Assessing the impact of physician prescribing feedback on antibiotic use for urinary tract infections
| ISRCTN | ISRCTN16938907 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16938907 |
| Secondary identifying numbers | Evaluation Protocol_EQIP UTI_ver1.2_21Nov2022 |
- Submission date
- 21/11/2022
- Registration date
- 02/12/2022
- Last edited
- 01/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The discovery of antibiotics is one of the most important advancements in modern medicine. Antibiotics are regularly used to treat infections caused by bacteria. The emergence of bacteria resistant to antibiotics is a common phenomenon. As bacterial strains increase resistance to an antibiotic, the antibiotic becomes less effective. Incorrect or inappropriate antibiotic prescribing can lead to an increase in antibacterial-resistant bacteria. Knowledge translation initiatives are needed to reduce the misuse and overuse of antibiotics. The intervention in this study provided all active family physicians in the Canadian province of British Columbia with the Education for Quality Improvement in Patient Care (EQIP) program uncomplicated acute bacterial cystitis (UAC) Portrait. The aim of this study was to determine the impact of the personal prescribing feedback portraits on family physician prescribing of antibiotics for UAC.
Who can participate?
Adult females who visited a family physician during the study period, or one-year prior to the study period, for treatment of UAC
What does the study involve?
The intervention was a personalized prescribing ‘portrait’ of a physician's individual prescribing of antibiotics to women with uncomplicated acute cystitis. The portraits were developed using de-identified data provided by the British Columbia Ministry of Health. The data consisted of PharmaNet’s ClaimsHist prescription claims, Medical Services Plan physician visits, Discharge Abstract Database hospitalization records, and patient and physician demographic information. The portraits were generated using PL/SQL, SAS, and Jaspersoft’s iReport software. Physicians were sent a registration package several months before the portraits were mailed. The registration packages contained an information letter about the EQIP program and provided the physicians with the opportunity to opt-out of EQIP or agree to a paid follow-up interview.
What are the possible benefits and risks of participating?
The possible benefits of participating in the study are contributing to the science of audit and feedback and the ability to impact prescribing behaviour changes. Possible risks of participating are minimal because the study uses secondary data from administrative databases. These data are patient-level and include anonymized information about demographics, physician billing codes, and prescription dispensing. These data will not include personally identifiable information. There is no risk of disclosure of data because the data include only encrypted identifiers, and are accessed only through the BC Ministry of Health's Secure Analysis Environment. Researchers will only use anonymous secondary data, in which individual identifiers have been encrypted by the Ministry of Health before we access the data, so the identities of patients will never be known. Results will only be reported at an aggregate or population level.
Where is the study run from?
The University of Victoria, British Columbia (Canada)
When is the study starting and how long is it expected to run for?
December 2010 to February 2013
Who is funding the study?
British Columbia Ministry of Health (Canada)
Who is the main contact?
Greg Carney, Gregory.Carney@ubc.ca (Canada)
Contact information
Scientific
University of British Columbia
210-1110 Government Street
Victoria
V8W 1Y2
Canada
 ORCID ID |
0000-0002-7438-5172 |
|---|---|
| Phone | +1 250 666 0341 |
| gregory.carney@ubc.ca |
Study information
| Study design | Interventional randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | A randomized trial assessing the impact of personalized prescribing feedback to family physicians on antibiotic prescribing for outpatient uncomplicated acute cystitis |
| Study objectives | The personal prescribing feedback portrait will be associated with an increase in nitrofurantoin prescribing, and a decrease in ciprofloxacin and TMP-SMX prescribing, in the treatment of uncomplicated acute cystitis (UAC). No change in the proportion of patients receiving no drug therapy for a diagnosis of UAC. |
| Ethics approval(s) | Approved 22/03/2010, Human Research Ethics Board, (Office of Research Services, University of Victoria, Administrative Services Building B202; +1 250 472 4545; ethics@uvic.ca), ref: none available |
| Health condition(s) or problem(s) studied | Uncomplicated acute cystitis |
| Intervention | An interdisciplinary team with expertise in antimicrobial resistance, infection disease, primary care, pharmacoepidemiology, and public health developed an educational portrait aimed to improve the quality of antimicrobial prescribing for women with uncomplicated acute cystitis (UAC) in primary care. The Education for Quality Improvement in Patient Care (EQIP) program UAC portrait contained individualized physician prescribing data with evidence-based messages based on E.coli resistance rates published by the British Columbia (BC) Centre for Disease Control. The key message stated that “nitrofurantoin is now the first-line treatment for uncomplicated acute cystitis”. A paired community design was used to study 4,833 family physicians in British Columbia. Physicians were sent a registration package several months before the portraits were mailed. The registration packages contained an information letter about the EQIP program and provided the physicians with the opportunity to opt-out of the EQIP project. An article was published in the British Columbia Medical Journal in November 2010 informing family physicians that they would soon receive a confidential portrait of their prescribing of antibiotics for urinary tract infections. Communities were paired according to the number of physicians in the community and geographic location (rural versus urban), with one community of each pair randomly assigned to early intervention (n=2417) or delayed control group (n=2416). The early intervention group received their personalized EQIP portraits by mail on December 03, 2010, and again on February 28, 2011. The delayed control group physicians were mailed their personalized EQIP portraits on February 10, 2012. The delayed control group physicians were also invited to complete a reflective activity form in exchange for continuing medical education credit. The EQIP portrait was a two-page personalized color document containing: 1. A vignette describing a common clinical encounter 2. E.coli resistance rates for ciprofloxacin, nitrofurantoin, and TMP-SMX in BC patients which supported nitrofurantoin as first-line therapy 3. A horizontal bar graph depicting each physician’s personalized first-line prescribing for cystitis in the prior year compared with the BC average and the evidence-based target 4. References and a detailed explanation of how the portrait was developed The prescribing data portraits were delivered to physicians using a method that preserved patient and physician privacy: 1. Data analysts who prepared the portraits for each physician had access to only encrypted physician identifiers 2. Separate individuals sealed the portraits with encrypted identifiers into envelopes 3. Administrative staff with access to physician names and addresses had access to portraits only after they had been sealed in envelopes 4. The British Columbia Mail Service places the sealed portraits into a second envelope and applied names and addresses by way of an address-matching key |
| Intervention type | Other |
| Primary outcome measure | Proportion of acute cystitis patients prescribed nitrofurantoin as first-line treatment, using BC Ministry of Health administrative data on physician visits and dispensed medications at community pharmacies, in the 12-month period post-intervention |
| Secondary outcome measures | Proportion of acute cystitis patients prescribed ciprofloxacin, TMP-SMX, or no treatment, using BC Ministry of Health administrative data on physician visits and dispensed medications at community pharmacies, in the 12-month period post-intervention |
| Overall study start date | 03/12/2010 |
| Completion date | 09/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 20000 Setting: We randomized 4833 family physicians by geographic location into an Early intervention arm (n=2417) and a Delayed control arm (n= 2416) |
| Total final enrolment | 23446 |
| Key inclusion criteria | Female patients who visited a family physician during the study period where the primary diagnosis code on the Medical Services Plan billing record was coded as 595.x (Cystitis). Reversed billing claims were excluded: 1. Female patients only 2. Extract Medical Service Plan claims where the first 3 digits of the ICD-9 diagnosis code are 595 (acute cystitis) 3. Aged 18 years old and over |
| Key exclusion criteria | 1. Reversed medical services billing claims from above. 2. Males 3. Aged <18 years 4. Episodes that meet “complicating” factors |
| Date of first enrolment | 03/12/2010 |
| Date of final enrolment | 09/02/2012 |
Locations
Countries of recruitment
- Canada
Study participating centre
Victoria
V8W 1Y2
Canada
Sponsor information
Government
1515 Blanshard Street
Victoria
V8W 3C8
Canada
| Phone | Not disclosed |
|---|---|
| HLTH.DataSetAccessManagement@gov.bc.ca | |
| Website | https://www2.gov.bc.ca/gov/content/health |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- British Columbia Ministry of Health, B.C. Ministry of Health
- Location
- Canada
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository through a 3rd party provider: Population Data BC (https://www.popdata.bc.ca/). Restrictions apply to the availability of these data, which were used under licence for the current study, and so are not publicly available. Participant consent was not required as only secondary anonymized administrative claims data is used. All patient and physician identifiers are anonymized. See popdata.bc.ca for ethical and legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.2 | 21/11/2022 | 29/11/2022 | No | No |
| Dataset | Data for primary outcome | 01/08/2023 | No | No | |
| Results article | 31/07/2023 | 01/08/2023 | Yes | No |
Additional files
Editorial Notes
01/08/2023: Publication reference and dataset link added.
02/12/2022: Trial's existence confirmed by the Human Research Ethics Board, University of Victoria.
