LymphAssistTM at home
Research type
Research Study
Full title
Investigating Value-Based Procurement and patient reported outcomes from adults with lymphoedema using a 12-week home-based programme of LymphAssistTM (intermittent pneumatic compression)
IRAS ID
311663
Contact name
Marie Gabe-Walters
Contact email
Sponsor organisation
Swansea Bay University Health Board
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Summary of Research
Lymphoedema is a life-long condition causing long-term swelling. Lymphoedema mainly affects the extremities (arms / legs) and can occur at any age, affecting people physically, mentally and socially. Usual care focuses on life-long and daily self-management over four main areas (skin care, movement / exercise, compression and massage / light touch). Intensive clinic-based treatments are available alongside usual care. For example, a type of air Pump which automatically inflates and deflates a special garment that is worn over the swollen area helps move the lymph (fluid associated with the swelling) to offer comfort and reduce pain.
However, Lymphoedema Services in Wales only offer using the Pump in a clinic setting, despite reports suggesting that home use is helpful. To know more about this, this study will look to see if home use:
• Improves clinical and patient reported outcomes
• Is a good use of time and costs (efficient)
• Provides benefits that outweigh the cost of buying the Pump
This study will recruit 40 patients with lymphoedema to use the Pump daily at home for 12-weeks alongside their usual care. Participants will volunteer to take part through their Lymphoedema Service. Written consent will be required; however, participants can change their mind and this will not affect their care.
Information will be collected before and after the study including clinical measures (swelling, skin problems), patient outcomes (symptoms, quality of life) and experience. The study will compare the costs of buying the Pump with any benefits gained or costs avoided (less infections or hospital care). Participants will also be offered the chance to talk about their experiences of using the Pump during an interview.
Findings will be shared by publication and presentation. If the benefits are shown, lymphoedema services might be able to provide the Pump for routine use at home through Value-Based procurement.Summary of Results
Background Lymphoedema is a chronic condition that causes long-term swelling. It can be present from birth or can happen later in life, often because of damage to the lymphatic system. Usually this swelling occurs in the legs, but can also happen elsewhere in the body. Many people living with lymphoedema report physical, emotional and social challenges. Life-long self-management with support from lymphoedema therapists, family members and carers can help manage lymphoedema and reduce the risk of complications like cellulitis (skin infection). Self-management includes daily skin care, movement or activity, compression and light touch massage; along with clinic-based intensive treatments to help improve outcomes for patients.
Introduction
Advanced intermittent pneumatic compression (IPC) is one type of intensive treatment used alongside usual self-management. IPC has been shown to help reduce limb volumes and improve patient’s health-related quality of life. LymphAsssitTM is the name of the IPC device used by lymphoedema services in Wales. IPC has two main parts: an air pump and an inflatable attachment that is worn on the affected limb(s). The air pump inflates the attachment in a set order so that it provides a massage that is similar to a type of massage called manual lymphatic drainage (MLD) that is delivered by trained therapists. This helps move the fluid within the swelling to the middle of the body so that it can be removed from the body by normal bodily processes.
Currently, funding is only available for clinic-based IPC, however, we know attending clinic several times a week can be challenging for patients. Building on this, recent studies have shown a benefit for patients using IPC at home. As lymphoedema services in Wales offer a value-based model of healthcare it is key to understand the value of home-based IPC alongside usual care before funding for home-use can be considered. This kind of study is known as a value-based procurement study. Ethical approval was gained for this study (22/WA/0068 IRAS 311663, HRA & HCRW Approval 14.04.2022) registered on clinicaltrials.gov.
Study aims
To understand the costs, benefits and experiences of home-based IPC alongside usual lymphoedema care. This value will be examined for patients and healthcare services.
Methods
Forty participants (adults with arm or leg lymphoedema) across Wales were invited to use IPC at home for 12-weeks. Participants were asked to use IPC daily for a 45-minute session alongside their usual lymphoedema care. Participants could also choose to use the IPC more or less often, whilst writing about each use in a paper diary. Participants also recorded their daily compression garment wear and any issues with the diary collected at the end of the study. A mid-way six-week check-in call from the study team to each participant provided oversight of progress and offered an opportunity for any questions or concerns to be addressed. Study information were collected before and after participants used IPC so that the study could report on value in many different ways:
• Value for patient (e.g. impact of quality of life, limb volume, severity of lymphoedema and experiences of home-based IPC)
• Direct costs of the IPC devices (pounds sterling £, comparing costs for home and clinic IPC use)
• Wider costs to the NHS and social care (pounds sterling £, such as costs with seeing GP for a skin infection or social care at home).
This information was collected using standardised questioning, observations and measurements using forms like the LYMPROM©, EQ5D-5L and LYMPREM©.
At the end of the 12-weeks, a small group of participants (up to 15) were invited to take part in a semi-structured interviews (one to one talks with key questions prepared in advance) to understand their experiences.
Results
Forty participants were recruited and the average age was 62 years old. Most were female (33/40, 83%) with over half (25/40, 63%) treating their arms (legs, 15/40, 37%). Frailty captured at the start of the study indicated that eight participants (20%) were vulnerable to severely frail. Of the 40 participants recruited, one person withdrew from the study (reporting no need for the study as their lymphoedema was well controlled). Another participant continued in the study, but used the IPC for the first few weeks only (reporting that they found it uncomfortable using the arm sleeve but wanted to continue with the study). Where relevant the results do not include these two participants. Thirteen participants were recruited to take part in an interview.
