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.
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 group | Role | What they receive |
|---|---|---|
| DHQP 2016 | Active comparator | This group consists of general practices allocated to undergo accreditation scheme in 2016. Receives: Other: DHQP 2016 |
| DHQP 2018 | Placebo comparator | This 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.
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)
• 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
• 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
• Changes in Daily Drug Dose of sleeping medicine between periods.
Based on nationwide Medication Database (MD)
Measured: 6 month periods
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
Changes in the number of annual controls for chronic diseases between periods.
The regional practice remuneration system (RPRS)
Measured: 6 month periods
Changes in the number of spirometry between periods
The regional practice remuneration system (RPRS)
Measured: 6 month periods
Changes in proportion of practices with a reported adverse event between periods.
Danish Patient Security Database (DPSD)
Measured: 6 month periods
Changes in the proportion of practices with a patient satisfaction survey between periods.
Danish Patients Evaluation Practice database
Measured: 6 month period
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.
- First posted4 May 2016 (estimated)
- Study startJun 2014
- Primary completionJul 2017 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality ControlStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Aarhus, The Danish Institute for Quality and Accreditation in Healthcare
- Responsible party
- Principal investigator, Frans Boch Waldorff, University of Southern Denmark
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 30104311Andersen 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
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Nationwide Mandatory Accreditation in General Practice in Denmark: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02762240
- Acronym / sponsor ID
- ACIAP / NAGEP_RCT01
- Conditions
- Quality Control
- Keywords
- Accreditation, Certification, General Practice, Family Medicine, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Aarhus, The Danish Institute for Quality and Accreditation in Healthcare
- Study start
- Jun 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHQP 2016 | Active comparator | Other: DHQP 2016This group consists of general practices allocated to undergo accreditation scheme in 2016. |
| DHQP 2018 | Placebo comparator | Other: DHQP 2018This group consists of general practices allocated to undergo accreditation scheme in 2018. |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- General practices working under the Danish Health Insurance at June 2014
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHQP 2016Also: Early InterventionDHQP 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 | DHQP 2016 |
| DHQP 2018Also: Late InterventionDHQP 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 | DHQP 2018 |
Primary outcome
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)
9 secondary outcomes
• Changes in the proportion of polypharmacy patients above 65 years (>5 prescribed drugs) between periods.
Time frame: 6 months periods
• Changes in Daily Drug Dose of NSAID without Proton-pump inhibitor in period between periods.
Time frame: 6 months periods
• Changes in Daily Drug Dose of sleeping medicine between periods.
Time frame: 6 month periods
Changes in the proportion of elderly above 75 receiving a preventive home visit between periods.
Time frame: 6 month periods
Changes in the number of annual controls for chronic diseases between periods.
Time frame: 6 month periods
Changes in the number of spirometry between periods
Time frame: 6 month periods
Changes in proportion of practices with a reported adverse event between periods.
Time frame: 6 month periods
Changes in the proportion of practices with a patient satisfaction survey between periods.
Time frame: 6 month period
Changes in mortality rates between periods.
Time frame: 2 month periods from index date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Derived from this study: PubMed 30104311Kirstine 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.
- Derived from this study: PubMed 28193288Andersen 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.
- Webpage of the Research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.