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

24 maggio 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

1900

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 120 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altri nomi:
  • Intervento precoce
Comparatore placebo: 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.
Altri nomi:
  • Late Intervention

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in number of prescribed drugs in patients above 65 years in the observation periods.
Lasso di tempo: 6 months periods
Data regarding Prescription medication is retrieved from Nationwide Medication Database (MD)
6 months periods

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2014

Completamento primario (Anticipato)

1 luglio 2017

Completamento dello studio (Anticipato)

1 dicembre 2020

Date di iscrizione allo studio

Primo inviato

29 marzo 2016

Primo inviato che soddisfa i criteri di controllo qualità

3 maggio 2016

Primo Inserito (Stima)

4 maggio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 maggio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • NAGEP_RCT01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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