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Choice BehaviorNCT00354315

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

A study testing Continuous medical education (CME) in people with Choice Behavior, run by CHU de Quebec-Universite Laval at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Choice Behavior
What is being tested?
Continuous medical education (CME)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
642 participants
Where
1 siteCanada
Study dates
Sep 2006to Mar 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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).

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre hospitalier universitaire de Québec, Hôpital Saint-François d'Assise

    Québec, Quebec, G1L 3L5

Other trials in Canada

About this 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.

Read the 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.

Conditions
Choice Behavior
Being tested
Continuous medical education (CME)
Keywords
Shared decision making, Optimal drug prescription

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous medical education (CME)Behavioural

    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 groups in NCT00354315
Study groupRoleWhat they receive
1ExperimentalImmediate Continuous medical education (CME)
Receives: Behavioral: Continuous medical education (CME)
2No interventioncontrol, 6 months delay CME intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: two years

Secondary outcomes (7)
  1. decision to use antibiotics

    Measured: one year

  2. decisional conflict

    Measured: one year

  3. decisional regret

    Measured: one year

  4. prescription profile of antibiotics in ARI

    Measured: 18 months

  5. script concordance test

    Measured: one year

  6. physician' reactions to uncertainty

    Measured: 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

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
642 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00354315
Sponsor's protocol ID
CRCHUQ-5-05-12-03
Other IDs
FRSQ-051711
Status last verified
Jul 2008
First submitted
18 Jul 2006
Last updated
16 Feb 2009
Results posted
No
Data monitoring committee
No

Publications

  • Legare F, Labrecque M, Leblanc A, Thivierge R, Godin G, Laurier C, Cote L, O'Connor AM, Allain-Boule 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. doi: 10.1186/1471-2296-8-65.

    PubMed 18047643
  • Leblanc A, Legare F, Labrecque M, Godin G, Thivierge R, Laurier C, Cote 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.

    PubMed 21241514

Questions about this trial

What is this clinical trial studying?

A study testing Continuous medical education (CME) in people with Choice Behavior, run by CHU de Quebec-Universite Laval at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00354315, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2009.

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