Aim of this study is to evaluate the procedure of early assisted discharge is effective and cost-effective compared to regular hospital care.The following research questions are drawn for this:1) Does clinical control, as measured with the Clinical…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the score on the CCQ measured on day 7. This score
represents the change in health status.
Secondary outcome
Secondary outcomes are:
* number of treatment failures during the first week (patients that went on
assissted discharge but their condition deteriorated requiring re-admission
* health care utilization
* costs
* CCQ score at 3 months
* 3-months re-admission rate
* 3-months mortality rate
* EQ-5D measured on day 7 and at 3 months
* patient and caregiver satisfaction measured with a dutch translation of the
COPD Project East Yorkshire Hospitals NHS Trust-Medical Chest Unit
questionnaire.
Background summary
COPD is a pulmonary disease that is often accompanied with frequent
exacerbations that require hopsitalization. Because of an aging Dutch society,
the prevalence of COPD will increase. Because of this, the pressure on
hospital's bed-capacity will increase also, and therefore it is neccessary to
develop new treatment concepts. One of these concepts is early assisted
discharge of hospitalizations due to COPD exacerbations. It is a concept that
has already been performed abroad (mainly in the UK) and has proven to be
effective and safe.
Study objective
Aim of this study is to evaluate the procedure of early assisted discharge is
effective and cost-effective compared to regular hospital care.
The following research questions are drawn for this:
1) Does clinical control, as measured with the Clinical COPD Questionnaire,
differ between early discharged patients and those who remain in hospital and
are discharged at the usual time?
2)Do overall costs of the two treatments differ?
3)Does the number of treatment failures during the first 7 days differ between
the two treatment modalities?
4)Do early discharged patients have different re-admission rates compared with
those who remain in hospital and are discharged at the usual time?
5)Do early discharged patients have different mortality rates compared to those
who remain in hospital and are discharged at the usual time?
6)Does patient satisfaction and prefence for place of care differ between the
two treatment modalities?
Study design
This study is a 3-months, prospective, randomised controlled, multi-center
trial, comparing regular hospital care for COPD exacerbations to early assisted
discharge.
Informed consent is asked at the first day of hospital admittance, and obtained
before day three. The first three days all patient receive the usual hospital
care. On day three clinical stability is evaluated using predetermined
criteria. If the patient meets the criteria he will be randomised to either the
intervention group that will be early assisted discharged on day 4 of
addmittance, or the control group that remains hospitalized and receives
regular care. The group that is discharged home receives care of a respiratory
nurse.
Randomisation will be perfomed with a ratio of 1:1 using computer generated
numbers.
On day 7 treatment is finished for both groups, after which a follow up will
take place after 3 months.
Intervention
The intervention group will be transferred home on day 4 of the admission. The
control group remains hospitalized and receives the regulare care.
The intervention group receives care of a respiratory nurse 1 (maximum of 3)
times)a day. The respiratory nurse provides the same care as would be provided
in the hospital (support in ADL activities, guidance etc.).
On day 7 the treatment ends for both groups.
Study burden and risks
Foreign studies have shown that early assisted discharge and home treatment is
just as safe as regular hospital care.
It is possible that despite the assessment of suitability for early assisted
discharge, that patients respond insufficiently to the treatment and
re-admission is neccesary.
The burden for patients minimal and is limited to filling in questionnaires.
postbus 93 245
2509 AE Den Haag
NL
postbus 93 245
2509 AE Den Haag
NL
Listed location countries
Age
Inclusion criteria
*>18 years an competent
*moderate/severe exacerbation of COPD
* written informed consent
Exclusion criteria
* live-threated an clinically unstable condition
* major uncontrolled co-morbidity
* mental disability
* active alcoholism and drug abuse
* inability to understand the program
* living outside the region of care of home care organisation
* admission to the intensive care unit
* indication for NIPPV
* insufficient direct caregiver
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 | NL18298.060.07 |