Indwelling Pleural Catheters: a Self-management Intervention

NCT06910800 | Enrolling By Invitation

• 3 other identifiers: Pac-man protocol | v1.0 | 14.033392358382
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Indwelling Pleural Catheter

Keywords

Indwelling pleural catheter; Tunnelled pleural catheter; IPC; Pleural effusion; Self-management; Support needs

Outcome Measures

Primary Outcomes (1)

• 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.

  Periprocedural

Study Arms (3)

Patients

Patients who have (or have had) an IPC.

Family members and unpaid carers

Family members and unpaid carers of patients who have (or have had) an IPC.

Healthcare professionals

Community nurses involved in IPC care and healthcare professionals involved in IPC insertion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Stage 1 - Patients and family/unpaid carers
• Adult (\>18 years) who has (or has had) an IPC OR
• Adult family member or unpaid carer of a patient who has (or has had) an IPC
• Patients may currently be self-managing or receiving CN care.
• Stage 2 - Healthcare professionals
• Community nurse: experience of caring for a patient with an IPC within the last 12 months and signed-off as competent in IPC management
• IPC-insertion site staff: any HCP involved in discussion with patients about post-insertion IPC care
• Stage 3 - Co-design groups
• o as above

You may not qualify if:

• Stage 1 - Patients
• Patient with a life expectancy of less than 6 weeks
• Patient or family/unpaid carer who lacks capacity to offer informed consent (as judged by a suitably qualified HCP in accordance with Good Clinical Practice guidelines)
• Stage 2 - Health care professionals o None
• Stage 3 - Co-design groups
• o As above

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• University of East Anglia: collaborator

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Adam M Dr Peel

  Norfolk and Norwich University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 4, 2025
• Study Start: November 12, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Throughout study duration.
• Access Criteria: Stakeholders including - but not limited to: * Regional integrated care boards, and participating NHS trusts / study recruitment sites. * Influential third sector organisations such as Mesothelioma UK * IPC manufacturers * Relevant charities such as Breast Cancer UK and the Roy Castle lung cancer foundation. * Via the FutureNHS platform. * Members of the BTS Pleural Guideline Development group

Locations

GB (1)