NCT00354315

Brief Summary

The objective of this project is to evaluate the feasibility of a larger randomized trial of the efficacy of DECISION+, a continuous professional development program integrating multiple components, to promote shared decision making concerning drug prescription.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
642

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

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

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 16, 2009

Status Verified

July 1, 2008

Enrollment Period

1.5 years

First QC Date

July 18, 2006

Last Update Submit

February 13, 2009

Conditions

Choice Behavior

Keywords

Shared decision makingOptimal drug prescription

Outcome Measures

Primary Outcomes (1)

  • feasibility of a larger RCT aiming at promoting optimal shared decision making in regards to antibiotics prescription by GPs and antibiotics use by patients in acute upper respiratory infections

    two years

Secondary Outcomes (7)

  • decision to use antibiotics

    one year

  • decisional conflict

    one year

  • decisional regret

    one year

  • prescription profile of antibiotics in ARI

    18 months

  • script concordance test

    one year

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Immediate Continuous medical education (CME)

Behavioral: Continuous medical education (CME)

2

NO INTERVENTION

control, 6 months delay CME intervention

Interventions

Continuous medical education (CME)BEHAVIORAL

The intervention will be held over a 6 months period. DECISION+ is a multifaceted intervention program that includes: Interactive workshops (3x180 min), reminders of expected behaviours and feedback.

1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Physician: Family medicine group practices (Groupe de médicine familiale) of at least 12 members located in one of the two following regions: Québec and Chaudière-Appalaches, and from which at least 6 members have agreed to participate in the study. Patients : a) Adult or child consulting a participating physician for an acute respiratory infection (ARI) (i.e. otitis media, rhino-sinusitis, pharyngo-laryngitis, or acute bronchitis), b) Adult or child for whom a treatment with an antibiotic is considered by the patient himself (or guardian, if for a child) or by the physician; c) Patient skills in reading, understanding, and writing French (or guardian, if for a child) equivalent to grade 8; d) Patient (or guardian, if for a child) who can give informed consent for his participation in the study. Patient with a condition requiring emergency care and/or transfer to another care unit will be excluded (e.g.: psychiatric condition, cardiac or pulmonary conditions, a major infection).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire de Québec, Hôpital Saint-François d'Assise

Québec, Quebec, G1L 3L5, Canada

Location

Related Publications (2)

  • Legare F, Labrecque M, Leblanc A, Thivierge R, Godin G, Laurier C, Cote L, O'Connor AM, Allain-Boule N, Rousseau J, Tapp S. Does training family physicians in shared decision making promote optimal use of antibiotics for acute respiratory infections? Study protocol of a pilot clustered randomised controlled trial. BMC Fam Pract. 2007 Nov 29;8:65. doi: 10.1186/1471-2296-8-65.

    PMID: 18047643BACKGROUND

  • Leblanc A, Legare F, Labrecque M, Godin G, Thivierge R, Laurier C, Cote L, O'Connor AM, Rousseau M. Feasibility of a randomised trial of a continuing medical education program in shared decision-making on the use of antibiotics for acute respiratory infections in primary care: the DECISION+ pilot trial. Implement Sci. 2011 Jan 18;6:5. doi: 10.1186/1748-5908-6-5.

    PMID: 21241514DERIVED

Related Links

Study Officials

  • Michel Labrecque, MD

    CHU de Quebec-Universite Laval

    PRINCIPAL INVESTIGATOR

  • France Légaré, MD

    CHU de Quebec-Universite Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 20, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 16, 2009

Record last verified: 2008-07

Locations

CA(1)