Breathless Patients With Any Established Underlying Medical Diagnosis Clinical Trial
Official title:
Development,Effectiveness and Cost-effectiveness of a New Respiratory and Palliative Care Out-patient Breathlessness Support Service
Breathlessness is a common, distressing symptom in advanced malignant and non malignant
disease, and impacts significantly on quality of life. Breathlessness in end stage disease
is also responsible for significant healthcare resource usage. Escalante [1] reported
hospital admission rates of 60% in patients presenting to a cancer treatment centre with
breathlessness. Preliminary trials of breathlessness clinics with selected groups of
patients have been promising, but lack data on their cost effectiveness.
The principal aim of the research is to develop and evaluate the effectiveness and cost
effectiveness of a multidisciplinary outpatient breathlessness support service (BSS) for the
palliation of breathlessness, in advanced malignant and non malignant disease. This is a
phase II study that aims to test the hypothesis that a BSS will improve patient mastery over
breathlessness and reduce the use of healthcare resources (including GP
consultations,accident and emergency attendances, and length of hospital stay) compared with
usual best medical care alone (UC),at an acceptable level of cost effectiveness.The outcomes
of this study will also help to determine sample size,develop and test methods for a phase
III trial that will follow on from this project.
This study will run over 2 years. Breathless patients with advanced malignant and non
malignant disease who have already been optimally medically managed will be eligible.
The service will be run in the outpatient department of King's College Hospital, and
patients will also be assessed in their own home and by telephone interviews. At baseline we
will assess respiratory function and breathlessness mastery and severity using validated
scales, and health service usage. Individuals will be randomised to the intervention group
[IG] (n=55) or UC (n=55). The IG will attend the new outpatient clinical service with
multiprofessional input. Assessments will be repeated at 4, 10 & 24 weeks.
1.Escalante, C.P., Martin, C.G., Elting, L.S. et al., Dyspnea in cancer patients. Etiology,
resource utilization, and survival implications in a managed care world. Cancer, 1996.
78(6): p. 13149.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research