Patient reported outcomes significantly improved with average LYMPROM© scores reducing from 45% to 39% (n=39). A significant result can mean the results are likely to be explained by participants using IPC in the study, rather than by chance. Non-significant can thus mean the results may be explained by chance. Whilst not significant, healthcare costs also reduced at the end of the study (average £2,118 to £550). There was minimal changes in EQ5D-5L scores pre and post IPC use. There were no significant changes in limb volumes from start to end of the study. This was looked at in different ways as lymphoedema was present in different parts of the body for the participants. For example, some had lymphoedema in their arms (24) only and others in their legs (12). There was a reduction in limb volume for both groups of participants but again, this result was not-significant. Diary information showed that participants used IPC for between 42-84 days (n=37) during the study, with some participants choosing to use the IPC several times a day. Over the 12-weeks, an average of 92 IPC sessions (of 45 minutes) was recorded per participant. Participants continued their usual care and just over half wore their compression during their IPC sessions. Based on the target to recruit 40 patients using IPC for 12-weeks, home use of IPC costed £5,368 with a clinic equivalent exceeding £113,000 for staff time alone.
Patient reported experiences were positive covering choices in treatment and being involved in their care. Interview data also showed that participants felt an overall benefit to themselves and this benefit was described in a way that they felt wasn’t always shown in the volume measurements. Most participants described a willingness to ‘try anything’ to help manage their lymphoedema. Generally, participants found it easy to use the IPC; however, some described challenges, particularly needing help to set up.
The study collected information about problems (adverse events) during the study. A small number of participants (4) developed cellulitis (a skin infection), which can be seen in patients with lymphoedema. All episodes were managed according to guidelines with participants taking a break from IPC until they felt well enough. The episodes of cellulitis were not considered directly related to IPC use. Two other participants reported short-lived changes in sensation (one due sitting with arm raised on table during use and another due to previous stroke). One possible bone fracture was reported by a participant, which was not related to the study.
Understanding the results
A reduced impact of lymphoedema in LYMROM© and its items, including body image, pain and home life, represents value to participants. Unexpectedly, some participants felt empowered and reported buying new clothes during the study, perhaps in part owing to an improved body image. A small number of LYMROM© items (such as personal care and intimacy) worsened, though this was not significant. The interview information provides some ideas on this with many participants reporting spending more time providing personal care (looking after their lymphoedema) or having assistance from their spouse to use the IPC. Likewise, carers and family helped to ensure frail participants were able to use the IPC at home. Despite spending more time to look after their lymphoedema, the time spent using IPC was also seen as positive and relaxing when explored in the interviews. Many reported that this time for self-care and relaxation improved their overall wellbeing. Moreover, many participants chose to set up the IPC in their bedroom, which in itself might impact on intimacy. Whilst not identified in the interviews, it would be interesting to explore the potential impact that changes in body image might have on intimacy.
Limb volumes did not significantly reduce after IPC use. This might be in part because of changes in the underlying structure of the tissues (e.g. fibrotic tissues) or in part because of a range of reported IPC use and wearing of compression garments alongside use. Several of the study participants also travelled with their IPC for work and pleasure. Whilst others chose to take a break from IPC for such events. This study was developed to reflect a real-world context where patients are unlikely to be able to sustain a prescribed regime of daily IPC use and this finding is informative. Likewise, interview data highlighted that participants needed to be able to fit their IPC with their commitments and lifestyles. For some participants, volume measurements were not necessarily considered the most important outcome for them. Despite this, participants also reported feeling let down by not achieving the reductions they had hoped for. This was also reflected in a desire from many participants to try a new lymphoedema care option, or to add to their current lymphoedema care toolkit.
The interview phase of the study also identified some of the challenges of IPC home use. Particularly, some participants required help from their family to set up their IPC, whilst others found the air pump and attachment bulky or awkward to use. However, overall, IPC was well tolerated with minimal issues reported by participants. An overall reduction in lymphoedema related healthcare costs is positive. Comparing the costs of home and clinic delivery of IPC in this study, staff costs were reduced for home-based services. Increased costs for clinic use was reflected in longer time in clinic with patients, along with use of clinic space. With interview and outcome data also describing the potential impact of lymphoedema and its management on work attendance and productivity, having home-based IPC provided flexibility and convenience. IPC at home is shown to be of value with an average mean cost reduction in £1,568 for healthcare costs.
Conclusion
Taking stock, this study finds that home-based IPC offers value-based care. Whilst initial purchase costs are high, these are mitigated by the IPC devices lasting a number of years for numerous patients, alongside reduced healthcare costs. In freeing up lymphoedema clinic and staff time using IPC, this might afford a further benefit to lymphoedema services: freeing capacity to deliver therapist-led intensive treatments such as multi-layer bandaging. Offering home-based treatment options provides a feasible solution that can help patients with lymphoedema. More research is needed to now explore education needs of therapists offering IPC services. In response to this study Lymphoedema Wales has now begun to pilot routine home-based IPC for patients, with keen uptake from patients across Wales.REC name
Wales REC 2
REC reference
22/WA/0068
Date of REC Opinion
15 Mar 2022
REC opinion
Favourable Opinion