Immediate versus delayed short-term integrated palliative care for advanced long-term neurological conditions: the OPTCARE Neuro RCT

Abstract

Background Palliative care is recommended to help meet the needs of patients with progressive non-cancer conditions, such as long-term neurological conditions. However, few trials have tested palliative care in this population. Objectives To determine the effectiveness and cost-effectiveness of short-term integrated palliative care in improving symptoms, improving patient- and caregiver-reported outcomes and reducing hospital use for people severely affected by long-term neurological conditions. Design Pragmatic, randomised controlled, multicentre, fast-track trial, with an embedded qualitative component and surveys. Setting Seven UK centres (South London, Nottingham, Liverpool, Cardiff, Brighton, Ashford and Sheffield) with multiprofessional palliative care teams and neurology services. Participants People living with multiple sclerosis, idiopathic Parkinson’s disease, motor neurone disease, multiple system atrophy or progressive supranuclear palsy, with unresolved symptoms and/or complex psychosocial needs. The qualitative study involved patients, caregivers and health-care staff. Interventions Participants were randomised to receive short-term integrated palliative care, delivered by multiprofessional teams, immediately or after a 12-week wait (standard care group). Main outcome measures The primary outcome was a combined score of eight symptoms measured by the Integrated Palliative care Outcome Scale for Neurological conditions 8 symptom subscale (IPOS Neuro-S8) at 12 weeks. Secondary outcomes included patients’ other physical and psychological symptoms, quality of life (EuroQol-5 Dimensions, five-level version), care satisfaction, caregiver burden, service use and cost, and harms. Data were analysed using multiple imputation, generalised linear mixed models, incremental cost-effectiveness ratios (threshold was the National Institute for Health and Care Excellence £20,000 per quality-adjusted life-year) and cost-effectiveness planes. Qualitative data were analysed thematically. Results We recruited 350 patients and 229 caregivers. There were no significant between-group differences for primary or secondary outcomes. Patients receiving short-term integrated palliative care had a significant improvement, from baseline to 12 weeks, on the primary outcome IPOS Neuro-S8 (–0.78, 95% confidence interval –1.29 to –0.26) and the secondary outcome of 24 physical symptoms (–1.95, 99.55% confidence interval –3.60 to –0.30). This was not seen in the control group, in which conversely, care satisfaction significantly reduced from baseline to 12 weeks (–2.89, 99.55% confidence interval –5.19 to –0.59). Incremental cost-effectiveness ratios were smaller than the set threshold (EuroQol-5 Dimensions index score –£23,545; IPOS Neuro-S8 –£1519), indicating that the intervention provided cost savings plus better outcomes. Deaths, survival and hospitalisations were similar between the two groups. Qualitative data suggested that the impact of the intervention encompassed three themes: (1) adapting to losses and building resilience, (2) attending to function, deficits and maintaining stability, and (3) enabling caregivers to care. Conclusions Our results indicate that short-term integrated palliative care provides improvements in patient-reported physical symptoms at a lower cost and without harmful effects when compared with standard care. Limitations Outcome measures may not have been sensitive enough to capture the multidimensional changes from the intervention. Our surveys found that the control/standard and intervention services were heterogeneous. Future work Refining short-term integrated palliative care and similar approaches for long-term neurological conditions, focusing on better integration of existing services, criteria for referral and research to improve symptom management. Trial registration Current Controlled Trials ISRCTN18337380. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 36. See the NIHR Journals Library website for further project information.

Palliative Care Intervention Trials for Adults Living With Progressive Central Nervous System Diseases and Their Caregivers: A Systematic Review

“…Another RCT published results and analyses in 2 different publications. 25,34 Three Cochrane review [14][15][16] and 1 systematic review 17 were also identified and screened for any additional RCTs. One RCT 22 met this review's inclusion/exclusion criteria, yielding a total of 5 RCTs for qualitative synthesis.…”

“…Of the 3 phase II RCTs, 2 enrolled people living with MS and their caregivers (in London, England and 3 locations in Italy, respectively) and the third enrolled people living with MS, motor neuron disease or a movement disorder and their caregivers in Turin, Italy. 30,21,22,23 Of the 2 phase III trials; 24,25,34 there was a pragmatic design study investigating an outpatient integrated palliative care model of delivering PCI in an outpatient movement disorder clinic setting at 3 different academic centers ( 2 in the United States and 1 in Canada). 24 and the other investigated specialty palliative care delivered as a brief, targeted PCI in the outpatient setting for patients and their caregivers already receiving primary medical and specialty neurologic care for MS, motor neuron disease or a movement disorder at one of 7 different sites across the United Kingdom.…”

“…24 and the other investigated specialty palliative care delivered as a brief, targeted PCI in the outpatient setting for patients and their caregivers already receiving primary medical and specialty neurologic care for MS, motor neuron disease or a movement disorder at one of 7 different sites across the United Kingdom. 25,34 The palliative care domains as defined by the National Consensus Project for Quality Palliative Care publication Clinical Practice Guidelines for Quality Palliative Care, 4 th edition 35 incorporated by each of the 5 RCTs are summarized in Table 3. The number of domains incorporated ranged from 4 to 6 without correlation to phase, study size, study population or palliative care delivery model.…”

“…The number of domains incorporated ranged from 4 to 6 without correlation to phase, study size, study population or palliative care delivery model. Four RCTs (all 3 phase II trials and 1 phase III trial) investigated specialty palliative care model of PCI delivery and conducted their PCT visits at the patients' homes [21][22][23]25,[30][31][32][33][34] with 2 studies also accommodating visits in other medical settings as warranted 21,25,[30][31][32]34 although only 1 specifying how often this occurred. 32 However, only 3 of these 4 specialty palliative care model studies employed palliative medicine trained physicians and nurses in their interdisciplinary PCTs 21,22,25,30,[32][33][34]36 as 1 study's PCT physician members were neurologists or physiatrists.…”

“…The duration of the PCI ranged from 3 to 6 months across the 5 RCTs. [21][22][23][24][25][30][31][32][33][34] The frequency of encounters involving at least 2 PCT members during the PCI timeframe ranged from weekly during a 16-week intervention timeframe 22 to twice in a 6-month intervention frametime. 24 The control arms in 4 of the 5 studies were to receive the same specialty palliative care services as the intervention arm after the primary outcome assessment.…”