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Quality ControlACIAPNCT02762240

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

A study testing DHQP 2016 and DHQP 2018 in people with Quality Control, run by University of Southern Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 120 years
Conditions the study is for
Quality Control
What is being tested?
DHQP 2016 and DHQP 2018
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,900 participants
Where
No sites listed yet
Study dates
Jun 2014to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

About this study

Official title: 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.

Read the 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.

Conditions
Quality Control
Being tested
DHQP 2016, DHQP 2018
Keywords
Accreditation, Certification, General Practice, Family Medicine, Randomized Controlled Trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DHQP 2016Other

    Also called Early Intervention

    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.

  • DHQP 2018Other

    Also called Late Intervention

    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.

Study groups in NCT02762240
Study groupRoleWhat they receive
DHQP 2016Active comparatorThis group consists of general practices allocated to undergo accreditation scheme in 2016.
Receives: Other: DHQP 2016
DHQP 2018Placebo comparatorThis group consists of general practices allocated to undergo accreditation scheme in 2018.
Receives: Other: DHQP 2018

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in number of prescribed drugs in patients above 65 years in the observation periods.

    Data regarding Prescription medication is retrieved from Nationwide Medication Database (MD)

    Measured: 6 months periods

Secondary outcomes (9)
  1. • Changes in the proportion of polypharmacy patients above 65 years (>5 prescribed drugs) between periods.

    More than 5 prescribed drugs based on nationwide Medication Database (MD)

    Measured: 6 months periods

  2. • Changes in Daily Drug Dose of NSAID without Proton-pump inhibitor in period between periods.

    Based on nationwide Medication Database (MD)

    Measured: 6 months periods

  3. • Changes in Daily Drug Dose of sleeping medicine between periods.

    Based on nationwide Medication Database (MD)

    Measured: 6 month periods

  4. Changes in the proportion of elderly above 75 receiving a preventive home visit between periods.

    The regional practice remuneration system (RPRS)

    Measured: 6 month periods

  5. Changes in the number of annual controls for chronic diseases between periods.

    The regional practice remuneration system (RPRS)

    Measured: 6 month periods

  6. Changes in the number of spirometry between periods

    The regional practice remuneration system (RPRS)

    Measured: 6 month periods

  7. Changes in proportion of practices with a reported adverse event between periods.

    Danish Patient Security Database (DPSD)

    Measured: 6 month periods

  8. Changes in the proportion of practices with a patient satisfaction survey between periods.

    Danish Patients Evaluation Practice database

    Measured: 6 month period

  9. Changes in mortality rates between periods.

    Statistics Denmark

    Measured: 2 month periods from index date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2016 (estimated)
  2. Study startJun 2014
  3. Primary completionJul 2017 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02762240
Sponsor's protocol ID
NAGEP_RCT01
Acronym
ACIAP
Status last verified
May 2016
First submitted
29 Mar 2016
Last updated
26 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Kirstine Andersen M, Pedersen LB, Waldorff FB. Retirement, job satisfaction and attitudes towards mandatory accreditation: a Danish survey study in general practice. BMJ Open. 2018 Aug 13;8(8):e020419. doi: 10.1136/bmjopen-2017-020419.

    PubMed 30104311
  • Andersen MK, Pedersen LB, Siersma V, Bro F, Reventlow S, Sondergaard J, Kousgaard MB, Waldorff FB. Accreditation in general practice in Denmark: study protocol for a cluster-randomized controlled trial. Trials. 2017 Feb 13;18(1):69. doi: 10.1186/s13063-017-1818-6.

    PubMed 28193288

Questions about this trial

What is this clinical trial studying?

A study testing DHQP 2016 and DHQP 2018 in people with Quality Control, run by University of Southern Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in number of prescribed drugs in patients above 65 years in the observation periods. (time frame: 6 months periods). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02762240, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.

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