DECISION+, a Training Program to Improve Optimal Drug Prescription (Decision+)
30 janvier 2013 mis à jour par: France Legare, CHU de Quebec-Universite Laval
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)
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
712
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Quebec, Canada
- Centre Hospitalier Université Laval - Hôpital St-François d'Assise
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Contrôle
Soins habituels
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Expérimental: DECISION+ Program
Exposure to the Decision+ Program
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DECISION+ is a multifaceted intervention program that includes: On site course and Internet-based courses (2x120 min), reminders of expected behaviours and feedback.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Proportion of patients reporting a decision for "immediate antibiotics."
Délai: After index consultation
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After index consultation
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Decision to use antibiotics
Délai: After index consultation
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After an index consultation, we will ask patients: "Was a prescription for an antibiotic or a sample of antibiotic provided to treat an ARI (acute otitis media, acute bronchitis, acute pharyngitis, or acute rhinosinusitis)?" Possible answers will be:
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After index consultation
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Decisional conflict
Délai: After index consultation
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Will be assessed with the Decisional Conflict Scale (DCS) after the index consultation.
This questionnaire is similar for physicians and patients and includes 19 items, on a five-point Likert scale, divided into five subscales that are i)uncertainty and its modifiable deficits: ii) knowledge, iii) values clarification, iv) support and v) perception of an effective choice.
Both the physician and patient versions of the DCS have adequate psychometric properties and have the same meaning for both physicians and patients.
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After index consultation
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Adherence to the decision that was made
Délai: 2 weeks after the index consultation
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2 weeks after the index consultation, patients will be asked via a telephone interview: "What was the decision made with the FP about antibiotic use for ARI two weeks ago?" and "Have you complied with this decision?"
(yes or no).
If patients answer "no", research assistants, using an open-ended question, will inquire about the reasons and the options that were adhered to.
Interviewers will be unaware of the study group and will be instructed not to ask questions that could reveal the study group.
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2 weeks after the index consultation
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Decisional regret
Délai: 2 weeks after the index consultation
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2 weeks after the index consultation, decisional regret will be assessed in patients using the Decisional Regret Scale (DRS) via a telephone interview.
The DRS is a 5-item scale with adequate psychometric properties that correlates strongly with decision satisfaction and overall QOL.
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2 weeks after the index consultation
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Quality of life (QOL)
Délai: Baseline and 2 weeks after the index consultation
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For patients only, before and two weeks after the index consultation (via a telephone interview), QOL will be assessed using the Short Form-12 (SF-12V2 Health survey).
This questionnaire measures general health status from the patient's point of view and includes eight concepts commonly represented in health status: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and emotional and mental health.
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Baseline and 2 weeks after the index consultation
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Intention to engage in SDM in future consultations dealing with antibiotic use for ARI
Délai: Baseline and 2 weeks after the index consultation
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In FP and their patients, this intention will be assessed based on the Theory of planned behavior (TPB).
The questionnaire includes 15 items, on a 7-point Likert scale, that cover the constructs of the TPB, namely attitudes, social norm, perceived behavioral control and intention.
Patients will complete this questionnaire before and 2 weeks after the index consultation; physicians will complete it once during the baseline data collection period and after the last encounter of the post-intervention data collection period.
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Baseline and 2 weeks after the index consultation
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2010
Achèvement primaire (Réel)
1 avril 2011
Achèvement de l'étude (Réel)
1 avril 2011
Dates d'inscription aux études
Première soumission
3 mai 2010
Première soumission répondant aux critères de contrôle qualité
3 mai 2010
Première publication (Estimation)
4 mai 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
1 février 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 janvier 2013
Dernière vérification
1 janvier 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FRSQ20131
- 35247 (Autre identifiant: CHUQ)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .