DECISION+, a Training Program to Improve Optimal Drug Prescription (Decision+)
2013年1月30日 更新者：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.
研究概览
研究类型
介入性
注册 (实际的)
712
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Quebec、加拿大
- Centre Hospitalier Université Laval - Hôpital St-François d'Assise
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制
日常护理
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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Proportion of patients reporting a decision for "immediate antibiotics."
大体时间：After index consultation
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After index consultation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Decision to use antibiotics
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年5月1日
初级完成 (实际的)
2011年4月1日
研究完成 (实际的)
2011年4月1日
研究注册日期
首次提交
2010年5月3日
首先提交符合 QC 标准的
2010年5月3日
首次发布 (估计)
2010年5月4日
研究记录更新
最后更新发布 (估计)
2013年2月1日
上次提交的符合 QC 标准的更新
2013年1月30日
最后验证
2013年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.