The Effectiveness of a Nationwide Mandatory Accreditation in General Practice in Denmark (ACIAP)

May 24, 2016 updated by: Frans Boch Waldorff, University of Southern Denmark

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1900

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DHQP 2016
This group consists of general practices allocated to undergo accreditation scheme in 2016.
Other: DHQP 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.
Other Names:
  • Early Intervention
Placebo Comparator: DHQP 2018
This group consists of general practices allocated to undergo accreditation scheme in 2018.
Other: DHQP 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.
Other Names:
  • Late Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in number of prescribed drugs in patients above 65 years in the observation periods.
Time Frame: 6 months periods
Data regarding Prescription medication is retrieved from Nationwide Medication Database (MD)
6 months periods

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Changes in the proportion of polypharmacy patients above 65 years (>5 prescribed drugs) between periods.
Time Frame: 6 months periods
More than 5 prescribed drugs based on nationwide Medication Database (MD)
6 months periods
• Changes in Daily Drug Dose of NSAID without Proton-pump inhibitor in period between periods.
Time Frame: 6 months periods
Based on nationwide Medication Database (MD)
6 months periods
• Changes in Daily Drug Dose of sleeping medicine between periods.
Time Frame: 6 month periods
Based on nationwide Medication Database (MD)
6 month periods
Changes in the proportion of elderly above 75 receiving a preventive home visit between periods.
Time Frame: 6 month periods
The regional practice remuneration system (RPRS)
6 month periods
Changes in the number of annual controls for chronic diseases between periods.
Time Frame: 6 month periods
The regional practice remuneration system (RPRS)
6 month periods
Changes in the number of spirometry between periods
Time Frame: 6 month periods
The regional practice remuneration system (RPRS)
6 month periods
Changes in proportion of practices with a reported adverse event between periods.
Time Frame: 6 month periods
Danish Patient Security Database (DPSD)
6 month periods
Changes in the proportion of practices with a patient satisfaction survey between periods.
Time Frame: 6 month period
Danish Patients Evaluation Practice database
6 month period
Changes in mortality rates between periods.
Time Frame: 2 month periods from index date
Statistics Denmark
2 month periods from index date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

University of Copenhagen
University of Aarhus
The Danish Institute for Quality and Accreditation in Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NAGEP_RCT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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