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

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00791362
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
1,685
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2
48
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: National programme for accreditation and improvement of GP
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1685 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Effects and Costs of a National Continuous Improvement Programme on Cardiovascular Diseases in Primary Care
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. 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. [dec 2008-feb 2011]

Secondary Outcome Measures

  1. 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. [dec 2008-feb 2011]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with established cardiovascular diseases (myocard infarct, angina pectoris, cerebrovascular accident, Transient Ischaemic Attack, peripheral vascular disease, aneurysma aortae)
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 23 Locations Nijmegen Netherlands

Sponsors and Collaborators

  • Radboud University Medical Center
  • ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Michel Wensing, Dr, IQ Scientific Institute for Quality of HealthCare - UMC St Radboud

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT00791362
Other Study ID Numbers:
  • PAHVZ
  • 170883001
First Posted:
Nov 14, 2008
Last Update Posted:
Jul 9, 2013
Last Verified:
May 1, 2012
Keywords provided by Radboud University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2013