Clinical trial NCT01116076: DECISION+, a Training Program to Improve Optimal Drug Prescription
Official title: DECISION+: Une Formation Pour Les médecins de Famille Sur la Prise de décision partagée Afin d'Optimiser Les décisions Cliniques Concernant l'Utilisation d'Antibiotiques Pour Les Infections aiguës Des Voies Respiratoires (IAVR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Respiratory Infections
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 712
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Decisions about the use of antibiotics for acute respiratory infections are the most frequently reported reason for consulting a family physician. Although it varies according to the specific type of acute respiratory infections, the use of antibiotics is estimated to be 63% to 67%, well above the expected prevalence of bacterial infections thus suggesting overuse of antibiotics. Consequently, there is an urgent need for helping family physicians and their patients to improve the clinical decision making process regarding the use of antibiotics for acute respiratory infections. We will evaluate the impact of DECISION +, a multifaceted intervention program that includes training in shared decision making, reminders and feedback targeting physicians, and decision support tools targeting patients on the decision to use antibiotics for acute respiratory infections. Results from this study will lay the ground for a national strategy targeting the improvement of the clinical decision making process regarding antibiotic use for acute respiratory infections in primary care. In turn, this will increase quality of care and patient safety.


Eligibility criteria: FAMILY PHYSICIANS:

Inclusion Criteria:

* All FP (teachers and residents) providing care in the walk-in clinic in each Family Practice Teaching Unit (FPTU) will be eligible to participate in the trial.

Exclusion Criteria:

* he/she was involved or participated in the DECISION + pilot RCT
* he/she is not expected to be practicing at the FPTU for the whole duration of the study (e.g. residents ending their residency program or doing rotations outside of the FPTU, planned pregnancy/delivery, planned retirement).

PATIENTS:

Inclusion Criteria:

* if 17 years old and under, must be accompanied by a parents or a guardians)
* they are consulting a participating physician for an ARI, for which treatment with an antibiotic is considered
* they are able (patients or the accompanying parent or guardians) to read, understand and write French (expected level: 8th grade)
* they give informed consent

Exclusion Criteria:

* Patients with a condition requiring emergency care will be excluded.

Primary outcomes:
measure: Proportion of patients reporting a decision for "immediate antibiotics."
timeFrame: After index consultation
Secondary outcomes:
measure: Decision to use antibiotics
timeFrame: After index consultation
measure: Decisional conflict
timeFrame: After index consultation
measure: Adherence to the decision that was made
timeFrame: 2 weeks after the index consultation
measure: Decisional regret
timeFrame: 2 weeks after the index consultation
measure: Quality of life (QOL)
timeFrame: Baseline and 2 weeks after the index consultation
measure: Intention to engage in SDM in future consultations dealing with antibiotic use for ARI
timeFrame: Baseline and 2 weeks after the index consultation
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre Hospitalier Université Laval - Hôpital St-François d'Assise
Study officials:
References:
citation: Legare F, Labrecque M, Godin G, LeBlanc A, Laurier C, Grimshaw J, Castel J, Tremblay I, Fremont P, Cauchon M, Lemieux K, Rheaume C. Training family physicians and residents in family medicine in shared decision making to improve clinical decisions regarding the use of antibiotics for acute respiratory infections: protocol for a clustered randomized controlled trial. BMC Fam Pract. 2011 Jan 26;12:3. doi: 10.1186/1471-2296-12-3.
citation: Legare F, Labrecque M, Cauchon M, Castel J, Turcotte S, Grimshaw J. Training family physicians in shared decision-making to reduce the overuse of antibiotics in acute respiratory infections: a cluster randomized trial. CMAJ. 2012 Sep 18;184(13):E726-34. doi: 10.1503/cmaj.120568. Epub 2012 Jul 30.
citation: Legare F, Guerrier M, Nadeau C, Rheaume C, Turcotte S, Labrecque M. Impact of DECISION + 2 on patient and physician assessment of shared decision making implementation in the context of antibiotics use for acute respiratory infections. Implement Sci. 2013 Dec 26;8:144. doi: 10.1186/1748-5908-8-144.
citation: Guerrier M, Legare F, Turcotte S, Labrecque M, Rivest LP. Shared decision making does not influence physicians against clinical practice guidelines. PLoS One. 2013 Apr 24;8(4):e62537. doi: 10.1371/journal.pone.0062537. Print 2013.