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

Not Applicable

Completed

• Conditions: Implementation of a Chronic Disease Management Programme; COPD
• Interventions: Other: Active implementation of a guideline for chronic disease

• Registration Number: NCT01228708
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-10
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Study Completion: 2011-11
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-27
• Last Update Posted: 2012-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3021

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.

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Exclusion Criteria

• People who do not fit the above inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Active implementation of a guideline for chronic disease	Patients from half the GP practices in Ringkoebing-Skjern municipality that participates in an active implementation of a guideline for COPD

Primary Outcome Measures

Name	Time	Method
Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources.	14 months

Secondary Outcome Measures

Name	Time	Method
Health professionals	14 months	How health professionals perceive the implementation and how it influences their conception, interactions and culture.