To investigate whether cough measurements by means of VAS (0-100 points) after 6 months (+/- 6 points) in patients with chronic cough who are diagnosed and treated by a nurse practitioner outpatient clinic are equal to an outpatient clinic leaded by…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. the difference in cough after 6 months in patients with a chronic cough
between the cough outpatient clinic of the pulmonologist and nurse
practitioner.
Secondary outcome
1. the difference in cough scores after 6 months between both groups for LCQ.
2. the difference in HADS scores after 6 months for both groups.
3. the diagnosis of the nurse practitioner vs the pulmonologist.
4. the number and sort of investigations to obtain a diagnosis.
4. the number of patients after 6 months with an increase / decrease of their
complaints (global rating of change questionnaires).
5. patient satisfaction after 6 months.
Background summary
Chronic cough; cough > 8 weeks is a frequently seen problem. Prevalention is
estimated at 20 % and 10 % of the patients is referred to a cough outpatient
clinic with this problem. Three mechanisms are responsible for this phenomenon
in 90% of the cases; asthma, upper tract infection and reflux. This as an
explanation why therapy of chronic cough is so difficult.
In the US and Engeland special cough outpatient clinics with an
anatomic-diagnostic protocol seem to be very effective. In 2004 a cough
outpatient clinic is started in the Isala klinieken in the Netherlands. Since
2004, 600 patients are analysed via this outpatient clinic.
Since the diagnostic and therapeutic program is protocolised, it should be
possible to transition medical care from pulmonologist to nurse practitioner.
An advantage could be that a nurse practitioner is better able to work
throughout the different specialisms.
Study objective
To investigate whether cough measurements by means of VAS (0-100 points) after
6 months (+/- 6 points) in patients with chronic cough who are diagnosed and
treated by a nurse practitioner outpatient clinic are equal to an outpatient
clinic leaded by a pulmonologist.
Study design
Design: prospective randomised single centre trial.
Threehundredandten patients are referred to the cough outpatient clinic from
the primary medical line (GP) with chronic cough (existing >8 weeks) without a
certain diagnosis. Patients will be asked for participation by informed
consent. Inclusion will be during three years and will last 6 months for every
patient.
Exclusion criteria are chronic cough in medical history, analyzed and/or
treated by a pulmonologist, gastro-enterologist or an ear-nose and throat
specialist
and co-morbidity limiting decision making.
Participating patients will be randomised for age and gender by a computer
minimisation program for both groups; cough outpatient clinic by pulmonolgist
or nurse practitioner (experimental group). Patients in both groups will be
analyzed by the same anatomic-diagnostic protocol.
During the first visit questionnaires will be filled in by participating
patients:
- Illness specific quality of life by the dutch version of the Leicester
Cough
Questionnaire.
-The dutch version of the Hospital Anxiety and Depression Scale (HADS).
- the degree of cough in the last 24 hours by means of the Visual Analogue
Scale.
- Baseline characteristics will be noted.
Follow-up
In the first week of every month the VAS will be detected during 6 months,
whereby the average score will be calculated for every week (7 times).The HADS
and LCQ will be performed at the beginning and after 3 and 6 months. Also a
Global Rating of Change questionnaire (GRC) and a patient satisfaction
questionnaire will be filled in after 6 months.
With the medical dossier of the participating patients it will be find out
which diagnosis is obtained and which diagnostic approaches were needed.
Study burden and risks
There are no (additional) risks due to participation. The burden are the
questionnaires; twice the LCQ,HADS,VAS and once patient satisfaction
questionnaire and the GRC questionnaire. An advantage could be that a nurse
practitioner is better able to work throughout the different specialisms.
Groot Wezenland 20
8011 J W Zwolle
Nederland
Groot Wezenland 20
8011 J W Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
1. patients >= 18 years.
2. cough > 8 weeks
3. referred via general practitioner.
Exclusion criteria
1. chronic cough in medical history, treated by a pulmonologist, gastro-enterologist
or ear-nose and throat specialist.
2. co-morbidity limiting decision making.
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 | NL14700.075.06 |