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

• ClinicalTrials.gov Identifier: NCT00354315
• Recruitment Status: Completed
• First Posted: July 20, 2006
• Last Update Posted: February 16, 2009
• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: Fonds de la Recherche en Santé du Québec; Conseil du Médicament du Québec
• Information provided by: CHU de Quebec-Universite Laval

Tracking Information

• First Submitted Date: July 18, 2006
• First Posted Date: July 20, 2006
• Last Update Posted Date: February 16, 2009
• Study Start Date: September 2006
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 29, 2007): 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 (submitted: July 18, 2006)

• 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.

Current Secondary Outcome Measures (submitted: November 29, 2007)

• decision to use antibiotics [ Time Frame: one year ]
• decisional conflict [ Time Frame: one year ]
• decisional regret [ Time Frame: one year ]
• prescription profile of antibiotics in ARI [ Time Frame: 18 months ]
• script concordance test [ Time Frame: one year ]
• physician' reactions to uncertainty [ Time Frame: 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 ]

Original Secondary Outcome Measures (submitted: July 18, 2006)

• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)
• Condition: Choice Behavior

Intervention

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.

Study Arms

• Experimental: 1
  Immediate Continuous medical education (CME)
  Intervention: Behavioral: Continuous medical education (CME)
• No Intervention: 2
  control, 6 months delay CME intervention

Publications *

• 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.
• Leblanc A, Légaré F, Labrecque M, Godin G, Thivierge R, Laurier C, Côté 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 16, 2008): 642
• Original Enrollment (submitted: July 18, 2006): 486
• Actual Study Completion Date: March 2008
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00354315
• Other Study ID Numbers: CRCHUQ-5-05-12-03; FRSQ-051711
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: France Légaré and Michel Labrecque, Centre hospitalier universitaire de Québec
• Study Sponsor: CHU de Quebec-Universite Laval

Collaborators

• Fonds de la Recherche en Santé du Québec
• Conseil du Médicament du Québec

Investigators

• Principal Investigator: Michel Labrecque, MD; CHU de Quebec-Universite Laval
• Principal Investigator: France Légaré, MD; CHU de Quebec-Universite Laval

• PRS Account: CHU de Quebec-Universite Laval
• Verification Date: July 2008