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The Effectiveness of a Nationwide Mandatory Accreditation in General Practice in Denmark

The Effectiveness of a Nationwide Mandatory Accreditation in General Practice in Denmark: A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02762240
Acronym
ACIAP
Enrollment
1900
Registered
2016-05-04
Start date
2014-06-30
Completion date
2020-12-31
Last updated
2016-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality Control

Keywords

Accreditation, Certification, General Practice, Family Medicine, Randomized Controlled Trial

Brief summary

Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence of the effectiveness of accreditation. The overall aim of this study is to evaluate the effectiveness of a mandatory accreditation in general practice.

Detailed description

Accreditation has become a widespread tool for quality control and development, and large resources are spent upon development and implementation of accreditation systems in health care systems all over the world. Accreditation of healthcare systems has met some critique. Evidence for positive effects of accreditation has been called for, and health care professionals have expressed concerns about extra hours imposed by accreditation. However, only few studies have evaluated the effects of accreditation on central items, such as clinical outcomes and patient satisfaction. In general, the results from the different types of studies are ambiguous and there are only few well-accomplished effect studies. Hence, only two effect studies met the methodological inclusion criteria of a recent Cochrane review. None of these studies treated general practice. A review regarding status of accreditation in primary care concluded that there is a dearth of research on the nature and uptake of accreditation in this sector along with how accreditation affects outcomes of care, and whether it is an effective method to improve quality, perceptions of care, healthcare utilisation and costs. Two studies provided evidence to suggest that accreditation status was associated with infection control procedures, risk management programmes and quality improvement activities and after-treatment plans. However, in the latter case, post hoc analysis revealed that accreditation was associated with units' organizational contexts and referral sources as well as the nature of the competitive environment. The authors concluded that accreditation and licensing might reveal as much about a care units' institutional environments as about the quality of treatment provided. Accreditation is a relatively new instrument in general practice and its effects on clinical outcomes, patient satisfaction, general practitioners' (GPs') job satisfaction and organisational aspects must be evaluated in order to assess the overall utility for patients and society. Although accreditation has been implemented in general practice in nine European countries, and in Australia and New Zealand, research elucidating the effects of accreditation in general practice system, is strongly needed. In spite of this lack of evidence for effect of accreditation on clinical and patient related objectives, it has been decided to implement accreditation as a mandatory instrument in Danish general practice. The Danish Healthcare Quality Programme (DHQP) is based on general principles for accreditation. The model contains a set of accreditation standards as well as an accreditation process. Accreditation has for a longer time period been mandatory in the secondary healthcare system in Denmark, and it has now been decided to include general practice as well. Hence, the DHQP has been adjusted to general practice. DHQP for general practice consists of 16 standards with associated indicators within the following areas: 1. Quality and patient safety, 2. Patient safety critical standards, 3. Good patient continuity of care, 4. Management and organisation. The first practices are accredited in January 2016, and at the end of 2018 all Danish practices should be accredited. An exception is practices with expected termination within 5 years. Since accreditation is a complex intervention, containing several dimensions and active components, it is of great importance to elucidate these processes and mechanisms that become evident with the roll-out and implementation of accreditation and to examine the possible impact, accreditation may have on health care within primary care.

Interventions

OTHERDHQP 2016

DHQP for general practice consists of 16 standards with associated indicators within the following areas: 1. Quality and patient safety, 2. Patient safety critical standards, 3. Good patient continuity of care, 4. Management and organisation.

OTHERDHQP 2018

DHQP for general practice consists of 16 standards with associated indicators within the following areas: 1. Quality and patient safety, 2. Patient safety critical standards, 3. Good patient continuity of care, 4. Management and organisation.

Sponsors

University of Copenhagen
CollaboratorOTHER
University of Aarhus
CollaboratorOTHER
The Danish Institute for Quality and Accreditation in Healthcare
CollaboratorUNKNOWN
University of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No

Inclusion criteria

* General practices working under the Danish Health Insurance at June 2014

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Changes in number of prescribed drugs in patients above 65 years in the observation periods.6 months periodsData regarding Prescription medication is retrieved from Nationwide Medication Database (MD)

Secondary

MeasureTime frameDescription
• Changes in Daily Drug Dose of NSAID without Proton-pump inhibitor in period between periods.6 months periodsBased on nationwide Medication Database (MD)
• Changes in Daily Drug Dose of sleeping medicine between periods.6 month periodsBased on nationwide Medication Database (MD)
Changes in the proportion of elderly above 75 receiving a preventive home visit between periods.6 month periodsThe regional practice remuneration system (RPRS)
Changes in the number of annual controls for chronic diseases between periods.6 month periodsThe regional practice remuneration system (RPRS)
• Changes in the proportion of polypharmacy patients above 65 years (>5 prescribed drugs) between periods.6 months periodsMore than 5 prescribed drugs based on nationwide Medication Database (MD)
Changes in proportion of practices with a reported adverse event between periods.6 month periodsDanish Patient Security Database (DPSD)
Changes in the proportion of practices with a patient satisfaction survey between periods.6 month periodDanish Patients Evaluation Practice database
Changes in mortality rates between periods.2 month periods from index dateStatistics Denmark
Changes in the number of spirometry between periods6 month periodsThe regional practice remuneration system (RPRS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026