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

NCT00791362 | Completed

• 2 other identifiers: PAHVZ170883001
• Study Type: interventional
• Target: 1,685
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

accreditation; cardiovascular disease; primary care

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

improvement programme CVD

OTHER

Other: National programme for accreditation and improvement of GP

improvement programme other conditions

OTHER

Other: National programme for accreditation and improvement of GP

Interventions

National programme for accreditation and improvement of GP OTHER

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; improvement programme other conditions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

23 Locations

Nijmegen, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 25463149 DERIVED

• 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.

  PMID: 23035760 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Accreditation

Intervention Hierarchy (Ancestors)

Credentialing; Social Control, Formal; Health Care Economics and Organizations; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Michel Wensing, Dr

  IQ Scientific Institute for Quality of HealthCare - UMC St Radboud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 9, 2013

Record last verified: 2012-05

Locations

NL (1)