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Study protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

Title: Study protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease
Authors: Farquhar, MC
Prevost, AT
McCrone, P
Higginson, IJ
Gray, J
Brafman-Kennedy, B
Booth, S
Item Type: Journal Article
Abstract: Background Breathlessness in advanced disease causes significant distress to patients and carers and presents management challenges to health care professionals. The Breathlessness Intervention Service (BIS) seeks to improve the care of breathless patients with advanced disease (regardless of cause) through the use of evidence-based practice and working with other healthcare providers. BIS delivers a complex intervention (of non-pharmacological and pharmacological treatments) via a multi-professional team. BIS is being continuously developed and its impact evaluated using the MRC's framework for complex interventions (PreClinical, Phase I and Phase II completed). This paper presents the protocol for Phase III. Methods/Design Phase III comprises a pragmatic, fast-track, single-blind randomised controlled trial of BIS versus standard care. Due to differing disease trajectories, the service uses two broad service models: one for patients with malignant disease (intervention delivered over two weeks) and one for patients with non-malignant disease (intervention delivered over four weeks). The Phase III trial therefore consists of two sub-protocols: one for patients with malignant conditions (four week protocol) and one for patients with non-malignant conditions (eight week protocol). Mixed method interviews are conducted with patients and their lay carers at three to five measurement points depending on randomisation and sub-protocol. Qualitative interviews are conducted with referring and non-referring health care professionals (malignant disease protocol only). The primary outcome measure is 'patient distress due to breathlessness' measured on a numerical rating scale (0-10). The trial includes economic evaluation. Analysis will be on an intention to treat basis. Discussion This is the first evaluation of a breathlessness intervention for advanced disease to have followed the MRC framework and one of the first palliative care trials to use fast track methodology and single-blinding. The results will provide evidence of the clinical and cost-effectiveness of the service, informing its longer term development and implementation of the model in other centres nationally and internationally. It adds to methodological developments in palliative care research where complex interventions are common but evidence sparse. Trial Registration ClinicalTrials.gov: NCT00678405
Issue Date: 20-May-2011
Date of Acceptance: 20-May-2011
URI: http://hdl.handle.net/10044/1/72004
DOI: https://dx.doi.org/10.1186/1745-6215-12-130
ISSN: 1745-6215
Publisher: BioMed Central
Journal / Book Title: Trials
Volume: 12
Copyright Statement: © 2011 Farquhar et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Sponsor/Funder: NIHR Research for Patient Benefit
Funder's Grant Number: PB-PG-0107-11134
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
OBSTRUCTIVE PULMONARY-DISEASE
QUALITY-OF-LIFE
LUNG-CANCER
PALLIATIVE CARE
SYMPTOMS
REHABILITATION
DYSPNEA
IMPROVE
Caregivers
Combined Modality Therapy
Cost-Benefit Analysis
Dyspnea
England
Health Care Costs
Humans
Neoplasms
Palliative Care
Patient Care Team
Research Design
Single-Blind Method
Stress, Psychological
Time Factors
Treatment Outcome
Waiting Lists
Humans
Neoplasms
Dyspnea
Treatment Outcome
Combined Modality Therapy
Palliative Care
Single-Blind Method
Stress, Psychological
Research Design
Time Factors
Caregivers
Cost-Benefit Analysis
Health Care Costs
Waiting Lists
Patient Care Team
England
Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
OBSTRUCTIVE PULMONARY-DISEASE
QUALITY-OF-LIFE
LUNG-CANCER
PALLIATIVE CARE
SYMPTOMS
REHABILITATION
DYSPNEA
IMPROVE
General & Internal Medicine
Cardiovascular System & Hematology
1102 Cardiorespiratory Medicine and Haematology
1103 Clinical Sciences
Publication Status: Published
Article Number: 130
Appears in Collections:School of Public Health