NCT01116076

Brief Summary

Decisions about the use of antibiotics for acute respiratory infections are the most frequently reported reason for consulting a family physician. Although it varies according to the specific type of acute respiratory infections, the use of antibiotics is estimated to be 63% to 67%, well above the expected prevalence of bacterial infections thus suggesting overuse of antibiotics. Consequently, there is an urgent need for helping family physicians and their patients to improve the clinical decision making process regarding the use of antibiotics for acute respiratory infections. We will evaluate the impact of DECISION +, a multifaceted intervention program that includes training in shared decision making, reminders and feedback targeting physicians, and decision support tools targeting patients on the decision to use antibiotics for acute respiratory infections. Results from this study will lay the ground for a national strategy targeting the improvement of the clinical decision making process regarding antibiotic use for acute respiratory infections in primary care. In turn, this will increase quality of care and patient safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
712

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2010

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

Study Start

First participant enrolled

May 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

May 3, 2010

Last Update Submit

January 30, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients reporting a decision for "immediate antibiotics."

    After index consultation

Secondary Outcomes (6)

  • Decision to use antibiotics

    After index consultation

  • Decisional conflict

    After index consultation

  • Adherence to the decision that was made

    2 weeks after the index consultation

  • Decisional regret

    2 weeks after the index consultation

  • Quality of life (QOL)

    Baseline and 2 weeks after the index consultation

  • +1 more secondary outcomes

Study Arms (2)

DECISION+ Program

EXPERIMENTAL

Exposure to the Decision+ Program

Behavioral: Decision+ program (to improve optimal drug prescription for ARI)

Control

NO INTERVENTION

Usual Care

Interventions

DECISION+ is a multifaceted intervention program that includes: On site course and Internet-based courses (2x120 min), reminders of expected behaviours and feedback.

DECISION+ Program

Eligibility Criteria

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

You may qualify if:

  • All FP (teachers and residents) providing care in the walk-in clinic in each Family Practice Teaching Unit (FPTU) will be eligible to participate in the trial.

You may not qualify if:

  • he/she was involved or participated in the DECISION + pilot RCT
  • he/she is not expected to be practicing at the FPTU for the whole duration of the study (e.g. residents ending their residency program or doing rotations outside of the FPTU, planned pregnancy/delivery, planned retirement).
  • PATIENTS:
  • if 17 years old and under, must be accompanied by a parents or a guardians)
  • they are consulting a participating physician for an ARI, for which treatment with an antibiotic is considered
  • they are able (patients or the accompanying parent or guardians) to read, understand and write French (expected level: 8th grade)
  • they give informed consent
  • Patients with a condition requiring emergency care will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Université Laval - Hôpital St-François d'Assise

Québec, Quebec, Canada

Location

Related Publications (4)

  • Legare F, Labrecque M, Godin G, LeBlanc A, Laurier C, Grimshaw J, Castel J, Tremblay I, Fremont P, Cauchon M, Lemieux K, Rheaume C. Training family physicians and residents in family medicine in shared decision making to improve clinical decisions regarding the use of antibiotics for acute respiratory infections: protocol for a clustered randomized controlled trial. BMC Fam Pract. 2011 Jan 26;12:3. doi: 10.1186/1471-2296-12-3.

    PMID: 21269509BACKGROUND
  • Legare F, Labrecque M, Cauchon M, Castel J, Turcotte S, Grimshaw J. Training family physicians in shared decision-making to reduce the overuse of antibiotics in acute respiratory infections: a cluster randomized trial. CMAJ. 2012 Sep 18;184(13):E726-34. doi: 10.1503/cmaj.120568. Epub 2012 Jul 30.

  • Legare F, Guerrier M, Nadeau C, Rheaume C, Turcotte S, Labrecque M. Impact of DECISION + 2 on patient and physician assessment of shared decision making implementation in the context of antibiotics use for acute respiratory infections. Implement Sci. 2013 Dec 26;8:144. doi: 10.1186/1748-5908-8-144.

  • Guerrier M, Legare F, Turcotte S, Labrecque M, Rivest LP. Shared decision making does not influence physicians against clinical practice guidelines. PLoS One. 2013 Apr 24;8(4):e62537. doi: 10.1371/journal.pone.0062537. Print 2013.

Related Links

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Canada Research Chair in Implementation of Shared Decision Making in Primary Care

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 4, 2010

Study Start

May 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations