Evaluation of the effect of the diagnostic and therapeutic advices given by an Asthma/chronic obstructive pulmonary disease (COPD) service on the referring general practitioners and their patients

ISRCTN	ISRCTN45174826
DOI	https://doi.org/10.1186/ISRCTN45174826
Protocol serial number	Internal budget number 30.95.01.04.b
Sponsor	Care and Public Health Research Institute (CAPHRI) (The Netherlands)
Funder	Partners in Care Solutions (PICASSO) (The Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 10/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marion Drietelaar
Scientific

Onderzoeksinstituut Caphri
Universiteit van Maastricht
Postbus 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 388 2272
Email	Marion.Drietelaar@HAG.unimaas.nl

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Asthma, chronic obstructive pulmonary disease (COPD)
Intervention	The intervention in the trial was the diagnostic and therapeutic advice offered to the general practitioners by the Asthma/COPD-service in Eindhoven. These advices are a new but already introduced facility for general practitioners and their patients. This facility is in the process of implementation. General practitioners in the research project who, after randomisation, are eligible to first use the facility are considered to be the intervention group (N=17). General practitioners who dont get the full support of the Asthma/COPD-service yet (N=17) are considered to be the control group. Each general practice participates in the research project for two years. In this period the patients of the intervention group receive two yearly follow-up consultations at the Asthma/COPD service, on request of their general practitioner. Medical history and spirometry is performed. A lung specialist assesses by protocol the written results of these measurements and sends a structured report to the general practitioner. This report includes a diagnosis or an advice for further diagnostic examinations, and advices for treatment. In the control group the general practitioners can have spirometry performed for their patients in the way they are used to. However, they dont get the full report of the Asthma/COPD-service, only the description of the lung function.
Intervention type	Other
Primary outcome measure(s)	1. Do general practitioners assess better diagnoses, according tot the NHG-standards, in Asthma/COPD-patients: do more patients have a correct diagnosis, do less patients have a wrong or incomplete diagnosis or no diagnosis at all? 2. Do general practitioners give their patients a better treatment, according to the NHG-standards: do more patients get the right medication, do less patients get wrong or unnecessary medication. Do patients receive more information about their disease and about self management? 3. Do patients have a better compliance, do they better follow the advices about stop smoking, exercise, do they have fewer complaints and a better quality of life?
Key secondary outcome measure(s)	1. Validity and reliability of the assessment and the reports of the Asthma/COPD-service 2. Epidemiological data about the prevalence of Asthma/COPD in general practices, the (incorrect) use of medication of in general practice 3. Costs of a support as given by the Asthma/COPD-service, related to the diagnostic and therapeutic gain in patient care
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	1000
Key inclusion criteria	All general practices in and around the city of Eindhoven could be included as long as they used the facilities of the Diagnostic Centre, which the Asthma/COPD-service is a part of. Although they should not have any experience with the support of the Asthma/COPD-service. They were also excluded in case they had employed a "praktijkondersteuner" (specialised nurse or assistant) for the Asthma/COPD disease management. In the intervention as well as in the control practices, all patients 12 years and older that have airway complaints could participate as long as they were not treated by a lung specialist.
Key exclusion criteria	See inclusion criteria.
Date of first enrolment	01/01/2003
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Onderzoeksinstituut Caphri

Maastricht
6200 MD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan