- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01228708
Effects of an Active Implementation of a Guideline for Chronic Obstructive Pulmonary Disease
Effects of an Active Implementation of a Chronic Disease Management Programme for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Aims:
To design a proactive implementation strategy for a chronic-disease-management-programme.
To describe effects of the active implementation of a programme for COPD-patients measured on patient-related goals and use of health resources.
To describe stakeholders' evaluation of the implementation.
Materials and method:
An intervention study with 3000 COPD-patients cluster-randomized after a bloc-randomization of their GP-practice. 18 GP-practices in Ringkøbing-Skjern-Municipality are randomized to receive an active implementation or to an "as usual" group. A neighboring municipality acts as "sleeping" control. With data from registers and a questionnaire-survey the effect on COPD-patients self reported-health, evaluation of health system and changes in distribution of health resources is analyzed. How health professionals perceive the implementation and how it influences their conception, interactions and culture is illustrated by interviews with stakeholders.
We expect to see improved health related quality of life, enhanced evaluation of the health system and a more appropriate distribution of health resources in the intervention group.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
BACKGROUND:
Health systems will manage more and more people with chronic diseases as life-expectancy increases and treatment options improve. As the need for resources increases, it will be vital that a targeted strategy for health care to this growing group is developed so all are offered a professional and efficient treatment and that resources are used equitable. A proactive strategy will secure that not only acute needs of patients, but the need of the whole population is served.
AIM:
To describe the process of implementation and the effects of Central Denmark Region's chronic disease management programme for COPD-patients.
METHOD:
This is an intervention study, where approximately 3000 COPD-patients will be cluster-randomized after a bloc-randomization of their GP-practice. 15 GP-practices in Ringkøbing-Skjern Municipality will be randomized to receive the focused implementation or to an "as usual" group.
Approximately 4000 COPD patients from a neighboring municipality with a similar profile will be a control group without any active implementation in any GP-practice and any contamination between GP-practices will therefore be eliminated.
THE INTERVENTION:
A proactive implementation strategy for the chronic disease management programme will be designed based on the literature and methods which have proven effective in implementing new ways of working when different stakeholders and cultures are involved.
Core intervention elements: GP-practice visits and education with focus on registration of smoking status and offering of smoking cessation, stratification of COPD patients according to health level or disease status, written referral from GP to community initiatives and written feedback to GP, discharge notice to GP from hospital, home visit by GP or practice nurse together with community nurse to plan care with newly discharged frail patients,
With data from registers and a questionnaire-survey the effect on COPD-patients self reported health, evaluation of the health system and changes in the distribution of health resources will be analyzed. How the health professionals in hospital, community-care and in GP-practices perceive the implementation and how it influences their conception, interactions and culture will be illustrated in an interview-survey of stakeholders.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- People who live in either Ringkoebing-Skjern or Ikast-Brande municipalities and have a GP in the municipality and have been in hospital during the last 5 years with a lung related diagnosis or has redeemed a prescription for medication for lung related problems twice during the last year or has had at least two spirometries done during the last year.
Exclusion Criteria:
- People who do not fit the above inclusion criteria
Plano de estudo
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: Intervention
Patients from half the GP practices in Ringkoebing-Skjern municipality that participates in an active implementation of a guideline for COPD
|
Smoking cessation courses Remuneration to GPs for the planned follow-up and joint home visits Action card and sputum colour advice Webpage on "How to live with COPD" and the support the health system can provide Database with patients with COPD Feed-back from health centre to GPs, when patients have finished courses Fax from hospital to GPs, when patients with COPD is discharged Routines to recall patients for follow-ups Team audit, evaluate and adjust the strategies every 3rd month Joint home visit with GP and community nurse when a patient with COPD is discharged to plan future care Practice staff do part of follow-ups and monitoring Practice supervision with consultant in lung diseases Podcast with advice from specialists Guideline for COPD
|
|
Sem intervenção: Control group
Patients from the half of the GP practice in Ringkoebing-Skjern that do not participate in the active implementation of a guideline for COPD.
The GPs are however in postgraduate training groups with intervention groups GPs
|
|
|
Sem intervenção: External control
Patients with GP practice in neighboring county Ikast-Brande where there have been no information or contact at all from the investigators
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources.
Prazo: 14 months
|
14 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Health professionals
Prazo: 14 months
|
How health professionals perceive the implementation and how it influences their conception, interactions and culture.
|
14 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Margrethe IC Smidth, PT MSc, The Research Unit for General Practice Aarhus
Publicações e links úteis
Publicações Gerais
- Smidth M, Christensen MB, Fenger-Gron M, Olesen F, Vedsted P. The effect of an active implementation of a disease management programme for chronic obstructive pulmonary disease on healthcare utilization--a cluster-randomised controlled trial. BMC Health Serv Res. 2013 Oct 3;13:385. doi: 10.1186/1472-6963-13-385.
- Smidth M, Olesen F, Fenger-Gron M, Vedsted P. Patient-experienced effect of an active implementation of a disease management programme for COPD - a randomised trial. BMC Fam Pract. 2013 Oct 3;14:147. doi: 10.1186/1471-2296-14-147.
- Smidth M, Christensen MB, Olesen F, Vedsted P. Developing an active implementation model for a chronic disease management program. Int J Integr Care. 2013 Jun 17;13:e020. doi: 10.5334/ijic.994. Print 2013 Apr.
- Smidth M, Sokolowski I, Kaersvang L, Vedsted P. Developing an algorithm to identify people with Chronic Obstructive Pulmonary Disease (COPD) using administrative data. BMC Med Inform Decis Mak. 2012 May 22;12:38. doi: 10.1186/1472-6947-12-38.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Active Implementation-FEAA
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Fraunhofer-Institute of Toxicology and Experimental...Institute for Pharmacology and Toxicology, RWTH AachenConcluídoVoluntários Saudáveis | COPD GOLD I a IV | Asma GINA 1 a 4Alemanha