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

24. mai 2016 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

1900

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 120 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: DHQP 2016
This group consists of general practices allocated to undergo accreditation scheme in 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.
Andre navn:
  • Tidlig intervensjon
Placebo komparator: DHQP 2018
This group consists of general practices allocated to undergo accreditation scheme in 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.
Andre navn:
  • Late Intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in number of prescribed drugs in patients above 65 years in the observation periods.
Tidsramme: 6 months periods
Data regarding Prescription medication is retrieved from Nationwide Medication Database (MD)
6 months periods

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
• Changes in the proportion of polypharmacy patients above 65 years (>5 prescribed drugs) between periods.
Tidsramme: 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.
Tidsramme: 6 months periods
Based on nationwide Medication Database (MD)
6 months periods
• Changes in Daily Drug Dose of sleeping medicine between periods.
Tidsramme: 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.
Tidsramme: 6 month periods
The regional practice remuneration system (RPRS)
6 month periods
Changes in the number of annual controls for chronic diseases between periods.
Tidsramme: 6 month periods
The regional practice remuneration system (RPRS)
6 month periods
Changes in the number of spirometry between periods
Tidsramme: 6 month periods
The regional practice remuneration system (RPRS)
6 month periods
Changes in proportion of practices with a reported adverse event between periods.
Tidsramme: 6 month periods
Danish Patient Security Database (DPSD)
6 month periods
Changes in the proportion of practices with a patient satisfaction survey between periods.
Tidsramme: 6 month period
Danish Patients Evaluation Practice database
6 month period
Changes in mortality rates between periods.
Tidsramme: 2 month periods from index date
Statistics Denmark
2 month periods from index date

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2014

Primær fullføring (Forventet)

1. juli 2017

Studiet fullført (Forventet)

1. desember 2020

Datoer for studieregistrering

Først innsendt

29. mars 2016

Først innsendt som oppfylte QC-kriteriene

3. mai 2016

Først lagt ut (Anslag)

4. mai 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. mai 2016

Sist bekreftet

1. mai 2016

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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