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DÉCISION+, a Continuous Professional Development Program to Improve Optimal Drug Prescription : a Feasibility Study
This study has been completed.
Sponsors and Collaborators: Centre hospitalier universitaire de Québec
Fonds de la Recherche en Santé du Québec
Conseil du Médicament du Québec
Information provided by: Centre hospitalier universitaire de Québec
ClinicalTrials.gov Identifier: NCT00354315
  Purpose

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.


Condition Intervention
Choice Behavior
Behavioral: Continuous medical education (CME)

MedlinePlus related topics: Antibiotics
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: DÉCISION+, a Continuous Professional Development Program to Improve Optimal Drug Prescription : a Feasibility Study

Further study details as provided by Centre hospitalier universitaire de Québec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • decision to use antibiotics [ Time Frame: one year ] [ Designated as safety issue: No ]
  • decisional conflict [ Time Frame: one year ] [ Designated as safety issue: No ]
  • decisional regret [ Time Frame: one year ] [ Designated as safety issue: No ]
  • prescription profile of antibiotics in ARI [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • script concordance test [ Time Frame: one year ] [ Designated as safety issue: No ]
  • physician' reactions to uncertainty [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 642
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Immediate Continuous medical education (CME)
Behavioral: 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.
2: No Intervention
control, 6 months delay CME intervention

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. We 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: 1) interactive workshops, 2) reminders of expected behaviors, and 3) feedbacks. Three 180-minute workshops will be held over a six-month period and will include: 1) retrieval and critical appraisal of information, 2) clinical practice guidelines, 3) acquisition of diagnostic skills, 4) communication of risks and benefits, 5) shared decision making skills, and 6) 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: 1) immediate DECISION+ antibiotics/ARI program, 2) 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..

We 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354315

Locations
Canada
Centre hospitalier universitaire de Québec, Hôpital Saint-François d'Assise
Quebec, Canada, G1L 3L5
Sponsors and Collaborators
Centre hospitalier universitaire de Québec
Fonds de la Recherche en Santé du Québec
Conseil du Médicament du Québec
Investigators
Principal Investigator: Michel Labrecque, MD Centre hospitalier universitaire de Québec
Principal Investigator: France Légaré, MD Centre hospitalier universitaire de Québec
  More Information

Study protocol  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Centre hospitalier universitaire de Québec ( France Légaré and Michel Labrecque )
Study ID Numbers: CRCHUQ-5-05-12-03, FRSQ-051711
Study First Received: July 18, 2006
Last Updated: July 16, 2008
ClinicalTrials.gov Identifier: NCT00354315  
Health Authority: Canada: Health Canada

Keywords provided by Centre hospitalier universitaire de Québec:
Shared decision making
Optimal drug prescription

ClinicalTrials.gov processed this record on January 14, 2009