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

24 mai 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

1900

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Pas plus vieux que 120 ans (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Autres noms:
  • Intervention précoce
Comparateur 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.
Autres noms:
  • Late Intervention

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in number of prescribed drugs in patients above 65 years in the observation periods.
Délai: 6 months periods
Data regarding Prescription medication is retrieved from Nationwide Medication Database (MD)
6 months periods

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2014

Achèvement primaire (Anticipé)

1 juillet 2017

Achèvement de l'étude (Anticipé)

1 décembre 2020

Dates d'inscription aux études

Première soumission

29 mars 2016

Première soumission répondant aux critères de contrôle qualité

3 mai 2016

Première publication (Estimation)

4 mai 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

26 mai 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mai 2016

Dernière vérification

1 mai 2016

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • NAGEP_RCT01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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