An observational study in Indwelling Pleural Catheter, sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust · Observational
A pleural effusion is a build-up of fluid around the lung. In the UK, about quarter of a million people develop a pleural effusion each year. They are usually caused by advanced cancer or heart, kidney, or liver failure. People with a pleural effusion feel breathless and can't do the things they want to. Draining the fluid improves breathlessness and quality of life. This can be done by inserting a semi-permanent tube called an indwelling pleural catheter (IPC). This is drained at home about three times a week.
Drainage is usually done by a community nurse. However, it can be done by the patient or family/unpaid carers - this is called self-management. Self-management gives the patient the freedom to drain their IPC when they need to, without having to wait at home until a nurse is available. It reduces the burden on community nursing services. Despite these benefits, not all patients get the opportunity to self-manage.
The aim of this study is to help more patients self-manage if they want to. We will achieve this through three stages:
Stage 1: We will talk to patients with IPCs as well as their families/carers to find out their views on self-management and what stops people who could self-manage from doing so. We know that patients with an IPC can be frail. Often their families/carers are already doing a lot to support them. We will ask what might help them to self-manage if they would like to.
Stage 2: We will talk to healthcare professionals (HCPs) looking after patients with IPCs to understand what they think about self-management. This will include community nurses and the hospital teams who put IPCs in.
Stage 3: Along with our patients, their families/unpaid carers and HCPs, we will hold workshops to design an intervention that will help people to self-manage IPCs. We don't know what this intervention will look like yet. From talking to patients and families who already self-manage, we have found they like to learn from a demonstration on their own IPC followed by supervised self-management until they feel confident. Therefore, our intervention may include training sessions for HCPs on how to teach self-management.
This study grew from conversations with our patients. People with an IPC, family members and community nurses helped design the study. Our patient and public involvement (PPI) group will help design study materials and guide the study.
Research question:
How can patients with an indwelling pleural catheter (IPC) and their family/unpaid carers be supported to self-manage?
Background:
Pleural effusion is the accumulation of fluid in the space between the lung and chest wall. It is a common complication of malignancy and affects approximately 200-250,000 people annually in the UK. People with such an effusion experience disabling breathlessness; this is treated by draining the fluid using IPCs (semi-permanent chest drains). These are usually managed at home by community nurses, but this can be done by the patient, family member or carer. Supported self-management is part of the NHS long term plan and British Thoracic Society guidelines state that patients should be supported to self-manage their IPC to promote independence. However, there is no evidence to support these recommendations, nor guidance on how self-management should be facilitated. There is thus an evidence gap at the heart of current recommendations.
Objectives:
O1. Identify support needs of patients with IPCs and their family/unpaid carers and how these impact on the acceptability and feasibility of self-management.
O2. Identify barriers and motivators to IPC self-management among patients and family/unpaid carers.
O3. Understand healthcare professional (HCP) attitudes toward, and practices related to, IPC self-management.
O4. Co-design and develop an evidence-based intervention to facilitate IPC self-management.
Methods:
An applied qualitative study and co-design project comprising three stages mapped to the four objectives.
S1: semi-structured interviews with patients with an IPC and their family/unpaid carers regarding self-management and support needs.
S2: focus groups and interviews with community nurses and IPC service staff regarding self-management.
S3: co-design and development of a self-management intervention.
Interviews will be audio- or audiovisual-recorded (with permission), transcribed, and analysed using thematic analysis. Codes will be assigned to text to categorise meanings. Given the lack of prior research, the coding schema will be developed inductively from early transcripts (with reference to literature from other fields), refined and applied to subsequent transcripts. Codes will be categorised, themes identified, and the results developed into a narrative. The COM-B system will be the model of reference for the development of the self-management intervention. This is comprised of a behaviour change wheel linked to intervention functions and policy categories.
Inclusion criteria Stage 1 - patients and family/unpaid carers
Exclusion criteria Stage 1 - patients
Anticipated Impact and Dissemination
The principal output will be a prototype self-management intervention for patients with an IPC and their family/unpaid carers that will:
UK patients who have (or have had) an indwelling pleural catheter, and their family/unpaid carers. UK healthcare professionals who work with patients who have IPCs, including community nurses and IPC-insertion centre staff.
Stage 1 - Patients and family/unpaid carers
Stage 2 - Healthcare professionals
Stage 3 - Co-design groups
o as above
Exclusion Criteria:
Stage 1 - Patients
Stage 2 - Health care professionals o None
Stage 3 - Co-design groups
o As above
Patients who have (or have had) an IPC.
Family members and unpaid carers of patients who have (or have had) an IPC.
Community nurses involved in IPC care and healthcare professionals involved in IPC insertion.
Capturing Health Care Professionals attitudes toward and beliefs about self-management
Data will be collected via focus groups and interviews. The different data collection designs reflect the nature of how the two groups of HCPs work and working patterns. The topic guide for the two activities will thus be largely the same and given the common subject matter it will be possible to analyse the qualitative data from these two approaches together. There will be some additional, group-specific, questions reflecting the different roles these two HCP groups play in the patient care pathway. The four objectives to achieve this are: 1. to identify support needs in relation to IPC and how unfulfilled needs impact ability to self-manage. 2. to identify barriers and motivators to IPC self-management among patients and family/unpaid carers. 3. to understand HCP attitudes toward, and practices related to, IPC-self-management. 4. to work with stakeholders to co-develop an intervention to facilitate IPC self-management.
Time frame: Periprocedural
Plan to share: Yes — The study will be publicised to stakeholders. Online resources may be hosted and promoted via the MyPleuralEffusionJourney and UKPS websites. Further opportunities for promotion will be explored including direct contact with services previously identified as using self-management infrequently.
Supporting information: Csr
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Norfolk and Norwich University Hospitals NHS Foundation Trust