Clinical trial NCT00128765: Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases, Obstructive
Keywords: chronic obstructive pulmonary disease (COPD)
self-management
practice nurse
cost-effectiveness
randomized controlled trial
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: PICASSO: Partners in Care Solutions for COPD
name: Erasmus Medical Center
name: McGill University
First posted: 2005-08-10
Enrollment: 165
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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?

Eligibility criteria: 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

Primary outcomes:
measure: disease-specific health-related quality of life (HRQoL)
timeFrame: two years
Secondary outcomes:
measure: the number of exacerbations
timeFrame: two years
measure: generic quality of life
timeFrame: two years
measure: decline post- and pre-bronchodilator (BD) lung function indices
timeFrame: two years
measure: level of respiratory symptoms
timeFrame: two years
measure: satisfaction with the health care received
timeFrame: two years
measure: compliance with (non-) pharmaceutical treatment
timeFrame: two years
measure: direct and indirect medical costs
timeFrame: two years
measure: COPD related self-efficacy
timeFrame: two years
measure: COPD coping styles
timeFrame: two years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University, Department of General Medicine
Study officials:
affiliation: Department of General Practice, Radboud University, Nijmegen, The Netherlands
name: Chris van Weel, FRCP
role: STUDY_CHAIR
affiliation: Department of General Practice, Radboud University, Nijmegen, The Netherlands
name: Tjard Schermer, PhD
role: STUDY_DIRECTOR
affiliation: Department of General Practice, Radboud University, Nijmegen, The Netherlands
name: Erik Bischoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.