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

24 de maio de 2016 atualizado por: 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.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Antecipado)

1900

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Não mais velho que 120 anos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Outros nomes:
  • Intervenção Precoce
Comparador de 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.
Outros nomes:
  • Late Intervention

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in number of prescribed drugs in patients above 65 years in the observation periods.
Prazo: 6 months periods
Data regarding Prescription medication is retrieved from Nationwide Medication Database (MD)
6 months periods

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de junho de 2014

Conclusão Primária (Antecipado)

1 de julho de 2017

Conclusão do estudo (Antecipado)

1 de dezembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

29 de março de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de maio de 2016

Primeira postagem (Estimativa)

4 de maio de 2016

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

26 de maio de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de maio de 2016

Última verificação

1 de maio de 2016

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • NAGEP_RCT01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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