Study protocol: Delayed intervention randomised controlled trial within the Medical Research Council (MRC) Framework to assess the effectiveness of a new palliative care service

Background: Palliative care has been proposed to help meet the needs of patients who suffer progressive non-cancer conditions but there have been few evaluations of service development initiatives. We report here a novel protocol for the evaluation of a new palliative care service in this context. Methods/Design: Using the MRC Framework for the Evaluation of Complex Interventions we modelled a new palliative care and neurology service for patients severely affected by Multiple Sclerosis (MS). We conducted qualitative interviews with patients, families and staff, plus a literature review to model and pilot the service. Then we designed a delayed intervention randomised controlled trial to test its effectiveness as part of phase II of the MRC framework. Inclusion criteria for the trial were patients identified by referring clinicians as having unresolved symptoms or psychological concerns. Referrers were advised to use a score of greater than 8 on the Expanded Disability Scale was a benchmark. Consenting patients newly referred to the new service were randomised to either receive the palliative care service immediately (fast-track) or after a 12-week wait (standard best practice). Face to face interviews were conducted at baseline (before intervention), and at 4–6, 10–12 (before intervention for the standard-practice group), 16– 18 and 22–24 weeks with patients and their carers using standard questionnaires to assess symptoms, palliative care outcomes, function, service use and open comments. Ethics committee approval was granted separately for the qualitative phase and then for the trial. Discussion: We publish the protocol trial here, to allow methods to be reviewed in advance of publication of the results. The MRC Framework for the Evaluation of Complex Interventions was helpful in both the design of the service, methods for evaluation in convincing staff and the ethics committee to accept the trial. The research will provide valuable information on the effects of palliative care among non-cancer patients and a method to evaluate palliative care in this context

Recruiting patients with advanced malignant and non-malignant disease: lessons learned from a palliative care RCT.

RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are

What influenced people with chronic or refractory breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study.

BACKGROUND: Recruitment and retention in clinical trials remains an important challenge, particularly in the context of advanced disease. It is important to understand what affects retention to improve trial quality, minimise attrition and reduce missing data. We conducted a qualitative study embedded within a randomised feasibility trial and explored what influenced people to take part and remain in the trial. METHODS: We conducted a qualitative study embedded within a double-blind randomised trial (BETTER-B[Feasibility]: BETter TreatmEnts for Refractory Breathlessness) designed using a person-centred approach. Participants with cancer, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), or chronic heart failure (CHF), with a modified Medical Research Council dyspnoea scale grade of 3/4 were recruited from three UK sites. A convenience subsample completed qualitative interviews after the trial. Interviews were analysed using thematic analysis. Results were considered in relation to the core elements of person-centred care and our model of the person-centred trial. RESULTS: In the feasibility trial 409 people were screened for eligibility, and 64 were randomised. No participant was lost to follow-up. Twenty-two participants took part in a qualitative interview. Eleven had a diagnosis of COPD, 8 ILD, 2 CHF and 1 lung cancer. The participants' median age was 71 years (range 56-84). Sixteen were male. Twenty had completed the trial, and two withdrew due to adverse effects. The relationship between patient and professional, potential for benefit, trial processes and the intervention all influenced the decision to participate in the trial. The relationship with the research team and continuity, perceived benefit, and aspects relating to trial processes and the intervention influenced the decision to remain in the trial. CONCLUSIONS: In this feasibility trial recruitment targets were met, attrition levels were low, and aspects of the person-centred approach were viewed positively by trial participants. Prioritisation of the relationship between the patient and professional; person-centred processes, including home visits, assistance with questionnaires, and involvement of the carer; and enabling people to participate by having processes in line with individual capabilities appear to support recruitment and retention in clinical trials in advanced disease. We recommend the integration of a person-centred approach in all clinical trials. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN32236160. Registered on 13 June 2016

Symptoms and quality of life in late stage Parkinson syndromes: a longitudinal community study of predictive factors

