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| Sponsors and Collaborators: |
Radboud University ZonMw: The Netherlands Organisation for Health Research and Development |
|---|---|
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00791362 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Disease |
Other: National programme for accreditation and improvement of GP |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Open Label, Parallel Assignment |
| Official Title: | Effects and Costs of a National Continuous Improvement Programme on Cardiovascular Diseases in Primary Care |
| Estimated Enrollment: | 2800 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| improvement programme CVD |
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 other conditions |
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.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
-
Contacts and Locations| Contact: Elvira Nouwens, MSc | 003124-3619048 | e.nouwens@iq.umcn.nl |
| Principal Investigator: | Michel Wensing, Dr | IQ Scientific Institute for Quality of HealthCare - UMC St Radboud |
More Information
| Study ID Numbers: | PAHVZ, 170883001 |
| Study First Received: | November 13, 2008 |
| Last Updated: | November 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00791362 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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accreditation cardiovascular disease primary care |
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Cardiovascular Diseases |
