Bringing research to patients home to improve quality of life in palliative care
- 07 October 2024
- 6 min read
Learn how our Agile Research Delivery Teams are delivering decentralised clinical trials through home-based care for patients with advanced liver disease.
The clinical need
Liver disease deaths in England have soared by more than 250% since 1971. Long term liver damage can be caused by excessive alcohol , viral infections and non alcoholic fatty liver disease. In some instances this leads to cirrhosis (scarring of the liver). Patients receiving end of life care for advanced cirrhosis often experience a build-up of fluid (ascites) in the abdomen. This is a common and debilitating complication which causes severe pain and breathlessness.
Currently, standard palliative care requires admission to hospital for the fluid to be drained via a tube into the abdomen. This procedure takes a few hours and reduces the pain from ascites but needs to be repeated every 10-14 days. Both the physical effort required to make the journey, and the procedure itself, are difficult and uncomfortable for patients.
For people with ascites due to cancer (rather than cirrhosis), palliative standard of care differs. It involves placing a long-term abdominal drain (LTAD), into their abdomen. This is fitted in hospital but stays in place for months. Community nurses/caregivers can drain smaller amounts of fluid more frequently without the patient needing to leave home, resulting in better quality of life.
REDUCe2 Study - Bringing research to the home
LTADs are not routinely offered to patients with cirrhosis from long term liver damage for a number of reasons: they may have complicated social issues making community care more difficult; and there is a higher risk of infection due to the cirrhosis.
The REDUCe2 aims to change this. It is assessing the safety, infection risk, and overall impact on quality of life of LTADs delivered at home for this patient group. The outcomes could represent a significant step forward in palliative care for those with long term liver disease.
The research will involve 310 participants across 35 sites in the UK. Participants are recruited and randomised during routine clinic visits by the hospital Hepatology team. Participants randomised to the LTAD arm of the study, require follow-up visits in their own home, which requires out of hospital support. Fortunately, the local Agile Research Delivery teams are on hand to help.
Decentralising trial delivery with Agile Research Delivery support
Clare Aitken is the Agile Research Delivery Team Manager and Senior Manager Social Care Research covering the North East and North Cumbria region. She explains:
“Since our inception, three years ago, we’ve delivered multiple studies in the community which has enabled us to develop processes and hone our approaches. We can confidently support study activities outside of the hospital including recruitment, screening, consenting, intervention, follow up and data entry.”
Managing LTADs in patients' homes, requires meticulous planning and coordination to ensure compliance with regulatory standards. The Agile Research Delivery Teams play a critical role in managing these challenges, ensuring that the study is conducted safely and efficiently.
Participation at home drives recruitment
By enabling the trial in patients' homes, Agile Teams also help to minimise the burden on participants. This approach not only improves patient comfort, but also enhances study retention and outcomes.
"If these patients weren't part of the trial, they would all need to attend secondary care approximately every two weeks, which is a significant ordeal," explains Clare Aitken. "Just getting to the hospital involves several hours of discomfort and pain for them.
“By bringing the treatment to their homes, we're sparing these patients that hardship and significantly improving their quality of life through enhanced symptom management. That’s the core aim of the study—to see if home-based care can offer better quality of life. Also, being able to receive this kind of care at home is encouraging more people to participate in the study because it may provide immediate, tangible help when they need it most."
Additional decentralised delivery considerations
Delivering research in patients' homes requires consideration of wider issues. The Agile Teams have developed strategies to address these issues, drawing on their experience and the soft skills of the multidisciplinary team.
"This kind of research requires a breadth of experience. Our team has to think about safety when they’re deployed into patients' homes, especially when working alone," Clare notes. "It's also crucial to be sensitive to the patients’ emotional state. We have some extremely experienced research nurses, some of whom have worked in palliative care previously, who have been invaluable in ensuring we approach each home visit with the right mindset."
Wider impact of home-based care
The success of the REDUCe2 study so far is highlighting the value of taking research directly to patients. This approach frees up clinical teams to focus on recruitment and other critical tasks. It also brings significant benefits to participants, who often look forward to the visits from research nurses. One caregiver told the Agile team:
“Mum really appreciates the additional company that the research team and the district nurse provide - they always put a smile on her face.”
Decentralising aspects of trial delivery into people’s homes also creates huge potential to reach diverse and often underrepresented demographics.
Clare said: “If a participant group is frail and vulnerable, we should be taking research to them, not asking them to come into secondary care or research sites. It’s really powerful when you can engage with, and improve the quality of life of, people in hard-to-reach or economically challenging areas."
“We are seeing positive impacts on people’s lives from the research delivery alone and the research findings haven’t even been published yet!"
Top tip for sponsors: Turn it upside down
Clare reflects on the progress made by the Agile Research Delivery Team in the three years since its inception:
“I feel very proud when I look at how far we've come and at our ongoing commitment to advancing research delivery. In the North East and North Cumbria alone we’ve successfully delivered more than 80 studies in diverse environments, including care homes, palliative care settings, schools and in people’s homes. This rapid progress highlights our ability to adapt and support various sectors. We're keen to actively collaborate with industry partners to deliver innovative research protocols."
She concludes with the following advice for commercial sponsors:
“Don't start with pre-selected sites, and then worry about how your sites will engage the target demographics.
“By partnering with Agile Teams, early in your research planning, we can co-create protocols that utilise the flexibility and extensive reach of our services.”
Reduce2 has been supported by Agile Research Delivery Teams covering: North East North Cumbria, Wessex, South London, West of England, East Midlands, Yorkshire and Humber and Kent Surrey and Sussex and was also supported by Research Delivery Network staff in Greater Manchester.
Want to know more about Agile Research Delivery?
People also viewed
- Article: 5 tips for expanding your commercial health research studies into diverse settings
- Case study: From festivals to places of worship: Bringing research to South Asian communities
- Case study: Agile Research Delivery Team take LOLIPOP study into the community
- Case study: Agile Research Delivery Teams take the ELSA study into schools
- Case study: Maximising recruitment with mobile research buses - a people centred approach
- More information on delivering research beyond the hospital
Explore more support from the NIHR
This is just one of the ways we help life science organisations. Discover our full range of services and support.