BACKGROUND Palliative care is increasingly offered earlier in the cancer trajectory but rarely in Idiopathic Parkinson's Disease(IPD), Progressive Supranuclear Palsy(PSP) or Multiple System Atrophy(MSA). There is little longitudinal data of people with late stage disease to understand levels of need. We aimed to determine how symptoms and quality of life of these patients change over time; and what demographic and clinical factors predicted changes. METHODS We recruited 82 patients into a longitudinal study, consenting patients with a diagnosis of IPD, MSA or PSP, stages 3-5 Hoehn and Yahr(H&Y). At baseline and then on up to 3 occasions over one year, we collected self-reported demographic, clinical, symptom, palliative and quality of life data, using Parkinson's specific and generic validated scales, including the Palliative care Outcome Scale (POS). We tested for predictors using multivariable analysis, adjusting for confounders. FINDINGS Over two thirds of patients had severe disability, over one third being wheelchair-bound/bedridden. Symptoms were highly prevalent in all conditions - mean (SD) of 10.6(4.0) symptoms. More than 50% of the MSA and PSP patients died over the year. Over the year, half of the patients showed either an upward (worsening, 24/60) or fluctuant (8/60) trajectory for POS and symptoms. The strongest predictors of higher levels of symptoms at the end of follow-up were initial scores on POS (AOR 1.30; 95%CI:1.05-1.60) and being male (AOR 5.18; 95% CI 1.17 to 22.92), both were more predictive than initial H&Y scores. INTERPRETATION The findings point to profound and complex mix of non-motor and motor symptoms in patients with late stage IPD, MSA and PSP. Symptoms are not resolved and half of the patients deteriorate. Palliative problems are predictive of future symptoms, suggesting that an early palliative assessment might help screen for those in need of earlier intervention

How is place of death from cancer changing and what affects it? Analysis of cancer registration and service data

We aimed to compare trends in place of cancer death with the growth of palliative care and nursing home services, and investigate demographic, disease-related and area influences on individual place of death, using registration data for 216404 patients with breast, lung, colorectal and prostate cancer and aggregate data on services in South East England. Between 1985 and 1994 there was a trend away from hospital death (67–44%), to home (17–30%) and hospice death (8–20%). After 1995, this partly reversed. By 2002, hospital death rose to 47%, home death dropped to 23%, hospice death remained stable and nursing home death rose from 3 to 8%. Numbers of palliative care services increased, but trends for hospice and nursing home deaths most clearly followed the beds available. Cancer diagnosis and treatment influenced individual place of death, but between 1998 and 2002, age and area of residence were associated with most variation. Older patients and those living in more deprived areas died more often in hospitals and less often at home. Despite more palliative care services the proportion of people dying at home has not increased. Variation by age, deprivation and area of residence is unlikely to reflect patient preference. More active surveillance and planning must support policies for choice in end of life care

How many people will need palliative care in 2040? Past trends, future projections and implications for services.

BACKGROUND: Current estimates suggest that approximately 75% of people approaching the end-of-life may benefit from palliative care. The growing numbers of older people and increasing prevalence of chronic illness in many countries mean that more people may benefit from palliative care in the future, but this has not been quantified. The present study aims to estimate future population palliative care need in two high-income countries. METHODS: We used mortality statistics for England and Wales from 2006 to 2014. Building on previous diagnosis-based approaches, we calculated age- and sex-specific proportions of deaths from defined chronic progressive illnesses to estimate the prevalence of palliative care need in the population. We calculated annual change over the 9-year period. Using explicit assumptions about change in disease prevalence over time, and official mortality forecasts, we modelled palliative care need up to 2040. We also undertook separate projections for dementia, cancer and organ failure. RESULTS: By 2040, annual deaths in England and Wales are projected to rise by 25.4% (from 501,424 in 2014 to 628,659). If age- and sex-specific proportions with palliative care needs remain the same as in 2014, the number of people requiring palliative care will grow by 25.0% (from 375,398 to 469,305 people/year). However, if the upward trend observed from 2006 to 2014 continues, the increase will be of 42.4% (161,842 more people/year, total 537,240). In addition, disease-specific projections show that dementia (increase from 59,199 to 219,409 deaths/year by 2040) and cancer (increase from 143,638 to 208,636 deaths by 2040) will be the main drivers of increased need. CONCLUSIONS: If recent mortality trends continue, 160,000 more people in England and Wales will need palliative care by 2040. Healthcare systems must now start to adapt to the age-related growth in deaths from chronic illness, by focusing on integration and boosting of palliative care across health and social care disciplines. Countries with similar demographic and disease changes will likely experience comparable rises in need

Managing clinical uncertainty in older people towards the end of life: a systematic review of person-centred tools.

