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
Secondary identifying numbers Internal budget number 30.95.01.04.b
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

Study designMulticentre, randomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAsthma, chronic obstructive pulmonary disease (COPD)
InterventionThe 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 don’t 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 don’t get the full report of the Asthma/COPD-service, only the description of the lung function.
Intervention typeOther
Primary outcome measure1. 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?
Secondary outcome measures1. 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
Overall study start date01/01/2003
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants1000
Key inclusion criteriaAll 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 criteriaSee inclusion criteria.
Date of first enrolment01/01/2003
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Onderzoeksinstituut Caphri
Maastricht
6200 MD
Netherlands

Sponsor information

Care and Public Health Research Institute (CAPHRI) (The Netherlands)
Research organisation

University Maastricht
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone +31 (0)43 388 2446
Email e.habets@caphri.unimaas.nl
Website http://www.caphri.nl/
ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

Research organisation

Partners in Care Solutions (PICASSO) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan