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

This study has been completed.
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 8, 2013
Last verified: May 2012
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effects and Costs of a National Continuous Improvement Programme on Cardiovascular Diseases in Primary Care

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1685
Study Start Date: December 2008
Study Completion Date: December 2012
Primary Completion Date: September 2012 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791362

Locations
Netherlands
23 Locations
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
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
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00791362     History of Changes
Other Study ID Numbers: PAHVZ, 170883001
Study First Received: November 13, 2008
Last Updated: July 8, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
accreditation
cardiovascular disease
primary care

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014