Indwelling Pleural Catheters: a Self-management Intervention

NCT ID: NCT06910800

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2026-04-30

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.

Detailed Description

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

• 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
• as above

Exclusion criteria 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
• None Stage 3 - co-design groups
• As above

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:

• Empower patients, increase perceived symptom control, and reduce time spent 'waiting in' for nursing visits;
• Relieve pressure on community nursing services and reduce healthcare costs;
• Support the NHS long term plan by enabling supported self-management;
• Facilitate more frequent drainage which may prevent re-accumulation of pleural fluid.

Conditions

Indwelling Pleural Catheter

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients

Patients who have (or have had) an IPC.

No interventions assigned to this group

Family members and unpaid carers

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

No interventions assigned to this group

Healthcare professionals

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of East Anglia

OTHER

Sponsor Role: collaborator

Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam M Dr Peel

Role: PRINCIPAL_INVESTIGATOR

Norfolk and Norwich University Hospitals NHS Trust

Locations

Norfolk and Norwich University Hospitals NHS Trust

Norwich, Norfolk, United Kingdom

Countries

United Kingdom

Other Identifiers

333923

Identifier Type: REGISTRY

Identifier Source: secondary_id

58382

Identifier Type: REGISTRY

Identifier Source: secondary_id

Pac-man protocol | v1.0 | 14.0

Identifier Type: -

Identifier Source: org_study_id