- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
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Nijmegen, Holandia
- 23 Locations
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Patients with established cardiovascular diseases (myocard infarct, angina pectoris, cerebrovascular accident, Transient Ischaemic Attack, peripheral vascular disease, aneurysma aortae)
Exclusion Criteria:
-
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Inny: 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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Inny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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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.
Ramy czasowe: dec 2008-feb 2011
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dec 2008-feb 2011
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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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.
Ramy czasowe: dec 2008-feb 2011
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dec 2008-feb 2011
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Michel Wensing, Dr, IQ Scientific Institute for Quality of HealthCare - UMC St Radboud
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PAHVZ
- 170883001
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