- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00354315
DÉCISION+, a Continuous Professional Development Program to Improve Optimal Drug Prescription : a Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Conseil du médicament du Québec defines optimal drug use as a "use that maximizes benefits and minimizes risks to population health by taking into account available options, costs and resources as well as patient values and social values". This definition appropriately recognizes the uncertainty surrounding the use of most drugs, i.e. there is often more than one good therapeutic option. The Ottawa Decision Support Framework (ODSF) guides practitioners in assessing decision-making needs in clinical practice, providing support for client decision making, and evaluating the effectiveness of their interventions. DECISION+ is an innovative continuous professional development program for physicians, based on the principles of ODSF and Evidence-Based Medicine. It integrates multiple educational - behavioral change components that aim at promoting optimal shared decision making with respect to drug prescription. The investigators hypothesize that optimal shared decision making should result in optimized prescription behaviors by the physician and optimized drug use by the patient. The objective of this pilot clinical randomized trial of DECISION+ is to evaluate the feasibility of a larger randomized clinical trial, in order to determine the efficacy of the program to promote optimal shared decision making in regards to drug prescription by physicians. This pilot evaluation of the program will focus on one clinical theme: antibiotic prescription for acute respiratory infections (ARI).
The program targets general practitioners and combines three strategies that were proven effective to improve healthcare practices:
- Interactive workshops
- Reminders of expected behaviors
- Feedbacks
Three 180-minute workshops will be held over a six-month period and will include:
- Retrieval and critical appraisal of information
- Clinical practice guidelines
- Acquisition of diagnostic skills
- Communication of risks and benefits
- Shared decision making skills
- Barriers and facilitating factors to optimal shared decision making with respect to drug prescription
Family physicians from four large group practices -the randomization unit- in the province of Québec, Canada will be randomly selected and assigned to one of the following interventions:
- Immediate DECISION+ antibiotics/ARI program
- 6-month delayed DECISION+ antibiotics/ARI program
The main outcome measure of this pilot trial is to determine the feasibility of implementing the DECISION+ program on a large scale. Feasibility will be based on the proportion of contacted group practices that agree to participate, the proportion of recruited physicians that participate in the workshops, the level of satisfaction about the workshop, and the proportion of missing data in each survey. Secondary outcomes will include measure of decision to use antibiotics, decisional conflict, decisional regret, prescription profile of antibiotics in ARI, script concordance test, physician' reaction to uncertainty and intention to engage in SDM and to use clinical practice guidelines regarding the use of antibiotics in ARI in future clinical encounters..
The investigators hypothesize that shared decision making will translate into an optimized prescription by the physician and will lead to an optimized drug use by the patient. We believe that this project will help to enhance the health of the Quebec citizen by a better drug use by the patient.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Quebec, Canada, G1L 3L5
- Centre hospitalier universitaire de Québec, Hôpital Saint-François d'Assise
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Immediate Continuous medical education (CME)
|
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.
|
No Intervention: 2
control, 6 months delay CME intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: two years
|
two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
decision to use antibiotics
Time Frame: one year
|
one year
|
decisional conflict
Time Frame: one year
|
one year
|
decisional regret
Time Frame: one year
|
one year
|
prescription profile of antibiotics in ARI
Time Frame: 18 months
|
18 months
|
script concordance test
Time Frame: one year
|
one year
|
physician' reactions to uncertainty
Time Frame: one year
|
one year
|
Intention to engage in SDM and to use clinical practice guidelines regarding the use of antibiotics in ARI in future clinical encounters
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michel Labrecque, MD, CHU de Quebec-Universite Laval
- Principal Investigator: France Légaré, MD, CHU de Quebec-Universite Laval
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CRCHUQ-5-05-12-03
- FRSQ-051711
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Choice Behavior
-
University of Paris 13Institut National de la Santé Et de la Recherche Médicale, FranceCompleted
-
CHU de Quebec-Universite LavalOttawa Hospital Research Institute; Laval UniversityCompletedDecision Making | Decision Support Techniques | Decision Aids | Choice BehaviorCanada
-
Rush University Medical CenterCompleted
-
Purdue UniversityNational Institutes of Health (NIH)Terminated
-
Ospedale Regionale Bellinzona e ValliCompletedImpact of Anesthetic Choice on Costs
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedWeight | Food Choice | Nutrition IntakeUnited States
-
Suranaree University of TechnologyCompletedFactors Determining Time Allocation of a Multiple-Choice Question ExaminationThailand
-
USDA Grand Forks Human Nutrition Research CenterCalifornia Polytechnic State University-San Luis ObispoCompletedFruit and Vegetable Intake | Child Nutrition | Healthy Food Choice | Healthy Food PreparationUnited States
-
Kaohsiung Veterans General Hospital.Completed
-
The University of Tennessee, KnoxvilleWithdrawnFeeding Behavior | Behavior | Food Habits | Behavior and Behavior MechanismsUnited States
Clinical Trials on Continuous medical education (CME)
-
University of AarhusDanish College of General Practitioners; Danish Committee for Health EducationCompleted
-
Qure Healthcare, LLCCE OutcomesCompletedDepression | Heart Failure | Pain | Hypertension | Diabetes | Osteoarthritis | AsthmaUnited States
-
Wake Forest University Health SciencesUnitedHealth GroupRecruiting
-
National Taiwan University HospitalUnknownPhysical Activity | Exercise | Metabolic Syndrome XTaiwan
-
Carrick Institute for Graduate StudiesCompleted
-
Shanxi Dayi HospitalUnknown
-
Dre Edeltraut KrögerAlzheimer Society of CanadaCompleted
-
Pham Ngoc Thach University of MedicineEnrolling by invitation
-
Huashan HospitalUnknown
-
Ming KuangSun Yat-sen UniversityUnknownMental Health