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Completed

NCT Number: NCT00354315

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire de Québec, Hôpital Saint-François d'Assise

Québec, Quebec, G1L 3L5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Continuous medical education (CME)

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. decision to use antibiotics

    Time frame: one year

  2. decisional conflict

    Time frame: one year

  3. decisional regret

    Time frame: one year

  4. prescription profile of antibiotics in ARI

    Time frame: 18 months

  5. script concordance test

    Time frame: one year

  6. physician' reactions to uncertainty

    Time frame: one year

  7. 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

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

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

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 20, 2006
Registry last updated
Feb 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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