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

Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases, Obstructive
• Intervention / Treatment: Behavioral: care at initiative of the patient (usual GP care); Behavioral: regular practice nurse review (monitoring controls); Behavioral: an integrated self-management education program

Detailed 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?

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Radboud University, Department of General Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: usual care; usual care, i.e. COPD care at patient's own initiative, mostly for medical help during exacerbations	Behavioral: care at initiative of the patient (usual GP care); care at initiative of the patient (usual GP care)
Experimental: monitoring controls; regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines	Behavioral: regular practice nurse review (monitoring controls); protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Experimental: self-management; disease specific self-management program 'Living Well with COPD'	Behavioral: an integrated self-management education program; disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease-specific health-related quality of life (HRQoL)	two years

Secondary Outcome Measures

Outcome Measure	Time Frame
the number of exacerbations	two years
generic quality of life	two years
decline post- and pre-bronchodilator (BD) lung function indices	two years
level of respiratory symptoms	two years
satisfaction with the health care received	two years
compliance with (non-) pharmaceutical treatment	two years
direct and indirect medical costs	two years
COPD related self-efficacy	two years
COPD coping styles	two years

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: McGill University; Erasmus Medical Center; ZonMw: The Netherlands Organisation for Health Research and Development; PICASSO: Partners in Care Solutions for COPD
• Investigators: Study Chair: Chris van Weel, FRCP, Department of General Practice, Radboud University, Nijmegen, The Netherlands; Study Director: Tjard Schermer, PhD, Department of General Practice, Radboud University, Nijmegen, The Netherlands; Principal Investigator: Erik Bischoff, MD, Department of General Practice, Radboud University, Nijmegen, The Netherlands

Publications and helpful links

General Publications

• Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
• Monninkhof E, van der Valk P, van der Palen J, van Herwaarden C, Partridge MR, Zielhuis G. Self-management education for patients with chronic obstructive pulmonary disease: a systematic review. Thorax. 2003 May;58(5):394-8. doi: 10.1136/thorax.58.5.394.
• Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD. Patient Educ Couns. 2004 Mar;52(3):271-7. doi: 10.1016/S0738-3991(03)00102-2.
• Bischoff EW, Akkermans R, Bourbeau J, van Weel C, Vercoulen JH, Schermer TR. Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial. BMJ. 2012 Nov 28;345:e7642. doi: 10.1136/bmj.e7642.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 9, 2005
• First Submitted That Met QC Criteria: August 9, 2005
• First Posted (Estimate): August 10, 2005

Study Record Updates

• Last Update Posted (Estimate): November 22, 2011
• Last Update Submitted That Met QC Criteria: November 21, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: randomized controlled trial; self-management; cost-effectiveness; practice nurse; chronic obstructive pulmonary disease (COPD)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: MONC95582; ZonMw grant: 945.04.230 (Other Grant/Funding Number: ZonMw); Picasso grant: 005.2004 (Other Grant/Funding Number: Picasso); CMO: 2004/249 (Other Identifier: Medical Ethics Committee)