Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice

Radboud University Medical Center

Status: Completed

Conditions: Lung Diseases, Obstructive

Treatments: Behavioral: care at initiative of the patient (usual GP care); Behavioral: regular practice nurse review (monitoring controls); Behavioral: an integrated self-management education program

Study type: Interventional

Funder types: Other

Identifiers

NCT00128765

CMO: 2004/249 (Other Identifier)

Picasso grant: 005.2004 (Other Grant/Funding Number)

ZonMw grant: 945.04.230 (Other Grant/Funding Number)

MONC95582

Details and patient eligibility

About

In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

• usual general practitioner (GP) care (at patient's initiative);
• regular practice nurse review; and
• integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.

Full description

Considering the ageing of the Dutch population and the current and increasing shortage of general practitioners (GPs), the capacity of primary healthcare is a major and growing concern. Delegation of care normally provided by GPs with care provided by trained practice nurses is now rapidly emerging for patients with chronic respiratory disease, i.e. asthma and chronic obstructive pulmonary disease (COPD). However, most general practices still provide care at initiative of the patient self, because of the lack in scientific evidence and the costs of implementing a regular care structure. Self-care by patients may be an alternative to alleviate the growing load on primary health care.

The following two main research questions are addressed in this study.

• Does an integrated self-management education intervention for patients with COPD in general practice contribute to attaining long-term treatment targets, compared to regular monitoring by a practice nurse and usual GP care?
• What is the cost-effectiveness of an integrated self-management education intervention for patients with COPD, compared to regular monitoring by a practice nurse and usual GP care?

Enrollment: 165 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Registered in one of the general practices participating in the study
• Diagnosis of COPD, with Global Initiative for Chronic Obstructive Lung Diseases (GOLD) stage I, II or III
• Age ≥35 years
• Willing to provide written informed consent

Exclusion criteria

• Very poor prognosis with regard to respiratory condition (GOLD stage IV)
• Severe co-morbid conditions with a reduced life expectancy
• Unable to communicate in the Dutch language
• Objections to one or more of the disease management modes in the study

Trial design

165 participants in 3 patient groups

usual care

Active Comparator group

Description:

usual care, i.e. COPD care at patient's own initiative, mostly for medical help during exacerbations

Treatment:

Behavioral: care at initiative of the patient (usual GP care)

monitoring controls

Experimental group

Description:

regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines

Treatment:

Behavioral: regular practice nurse review (monitoring controls)

self-management

Experimental group

Description:

disease specific self-management program 'Living Well with COPD'

Treatment:

Behavioral: an integrated self-management education program