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Effects of an Active Implementation of a Guideline for Chronic Obstructive Pulmonary Disease

27 mars 2012 mis à jour par: University of Aarhus

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

3021

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

35 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

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: 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
Aucune intervention: 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
Aucune intervention: External control
Patients with GP practice in neighboring county Ikast-Brande where there have been no information or contact at all from the investigators

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources.
Délai: 14 months
14 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Health professionals
Délai: 14 months
How health professionals perceive the implementation and how it influences their conception, interactions and culture.
14 months

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Chercheur principal: Margrethe IC Smidth, PT MSc, The Research Unit for General Practice Aarhus

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 août 2009

Achèvement primaire (Réel)

1 octobre 2010

Achèvement de l'étude (Réel)

1 novembre 2011

Dates d'inscription aux études

Première soumission

25 octobre 2010

Première soumission répondant aux critères de contrôle qualité

25 octobre 2010

Première publication (Estimation)

26 octobre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

28 mars 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 mars 2012

Dernière vérification

1 mars 2012

Plus d'information

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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