BACKGROUND: Older people with multi-morbidities commonly experience an uncertain illness trajectory. Clinical uncertainty is challenging to manage, with risk of poor outcomes. Person-centred care is essential to align care and treatment with patient priorities and wishes. Use of evidence-based tools may support person-centred management of clinical uncertainty. We aimed to develop a logic model of person-centred evidence-based tools to manage clinical uncertainty in older people. METHODS: A systematic mixed-methods review with a results-based convergent synthesis design: a process-based iterative logic model was used, starting with a conceptual framework of clinical uncertainty in older people towards the end of life. This underpinned the methods. Medline, PsycINFO, CINAHL and ASSIA were searched from 2000 to December 2019, using a combination of terms: "uncertainty" AND "palliative care" AND "assessment" OR "care planning". Studies were included if they developed or evaluated a person-centred tool to manage clinical uncertainty in people aged ≥65 years approaching the end of life and quality appraised using QualSyst. Quantitative and qualitative data were narratively synthesised and thematically analysed respectively and integrated into the logic model. RESULTS: Of the 17,095 articles identified, 44 were included, involving 63 tools. There was strong evidence that tools used in clinical care could improve identification of patient priorities and needs (n = 14 studies); that tools support partnership working between patients and practitioners (n = 8) and that tools support integrated care within and across teams and with patients and families (n = 14), improving patient outcomes such as quality of death and dying and satisfaction with care. Communication of clinical uncertainty to patients and families had the least evidence and is challenging to do well. CONCLUSION: The identified logic model moves current knowledge from conceptualising clinical uncertainty to applying evidence-based tools to optimise person-centred management and improve patient outcomes. Key causal pathways are identification of individual priorities and needs, individual care and treatment and integrated care. Communication of clinical uncertainty to patients is challenging and requires training and skill and the use of tools to support practice

Randomised controlled trial of a new palliative care service: Compliance, recruitment and completeness of follow-up

<p>Abstract</p> <p>Background</p> <p>Palliative care has been proposed for progressive non-cancer conditions but there have been few evaluations of service developments. We analysed recruitment, compliance and follow-up data of a fast track (or wait list control) randomised controlled trial of a new palliative care service – a design not previously used to assess palliative care.</p> <p>Methods/Design</p> <p>An innovative palliative care service (comprising a consultant in palliative medicine, a clinical nurse specialist, an administrator and a psychosocial worker) was delivered to people severely affected by multiple sclerosis (MS), and their carers, in southeast London. Our design followed the MRC Framework for the Evaluation of Complex Interventions. In phase II we conducted randomised controlled trial, of immediate referral to the service (fast-track) versus a 12-week wait (standard best practice). Main outcome measures were: compliance (the extent the trial protocol was adhered to), recruitment (target 50 patients), attrition and missing data rates; trial outcomes were Palliative Care Outcome Scale and MS Impact Scale.</p> <p>Results</p> <p>69 patients were referred, 52 entered the trial (26 randomised to each arm), 5 refused consent and 12 were excluded from the trial for other reasons, usually illness or urgent needs, achieving our target numbers. 25/26 fast track and 21/26 standard best practice patients completed the trial, resulting in 217/225 (96%) of possible interviews completed, 87% of which took place in the patient's home. Main reasons for failure to interview and/or attrition were death or illness. There were three deaths in the standard best practice group and one in the fast-track group during the trial. At baseline there were no differences between groups. Missing data for individual questionnaire items were small (median 0, mean 1–5 items out of 56+ items per interview), not associated with any patient or carer characteristics or with individual questionnaires, but were associated with interviewer.</p> <p>Conclusion</p> <p>This is the first time a fast track (or wait list) randomised trial has been reported in palliative care. We found it achieved good recruitment and is a feasible method to evaluate palliative care services when patients are expected to live longer than 3–6 months. Home interviews are needed for a trial of this kind; interviewers need careful recruitment, training and supervision; and there should be careful separation from the clinical service of the control patients to prevent accidental contamination.</p> <p>Trial Registration</p> <p>Clinical Trials.Gov NCT00364963</p