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.
調査の概要
研究の種類
介入
入学 (実際)
712
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Quebec、カナダ
- Centre Hospitalier Université Laval - Hôpital St-François d'Assise
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：コントロール
いつものお手入れ
|
|
|
実験的：DECISION+ Program
Exposure to the Decision+ Program
|
DECISION+ is a multifaceted intervention program that includes: On site course and Internet-based courses (2x120 min), reminders of expected behaviours and feedback.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of patients reporting a decision for "immediate antibiotics."
時間枠：After index consultation
|
After index consultation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decision to use antibiotics
時間枠：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:
|
After index consultation
|
|
Decisional conflict
時間枠：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.
|
After index consultation
|
|
Adherence to the decision that was made
時間枠：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.
|
2 weeks after the index consultation
|
|
Decisional regret
時間枠：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.
|
2 weeks after the index consultation
|
|
Quality of life (QOL)
時間枠：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.
|
Baseline and 2 weeks after the index consultation
|
|
Intention to engage in SDM in future consultations dealing with antibiotic use for ARI
時間枠：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.
|
Baseline and 2 weeks after the index consultation
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年5月1日
一次修了 (実際)
2011年4月1日
研究の完了 (実際)
2011年4月1日
試験登録日
最初に提出
2010年5月3日
QC基準を満たした最初の提出物
2010年5月3日
最初の投稿 (見積もり)
2010年5月4日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年2月1日
QC基準を満たした最後の更新が送信されました
2013年1月30日
最終確認日
2013年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。