DÉCISION+, a Continuous Professional Development Program to Improve Optimal Drug Prescription : a Feasibility Study
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ClinicalTrials.gov Identifier: NCT00354315 |
Recruitment Status :
Completed
First Posted : July 20, 2006
Last Update Posted : February 16, 2009
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Tracking Information | |||||||
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First Submitted Date ICMJE | July 18, 2006 | ||||||
First Posted Date ICMJE | July 20, 2006 | ||||||
Last Update Posted Date | February 16, 2009 | ||||||
Study Start Date ICMJE | September 2006 | ||||||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||||
Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | DÉCISION+, a Continuous Professional Development Program to Improve Optimal Drug Prescription : a Feasibility Study | ||||||
Official Title ICMJE | DÉCISION+, a Continuous Professional Development Program to Improve Optimal Drug Prescription : a Feasibility Study | ||||||
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. | ||||||
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:
Three 180-minute workshops will be held over a six-month period and will include:
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:
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) |
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Condition ICMJE | Choice Behavior | ||||||
Intervention ICMJE | 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.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
642 | ||||||
Original Enrollment ICMJE |
486 | ||||||
Actual Study Completion Date ICMJE | March 2008 | ||||||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | 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). |
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT00354315 | ||||||
Other Study ID Numbers ICMJE | CRCHUQ-5-05-12-03 FRSQ-051711 |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | France Légaré and Michel Labrecque, Centre hospitalier universitaire de Québec | ||||||
Study Sponsor ICMJE | CHU de Quebec-Universite Laval | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | CHU de Quebec-Universite Laval | ||||||
Verification Date | July 2008 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |