Phase II Pilot Pragmatic Single-Blinded Fast Track Randomised Controlled Trial of the Breathlessness Intervention Service Versus Standard Care for Patients With Chronic Obstructive Pulmonary Disease

The aim of the study is to test the feasibility of conducting a pragmatic single-blinded fast track RCT of BIS versus standard care for patients with COPD and their carers and to begin testing the effectiveness of the intervention by: (1) Describing the referral patterns and activity of the service; (2) Describing the experiences and views of the service by people with breathlessness who have been referred to it and the experiences and views of those informally involved in their care; (3) Identifying those aspects of the service which are most useful to people with breathlessness, those informally involved in their care and health care professionals.

The study consists of five components: (1) data relating to referral patterns and service activity; (2) identification of components of the intervention; (3) a pilot pragmatic fast-track randomised controlled trial (RCT) of BIS for COPD patients versus standard care; (4) semi-structured interviews with referrers; (5) in-depth interviews with BIS staff. The RCT is described below.

Although the BIS also receives referrals for patients with cancer and heart failure, COPD patients make up the largest diagnostic group of referrals. The pilot trial therefore focuses on a heterogeneous cohort of COPD/COAD patients.

The investigator will be blinded to the allocation of respondents until week 8. This will be achieved by the investigator conducting the recruitment to the study and collecting baseline measures, but then passing the process of randomisation and reporting of allocation (to the patient and provider) over to a third party (clinical trials' nurses) using a random sequence of opaque envelopes previously generated by a study administrator at King's (independent of the service and the RCT). Subsequent to this, all data will be handled using study identity numbers and group allocation identifiers will only be added at the analysis stage. Outcomes are all self-assessed by patients and carers principally using structured questionnaires but also incorporating a qualitative topic guide prior to randomisation and then again at the end of the fast track group's exposure to BIS and the control group's waiting period for BIS (at both of these measurement points structured questionnaires will be completed prior to the qualitative interview).

Subsequent data collected from the control group once they are in receipt of BIS (after their period on the waiting list when their group allocation was blinded to the investigator) will be treated as before/after data and not RCT data. This will allow the collection of qualitative data at the midpoint of using the service as the investigator will no longer be blinded to their group allocation, nor will she be required to be at this stage.