rates (Physicians are unaware of the trial)
Primary Outcome Measure Information:
Title
Prescription rate of antibiotics as defined daily doses (DDD) per 100 consultations
Time Frame
at 12 and 24 months
Secondary Outcome Measure Information:
Title
Costs-savings from the intervention
Time Frame
at 24 months
Title
Rate of physicians rating that the continuous update on antibiotic prescription data is useful
Time Frame
at 24 months
Title
Percentage of prescriptions fulfilling disease-specific quality indicators for outpatient antibiotic criteria by the European Surveillance of Antimicrobial Consumption (ESAC).
Time Frame
at 24 months
Title
Number of logins into the web-application
Time Frame
at 24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Board certified physicians with a certificate from the Swiss Medical Association (Facharzttitel' General Internal Medicine, Subspecialities in Internal Medicine, Paediatrics) with an own ZAHLSTELLENREGISTER NUMBER (Konkordatsnummer). At least 100 patients enlisted with the specified social health insurance providers (SANTÉSUISSE DATENPOOL AND TARIFPOOL). (to avoid classifying physicians as high prescribers who only see a small number of patients and describe antibiotics to many of them) Prescription-rates of antibiotics (DDD per 100 consultations) - that are prescribed to patients enlisted with the specified social health insurance providers (SANTÉSUISSE TARIFPOOL) are in the upper median of the prescription number distribution in the year prior to the start of the trial. Exclusion Criteria: Physicians with no own "Zentralstellenregister" (ZSR) number (practice fellows or substitutes, medical trainees in general practices). Physicians working in institutions without own but with institutional ZSR NUMBER (ambulatory care facilities of University Hospitals, permanence, practices or Health Maintenance Organisation (HMO) with group ZSR number).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiner C Bucher, Prof Dr med
Organizational Affiliation
Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Widmer, Prof Dr med
Organizational Affiliation
Klinik für Infektiologie und Spitalhygiene, University Hospital Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Zeller, PD Dr med
Organizational Affiliation
Institut für Hausarztmedizin, University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Switzerland
City
Basel
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28027333
Citation
Hemkens LG, Saccilotto R, Reyes SL, Glinz D, Zumbrunn T, Grolimund O, Gloy V, Raatz H, Widmer A, Zeller A, Bucher HC. Personalized Prescription Feedback Using Routinely Collected Data to Reduce Antibiotic Use in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 1;177(2):176-183. doi: 10.1001/jamainternmed.2016.8040.
Results Reference
derived
PubMed Identifier
27530528
Citation
Hemkens LG, Saccilotto R, Reyes SL, Glinz D, Zumbrunn T, Grolimund O, Gloy V, Raatz H, Widmer A, Zeller A, Bucher HC. Personalized prescription feedback to reduce antibiotic overuse in primary care: rationale and design of a nationwide pragmatic randomized trial. BMC Infect Dis. 2016 Aug 17;16:421. doi: 10.1186/s12879-016-1739-0.
Results Reference
derived
Links:
URL
http://ihamb.unibas.ch
Description
Institut für Hausarztmedizin der Universität Basel
URL
http://www.swissnoso.ch
Description
Swiss Society for Nosocomial Infections

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Routine Prescription Feedback and Peer Comparison to Lower Antibiotic Prescriptions in Primary Care

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