The purpose of this study is to determine the efficacy of an outpatient clinical care on demand in the management of COPD.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. the number of appointments at the outpatient clinic.
2. use of medical care (hospitalizations / ER-visits / visits to GP/
pulmonologist/
need for antibiotics for respiratory upper tract infections).
Secondary outcome
1. patient satisfaction.
2. quality of life (CCQ, SGRQ and SF-36).
Background summary
COPD (chronic obstructive pulmonary disease) is a chronic disease which is
increasing. Patients with COPD are the most important concern of the
pulmonologists. At the outpatient clinic has been observed that the amount of
new and regular COPD patients is of such a size that it seems to overwhelm the
capacity of the outpatient clinic. Solutions could be substitution of medical
care, longer intervals between the appointments or discharge from secondary
medical care to primary care. The first point doesn*t solve the lack of
capacity, the second point is not allowed because it will decrease quality of
care and transition of care is a temporary solution. COPD is a complex disease,
whereby, and certainly in an advanced stadium, multidisciplinary and qualified
expertise is needed.
The optimal control frequency of patients with COPD is unknown. COPD is a
disease with fluctuating activity and complaints over time. There is a chance
that patients are seen at a stable state at the regular outpatient clinical
visits instead of moments when medical care is obligated. The regular
management of the outpatient clinic will therefore result in an ineffective
treatment of COPD patients. In this way general practitioners and even patients
could suggest that visits to the outpatient pulmonary clinic are confounding
less to a good treatment of COPD.
Outpatient clinical care on demand, initiated by patients in other chronic
patient groups like reumatoide arthritis and inflammatory bowel diseases, are
proven to be safe and effective leading to less consumption and costs of
medical care in comparison to standard outpatient clinical visits.
Study objective
The purpose of this study is to determine the efficacy of an outpatient
clinical care on demand in the management of COPD.
Study design
396 patients with at least COPD GOLD II and an age above the 40 years
at the outpatient clinic of the pulmonology department are recruited and will
be
followed-up for two years, after they have given written informed consent. The
inclusion of patients will be during one year.
Inclusion criteria are at least COPD GOLD II, age > 40 years, a smoking history
of
>= 10 pack years and informed consent. Exclusion criteria are significant or
instable
comorbidity, a history of asthma, drug or alcohol abuse, incapacity to fill in
questionnaires, a prior randomisation or an abnormal chest X-ray (findings
other
than fitting with COPD).
Consenting patients will be randomised to regular outpatient clinical care or
outpatient clinical care on demand. Randomisation will take place with the help
of
a computer allocation program to achieve balanced groups for the following
factors: sex, age (< 70 years or >= 70 years) and predicted forced expiratory
volume in one second (FEV1< 40% predicted >= FEV1).
The regular outpatient clinical care patients will be seen by the pulmonologist
in
intervals varying from weeks to one year. The *on demand* patients will be seen
standard once a year and unlimited on their own request. During two years of
follow up the consumption of medical care will be registered. This will
include:
visits to GP, pulmonologist, ER, hospitalizations and the number of
antibiotics
prescribed for upper respiratory tract infections. The quality of life will be
detected by questionnaires at every six months; St. George respiratory
questionnaire (SGRQ), SF-36-scores (short form health survey) and clinical
COPD questionnaire (CCQ). After the accomplishment of the study patients
have to fill in patient satisfaction questionnaires.
Intervention
COPD patients with at least GOLD II with an age > 40 years will be seen at
the outpatient clinic on demand; at least once a year and on request of the
patient.
Study burden and risks
The advantages could be that an outpatient clinic on demand is safe and
costeffective with at least equal quality of life; leading to less consumption
of
medical care in comparison to the standard outpatient clinic. Patients could be
more content.
The most important disadvantage might be that by some COPD patients the
insight of illness is lacking resulting in a delay in visiting the outpatient
clinic.
Another disadvantage could be that these patienst could accumulate at the
primary medical care; a shift of the problem (GP).
The burden is to fill in all the 15 questionnaires about quality of life and
the
evaluation forms of patient satisfaction at the end.
Groot Wezenland 20
8011 J W Zwolle
NL
Groot Wezenland 20
8011 J W Zwolle
NL
Listed location countries
Age
Inclusion criteria
1. COPD patients at least GOLD II (FEV1 < 70%, FEV1/VC ratio <70%).
2. age > 40 years.
3. smoking history > 10 pack years.
4. informed consent.
Exclusion criteria
1. significant or instable comorbidity.
2. a history of asthma.
3. drug or alcohol abuse.
4. incapacity to fill in questionnaires.
5. prior randomisation.
6. abnormal chest X-ray (findings other than fitting with COPD).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL14887.075.07 |