NCT03776383

Brief Summary

Antibiotic overuse occurs in multiple jurisdictions and is associated with rising rates of antimicrobial resistance. Mailing letters to the highest antibiotic prescribing physicians is a potentially effective method to optimize antibiotic use. The objectives of this study are to improve enrollment to Health Quality Ontario's Primary Care Practice report and reduce unnecessary antibiotic use. The investigators are conducting a randomized controlled trial recruiting the 3500 highest antibiotic prescribing primary care physicians in Ontario. The investigators have incorporated behavioural science theory into designing letters to modify prescribing behaviour. Letter 1 is testing change ideas related to antibiotic initiation and letter 2 is testing change ideas related to antibiotic duration. There will be 1500 physicians receiving letter 1, 1500 receiving letter 2, and 500 will serve as controls. Twelve months later all 3500 physicians will receive a letter.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 14, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

December 12, 2018

Last Update Submit

March 2, 2021

Conditions

Keywords

Antibiotic useAudit and feedbackimplementation scienceAntimicrobial stewardship

Outcome Measures

Primary Outcomes (2)

  • Antibiotic prescribing rate

    Number of antibiotics prescribed per 100 total prescriptions

    12 months

  • Prolonged duration prescribing rate

    Proportion of antibiotic prescriptions that are \>7 days per 100 total prescriptions

    12 months

Secondary Outcomes (1)

  • New enrollment for Health Quality Ontario primary care practice reports

    24 months

Other Outcomes (10)

  • New enrollment for Health Quality Ontario primary care practice reports

    6 months

  • New enrollment for Health Quality Ontario primary care practice reports

    12 months

  • Antibiotic prescribing rate

    3 months

  • +7 more other outcomes

Study Arms (3)

Antibiotic use feedback letter 1

ACTIVE COMPARATOR

Antibiotic use feedback letter 1 provides physicians with information on their antibiotic use plus change ideas on appropriate antibiotic prescribing for acute respiratory conditions

Other: Antibiotic use feedback letter

Antibiotic use feedback letter 2

ACTIVE COMPARATOR

Antibiotic use feedback letter 2 provides physicians with information on their antibiotic use plus change ideas on appropriate antibiotic durations for common infections

Other: Antibiotic use feedback letter

Control

NO INTERVENTION

Controls will not receive a letter

Interventions

Mailed letters indicating that the physician prescribes more antibiotics than 75% of their peers

Antibiotic use feedback letter 1Antibiotic use feedback letter 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ontario primary care physicians
  • Prescribe more antibiotics by volume than 75% of Ontario primary care physicians
  • A College of Physicians and Surgeons of Ontario number in 2017-2018

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Ontario

Toronto, Ontario, M5G 1V2, Canada

Location

Related Publications (8)

  • Hallsworth M, Chadborn T, Sallis A, Sanders M, Berry D, Greaves F, Clements L, Davies SC. Provision of social norm feedback to high prescribers of antibiotics in general practice: a pragmatic national randomised controlled trial. Lancet. 2016 Apr 23;387(10029):1743-52. doi: 10.1016/S0140-6736(16)00215-4. Epub 2016 Feb 18.

    PMID: 26898856BACKGROUND
  • 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.

    PMID: 27530528BACKGROUND
  • Nudge vs Superbugs: A behavioural economics trial to reduce the overprescribing of antibiotics, Available online at: http://behaviouraleconomics.pmc.gov.au/sites/default/files/projects/report-nudge-vs-superbugs.pdf (accessed June 27, 2018).

    BACKGROUND
  • McCullough AR, Rathbone J, Parekh S, Hoffmann TC, Del Mar CB. Not in my backyard: a systematic review of clinicians' knowledge and beliefs about antibiotic resistance. J Antimicrob Chemother. 2015 Sep;70(9):2465-73. doi: 10.1093/jac/dkv164. Epub 2015 Jun 20.

    PMID: 26093375BACKGROUND
  • Eccles MP, Grimshaw JM, Johnston M, Steen N, Pitts NB, Thomas R, Glidewell E, Maclennan G, Bonetti D, Walker A. Applying psychological theories to evidence-based clinical practice: identifying factors predictive of managing upper respiratory tract infections without antibiotics. Implement Sci. 2007 Aug 3;2:26. doi: 10.1186/1748-5908-2-26.

    PMID: 17683558BACKGROUND
  • Hrisos S, Eccles M, Johnston M, Francis J, Kaner EF, Steen N, Grimshaw J. Developing the content of two behavioural interventions: using theory-based interventions to promote GP management of upper respiratory tract infection without prescribing antibiotics #1. BMC Health Serv Res. 2008 Jan 14;8:11. doi: 10.1186/1472-6963-8-11.

    PMID: 18194527BACKGROUND
  • Pennell ML, Hade EM, Murray DM, Rhoda DA. Cutoff designs for community-based intervention studies. Stat Med. 2011 Jul 10;30(15):1865-82. doi: 10.1002/sim.4237. Epub 2011 Apr 17.

    PMID: 21500240BACKGROUND
  • Schwartz KL, Ivers N, Langford BJ, Taljaard M, Neish D, Brown KA, Leung V, Daneman N, Alloo J, Silverman M, Shing E, Grimshaw JM, Leis JA, Wu JHC, Garber G. Effect of Antibiotic-Prescribing Feedback to High-Volume Primary Care Physicians on Number of Antibiotic Prescriptions: A Randomized Clinical Trial. JAMA Intern Med. 2021 Sep 1;181(9):1165-1173. doi: 10.1001/jamainternmed.2021.2790.

Study Officials

  • Kevin Schwartz, MD MSc

    Ontario Agency for Health Protection and Promotion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data for the outcome are being provided from a third party with no involvement in the study
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 3:3:1 for intervention 1: intervention 2: control
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 14, 2018

Study Start

December 14, 2018

Primary Completion

November 30, 2019

Study Completion

November 30, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

The data are proprietary and private and cannot be shared with external parties. Study results will be aggregated for publication

Locations