Needs-based innovation for the management of malignant pleural effusions in the palliative care setting

By Dr Michelle Tierney and Tim Jones

Dr Michelle Tierney

The HSE has outlined that one of the major challenges relating to adult palliative care is the growing demand for services due to our ageing population. 

Further to this, cancer-related palliative care is the area requiring the most resources, as shown in figure 1 where in 2011 the leading cause of death in Ireland with known palliative care needs was malignant neoplasms.1

Tim Jones

Given that the incidence of cancer in Ireland is estimated to double by 2040, this has the potential to put significant strain on palliative care resources if innovative measures that can ease the burden are not implemented. 

Figure 1: The incidence of the causes of death with known palliative care needs, in 2007 and 2011 (Credit: Kane et al. 2015)

 

While participating in the BioInnovate Innovation programme at NUIG, Tim Jones and I had the opportunity to visit hospitals in Ireland, and The Mayo Clinic in Minnesota. Using the ‘needs-based’ approach to innovation we observed procedures carried out to diagnose and treat conditions relating to the lungs, many of which were as a result of malignancy.  

We discovered that a secondary condition, known as a pleural effusion, often develops in patients with late-stage cancers affecting approximately 15% of patients. A pleural effusion is the build-up fluid on the lung and can cause significant shortness of breath and chest pain. For many patients with lung and breast cancers, pleural effusions are drained with a catheter and the management of these catheters is generally conducted by palliative care services through in-patient care, hospice care or in-home care. 

Following our time in hospitals engaging with clinicians, nurses and patients, and our own independent research, we hypothesised that the management of pleural effusions in patients with cancer was sub-optimal. We identified a number of areas where the management with catheters is lacking;
- They are associated with a lengthy and unpredictable treatment period (range of catheter dwell time is between 2-434 days), which significantly impacts patients’ quality of life
- A longer catheter dwell time increases healthcare costs as home drainage kits must be provided for ongoing drainage
- Due to the length of time catheters are in place, acute readmissions due to complications, such as dislodgements, infections and blockages, are common
- The patient requires the assistance of a carer or nurse in order to drain each time at home.  

Clinical validation was key in appraising to what degree the management of pleural effusions is being undermet, and we engaged with 30 international Pulmonologists to assess the shortcomings in this area, particularly in relation to clinical outcomes. When Pulmonologists, including specialists in pleural disease management, were asked to rate between 1 and 5 (where 1 is no impact and 5 is a significant positive impact) the importance of shortening the treatment period with a catheter 90% said it would have a positive impact (rating 4) or significant positive impact (rating 5) on clinical outcomes (figure 2). 

Figure 2: Ratings given by Pulmonologists to the impact of shortening the treatment period of pleural effusions with pleural catheters *n=21

 

We also asked clinicians to comment on the rationale for their ratings, and for those that gave a rating of 4 or 5 the following were their verbatim responses, with additional information for context given in brackets:

  • “They [patients] have a short-predicted life span - the quicker the better - drain out and allow QOL [quality of life]” 
  • “Would decrease cost and infection risk”
  • “Yes, this would be of value. One of the best ways to avoid complications is to have a catheter in place for as little time as is necessary” 
  • “More definitive symptom control, liberation from TPC [catheter] and drainage need and expense, likely reduced infection long-term”
  • “Improve QOL [quality of life]” 

In addition to clinical validation, the team are also seeking patient and carer input to gain insights into their everyday experiences and possible challenges with using the current catheters. Engaging in this activity has the potential to provide patients and their carers with a sense of empowerment as it gives them a forum in which they can have their say on what changes they would like to see made to the current standard of care. Also, studies have reported that participant involvement in qualitative research, particularly interviews, may unintentionally become a therapeutic process for participants during their end-of-life stage.2 The information gathered from these end-users will help the team to establish the key criteria that must be addressed in order to design a more user-friendly and comfortable catheter for patients to manage at home as well as providing better clinical outcomes.. 

The HSE have outlined key priority areas to be addressed in relation to improving palliative care services:3
- Maximising value from current resources
- Supporting individuals to remain at home
Our aim is to establish the criteria for an optimum design for a catheter device that has the capabilities to address these priority areas by achieving the ‘Triple Aim’, ie. improving clinical outcomes, bettering the patient experience, and reducing healthcare costs. Figure 3 outlines the specific areas we are aiming to address, for instance:  

  • Shorten the duration of treatment, and liberate the patient sooner from the catheter 
  • Reduce the invasiveness of the catheter insertion procedure
  • Limit acute hospital admissions linked to catheter complications, such as infection and dislodgements 
  • Promote patient independence at home
  • Reduce healthcare costs associated with home drainage kits 
Figure 3: The ‘Triple Aim’ approach to improving malignant pleural effusion treatment with a drainage catheter

 

There have been no major improvements made to catheter devices for managing malignant pleural effusions in over 20 years. The team utilised the ‘needs-based’ innovation approach, which focuses on empathising with clinicians and patients, to identify that the management of malignant pleural effusions was a significantly undermet clinical area. ‘Needs-based’ innovation differs from traditional innovation approaches that are motivated predominantly by clever design and technical solutions but ignore the holistic needs of the end-users. The team will continue to use the ‘needs-based’ innovation approach to establish a catheter design that has the potential to more effectively treat malignant pleural effusions while relieving the palliative care burden and improving patients’ quality of life. 

References

  1. Kane, et al (2015),The Need for Palliative Care in Ireland – a Population-based Estimate of Palliative Care Using Routine Mortality Data, Inclusive of Non-malignant Conditions, Journal of Pain & Symptom Management, Vol. 49, No.4.
  2. Sivell S, Prout H, Hopewell-Kelly N, et al (2015). Considerations and recommendations for conducting qualitative research interviews with palliative and end-of-life care patients in the home setting: a consensus paper. BMJ Supportive & Palliative Care, Published Online First: 08 December 2015. doi: 10.1136/bmjspcare-2015-000892.
  3. Health Service Executive (HSE), Decision-making among patients and their family in ALS care: a reviewPalliative Care Services Three Year Development Framework, (2017 – 2019).

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