- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00791362
Evaluation Research of a National Accreditation and Improvement Programme for General Practice
Effects and Costs of a National Continuous Improvement Programme on Cardiovascular Diseases in Primary Care
Objective: This study aims to determine the effectiveness and efficiency of a national accreditation and improvement programme for general practice, focusing on patients with established cardiovascular diseases.
Design: Cluster randomised trial with a block design. All practices start with the accreditation procedure.Intervention group practices are requested to focus their improvement plans in the first year on cardiovascular disease. Control group practices are requested to focus their improvement plans in the first year on other domains. Measurements at baseline are based on the standard audit in the accreditation procedure. Follow-up measurements are done 12 months after approval of improvement plans.
Participants: Primary care physicians in The Netherlands.
Interventions to be implemented: improvement plans concerning cardiovascular risk management, as described by recently updated national multidisciplinary evidence-based NHG / CBO guidelines, considering patients with established cardiovascular diseases.
Implementation strategy: The national programme for accreditation and improvement of general practice. This procedure consists of a package of activities, including audit, feedback, improvement plans, and follow-up.
Outcome measures: Primary outcomes are percentages of patients with CVD who have acceptable systolic blood pressure and cholesterol levels (quantified according to the indicators in the accreditation)and who use aspirin or alternatives. Secondary measures include clinical and organisational indicators of quality of cardiovascular care, such as percentages of patients with cardiovascular disease whose risk factors were assessed and who received specific medication.
Economic evaluation: Incremental cost effectiveness ratio's are determined of the implementation strategy compared to no implementation. The analysis will take a societal perspective and a time horizon of the observed period as well as a hypothetical 10 years period (using modelling). Uncertainty related to the estimations is examined with sensitivity analyses and bootstrapping. The long term economic evaluation is based on Markov modelling.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nijmegen, 네덜란드
- 23 Locations
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with established cardiovascular diseases (myocard infarct, angina pectoris, cerebrovascular accident, Transient Ischaemic Attack, peripheral vascular disease, aneurysma aortae)
Exclusion Criteria:
-
공부 계획
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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다른: improvement programme CVD
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The national programme for accreditation and improvement of general practice.
This procedure consists of a package of activities, including audit, feedback, improvement plans, and follow-up.
It is partly based on new theories on quality improvement, including the use of market forces and pressure for accountability.
For the purpose of the study, the intervention group will be requested to focus their improvement plans in the first year on cardiovascular diseases.
The control group is requested to focus their improvement plans in the first year on other domains and to provide cardiovascular care as usual.
|
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다른: improvement programme other conditions
|
The national programme for accreditation and improvement of general practice.
This procedure consists of a package of activities, including audit, feedback, improvement plans, and follow-up.
It is partly based on new theories on quality improvement, including the use of market forces and pressure for accountability.
For the purpose of the study, the intervention group will be requested to focus their improvement plans in the first year on cardiovascular diseases.
The control group is requested to focus their improvement plans in the first year on other domains and to provide cardiovascular care as usual.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percentages of patients with CVD who have acceptable systolic blood pressure and cholesterol levels (quantified according to the indicators in the accreditation)and who use aspirin or alternatives.
기간: dec 2008-feb 2011
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dec 2008-feb 2011
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Clinical and organisational indicators of quality of cardiovascular care, such as percentages of patients with cardiovascular disease whose riskfactors were assessed and who received specific medication.
기간: dec 2008-feb 2011
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dec 2008-feb 2011
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michel Wensing, Dr, IQ Scientific Institute for Quality of HealthCare - UMC St Radboud
간행물 및 유용한 링크
일반 간행물
- Nouwens E, van Lieshout J, Bouma M, Braspenning J, Wensing M. Effectiveness of improvement plans in primary care practice accreditation: a clustered randomized trial. PLoS One. 2014 Dec 2;9(12):e114045. doi: 10.1371/journal.pone.0114045. eCollection 2014.
- Nouwens E, Van Lieshout J, Adang E, Bouma M, Braspenning J, Wensing M. Effectiveness and efficiency of a practice accreditation program on cardiovascular risk management in primary care: study protocol of a clustered randomized trial. Implement Sci. 2012 Oct 4;7:94. doi: 10.1186/1748-5908-7-94.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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