DÉCISION+, a Continuous Professional Development Program to Improve Optimal Drug Prescription : a Feasibility Study

This study has been completed.
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
Conseil du Médicament du Québec
Information provided by:
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT00354315
First received: July 18, 2006
Last updated: February 13, 2009
Last verified: July 2008

July 18, 2006
February 13, 2009
September 2006
March 2008   (final data collection date for primary outcome measure)
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 ]
  • feasibility of main study based on proportion of contacted group practice that agree to participate
  • proportion of recruited physicians that participate to the workshops
  • level of satisfaction about the workshop
  • and proportion of missing data in each survey.
Complete list of historical versions of study NCT00354315 on ClinicalTrials.gov Archive Site
  • 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 ]
  • inter and intra group comparisons of diagnosis and therapeutic knowledge and skills measured with clinical vignettes
  • shared decision making measured by agreement between Decision Conflict Scale scores of physician and patient
  • socio-cognitive determinants of behaviours
  • prescription profile
  • and cost estimate of the program.
Not Provided
Not Provided
 
DÉCISION+, a Continuous Professional Development Program to Improve Optimal Drug Prescription : a Feasibility Study
DÉCISION+, a Continuous Professional Development Program to Improve Optimal Drug Prescription : a Feasibility Study

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.

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:

  1. Interactive workshops
  2. Reminders of expected behaviors
  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
  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..

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Choice Behavior
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.
  • Experimental: 1
    Immediate Continuous medical education (CME)
    Intervention: Behavioral: Continuous medical education (CME)
  • No Intervention: 2
    control, 6 months delay CME intervention
Légaré F, Labrecque M, Leblanc A, Thivierge R, Godin G, Laurier C, Côté L, O'Connor AM, Allain-Boulé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
642
March 2008
March 2008   (final data collection date for primary outcome measure)

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).

Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00354315
CRCHUQ-5-05-12-03, FRSQ-051711
No
France Légaré and Michel Labrecque, Centre hospitalier universitaire de Québec
Centre Hospitalier Universitaire de Québec, CHU de Québec
  • Fonds de la Recherche en Santé du Québec
  • Conseil du Médicament du Québec
Principal Investigator: Michel Labrecque, MD Centre Hospitalier Universitaire de Québec, CHU de Québec
Principal Investigator: France Légaré, MD Centre Hospitalier Universitaire de Québec, CHU de Québec
Centre Hospitalier Universitaire de Québec, CHU de Québec
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP