- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Nijmegen, Olanda
- 23 Locations
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients with established cardiovascular diseases (myocard infarct, angina pectoris, cerebrovascular accident, Transient Ischaemic Attack, peripheral vascular disease, aneurysma aortae)
Exclusion Criteria:
-
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: improvement programme CVD
|
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.
|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
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.
Lasso di tempo: dec 2008-feb 2011
|
dec 2008-feb 2011
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
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.
Lasso di tempo: dec 2008-feb 2011
|
dec 2008-feb 2011
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Michel Wensing, Dr, IQ Scientific Institute for Quality of HealthCare - UMC St Radboud
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PAHVZ
- 170883001
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .