DECISION+, a Training Program to Improve Optimal Drug Prescription (Decision+)
2013년 1월 30일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
712
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Quebec, 캐나다
- Centre Hospitalier Université Laval - Hôpital St-François d'Assise
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 제어
평상시 관리
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Proportion of patients reporting a decision for "immediate antibiotics."
기간: After index consultation
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After index consultation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Decision to use antibiotics
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 5월 1일
기본 완료 (실제)
2011년 4월 1일
연구 완료 (실제)
2011년 4월 1일
연구 등록 날짜
최초 제출
2010년 5월 3일
QC 기준을 충족하는 최초 제출
2010년 5월 3일
처음 게시됨 (추정)
2010년 5월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 2월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 1월 30일
마지막으로 확인됨
2013년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .