DECISION+, a Training Program to Improve Optimal Drug Prescription (Decision+)
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|ClinicalTrials.gov Identifier: NCT01116076|
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : February 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Infections||Behavioral: Decision+ program (to improve optimal drug prescription for ARI)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||712 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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 Start Date :||May 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: DECISION+ Program
Exposure to the Decision+ Program
Behavioral: Decision+ program (to improve optimal drug prescription for ARI)
DECISION+ is a multifaceted intervention program that includes: On site course and Internet-based courses (2x120 min), reminders of expected behaviours and feedback.
No Intervention: Control
- Proportion of patients reporting a decision for "immediate antibiotics." [ Time Frame: After index consultation ]
- Decision to use antibiotics [ Time Frame: After index consultation ]
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:
- Yes,(Immediate antibiotics);
- Yes,(Delayed antibiotics);
- No (no antibiotics).
- Decisional conflict [ Time Frame: After index consultation ]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.
- Adherence to the decision that was made [ Time Frame: 2 weeks after the index consultation ]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.
- Decisional regret [ Time Frame: 2 weeks after the index consultation ]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.
- Quality of life (QOL) [ Time Frame: Baseline and 2 weeks after the index consultation ]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.
- Intention to engage in SDM in future consultations dealing with antibiotic use for ARI [ Time Frame: Baseline and 2 weeks after the index consultation ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116076
|Centre Hospitalier Université Laval - Hôpital St-François d'Assise|