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Evaluation Research of a National Accreditation and Improvement Programme for General Practice

This study is currently recruiting participants.
Verified May 2012 by Radboud University
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00791362
First received: November 13, 2008
Last updated: July 23, 2012
Last verified: May 2012
History of Changes

November 13, 2008
July 23, 2012
December 2008
August 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: dec 2008-feb 2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00791362 on ClinicalTrials.gov Archive Site
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. [ Time Frame: dec 2008-feb 2011 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Cardiovascular Disease
Other: National programme for accreditation and improvement of GP
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.
  • improvement programme CVD
    Intervention: Other: National programme for accreditation and improvement of GP
  • improvement programme other conditions
    Intervention: Other: National programme for accreditation and improvement of GP
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2800
October 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with established cardiovascular diseases (myocard infarct, angina pectoris, cerebrovascular accident, Transient Ischaemic Attack, peripheral vascular disease, aneurysma aortae)

Exclusion Criteria:

-
Both
Not Provided
No
Contact: Elvira Nouwens, MSc 003124-3619048 e.nouwens@iq.umcn.nl
Netherlands
 
NCT00791362
PAHVZ, 170883001
No
Radboud University
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Michel Wensing, Dr IQ Scientific Institute for Quality of HealthCare - UMC St Radboud
Radboud University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP