The feasibility of a randomised controlled trial to compare the cost-effectiveness of palliative cardiology or usual care in people with advanced heart failure: Two exploratory prospective cohorts

Johnson, Miriam J.; McSkimming, Paula; McConnachie, Alex; Geue, Claudia; Millerick, Yvonne; Briggs, Andrew; Hogg, Karen

doi:10.1177/0269216318763225

Cited by 12 publications

(29 citation statements)

References 40 publications

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“…The four single-arm cohort studies could not be assessed fully as there is no non-exposed group. Most cohort studies had representative samples; however, Taylor et al 38 recruited male veterans only and the second cohort in Johnson et al 31 used a convenience sample only. None of the included studies measured the outcome of interest at baseline, but these were expected to improve or worsen based on exposure rather than appear or disappear.…”

Section: Resultsmentioning

confidence: 99%

“…Comparability could be assessed through the baseline characteristics of the included participants, but analyses did not control for confounding factors. The primary objective for Johnson et al 31 was to test the feasibility of a subsequent trial with regard to recruitment, attrition and data quality from these two settings and was not designed to compare the two groups in any way other than descriptively.…”

Section: Resultsmentioning

confidence: 99%

“…There was a significant improvement in New York Heart Association classes from baseline following the intervention, 22,38 but no change in functional status measured by Palliative Performance Scale 27 or Australian-modified Karnofsky Performance Scale. 31…”

Section: Resultsmentioning

confidence: 99%

“…There was no significant difference in hospice use among the participants. Patients in the intervention arm were more likely to complete advance care planning 26,30,31 and less likely to die in hospital. 34,40 Three studies 34,35,40 found a statistically significant drop in costs in the intervention arm, one feasibility study found preliminary cost savings in the intervention group 31 ; however one found no significant difference and the expenditure of the intervention arm in Blecker et al 42 was significantly higher when adjusted for covariates.…”

Section: Resultsmentioning

confidence: 99%

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Multi-disciplinary palliative care is effective in people with symptomatic heart failure: A systematic review and narrative synthesis

et al. 2019

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Background: Despite recommendations, people with heart failure have poor access to palliative care. Aim: To identify the evidence in relation to palliative care for people with symptomatic heart failure. Design: Systematic review and narrative synthesis. (PROSPERO CRD42016029911) Data sources: Databases (Medline, Cochrane database, CINAHL, PsycINFO, HMIC, CareSearch Grey Literature), reference lists and citations were searched and experts contacted. Two independent reviewers screened titles and abstracts and retrieved papers against inclusion criteria. Data were extracted from included papers and studies were critically assessed using a risk of bias tool according to design. Results: Thirteen interventional and 10 observational studies were included. Studies were heterogeneous in terms of population, intervention, comparator, outcomes and design rendering combination inappropriate. The evaluation phase studies, with lower risk of bias, using a multi-disciplinary specialist palliative care intervention showed statistically significant benefit for patient-reported outcomes (symptom burden, depression, functional status, quality of life), resource use and costs of care. Benefit was not seen in studies with a single component/discipline intervention or with higher risk of bias. Possible contamination in some studies may have caused under-estimation of effect and missing data may have introduced bias. There was no apparent effect on survival. Conclusion: Overall, the results support the use of multi-disciplinary palliative care in people with advanced heart failure but trials do not identify who would benefit most from specialist palliative referral. There are no sufficiently robust multi-centre evaluation phase trials to provide generalisable findings. Use of common population, intervention and outcomes in future research would allow meta-analysis.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Multi-disciplinary palliative care is effective in people with symptomatic heart failure: A systematic review and narrative synthesis

et al. 2019

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“…In clinical trials, reference is often made to evaluating the outcomes of an intervention compared with standard care. 76,77 Few studies, however, explain what this type of care comprises or examine the extent to which standard care changes during the trial as a result of involvement in the trial. This methodological issue was highlighted by members of the NHS REC and by our trial statistician.…”

Section: Focus Groups With Health-care Professionalsmentioning

confidence: 99%

The AMBER care bundle for hospital inpatients with uncertain recovery nearing the end of life: the ImproveCare feasibility cluster RCT

Koffman

Yorganci

Murtagh

et al. 2019

Health Technol Assess

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Background Patients admitted to hospital with a terminal illness and uncertain recovery often receive inconsistent care and do not have the opportunity to die in their preferred place of death. Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented. The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle was developed to remedy this. It has not been evaluated in a randomised trial, but a definitive trial would face many hurdles. Objective To optimise the design of and determine the feasibility of a pragmatic, multicentre, cluster randomised controlled trial of the AMBER care bundle compared with best standard care. Design A feasibility cluster randomised controlled trial including semistructured interviews with patients and relatives, focus groups with health-care professionals, non-participant observations of multidisciplinary team meetings, a standard care survey, heat maps and case note reviews. Retrospective data were collected from the family or close friends of deceased patients via a bereavement survey. Setting Four general medical wards at district general hospitals in England. Participants There were 65 participants (control, n = 36; intervention, n = 29). There were 24 interviews, four focus groups, 15 non-participant meeting observations, six case note reviews and three heat maps, and 15 of out 23 bereavement, standard care surveys were completed. Intervention The AMBER care bundle is implemented by a nurse facilitator. It includes the development and documentation of a medical plan, consideration of outcomes, resuscitation and escalation status and daily plan revisiting. The AMBER care bundle encourages staff, patients and families to talk openly about their preferences and priorities should the worst happen. Main outcome measures Two ‘candidate’ primary outcomes were selected to be evaluated for a future definitive trial: Integrated Palliative care Outcome Scale patient/family anxiety and communication subscale and ‘howRwe’. The secondary outcome measures were Integrated Palliative care Outcome Scale symptoms, Australian-modified Karnofsky Performance Status scale, EuroQol-5 Dimensions, five-level version, Client Service Receipt Inventory, recruitment rate, intervention fidelity and intervention acceptability. Results Data were collected for 65 patients. This trial was not powered to measure clinical effectiveness, but variance and changes observed in the Integrated Palliative care Outcome Scale subscale indicated that this measure would probably detect differences within a definitive trial. It was feasible to collect data on health, social and informal care service use and on quality of life at two time points. The AMBER care bundle was broadly acceptable to all stakeholders and was delivered as planned. The emphasis on ‘clinical uncertainty’ prompted health-care professional awareness of often-overlooked patients. Reviewing patients’ AMBER care bundle status was integrated into routine practice. Refinements included simplifying the inclusion criteria and improving health-care professional communication training. Improvements to trial procedures included extending the time devoted to recruitment and simplifying consent procedures. There was also a recommendation to reduce data collected from patients and relatives to minimise burden. Limitations The recruitment rate was lower than anticipated. The inclusion criteria for the trial were difficult to interpret. Information sheets and consent procedures were too detailed and lengthy for the target population. Health-care professionals’ enthusiasm and specialty were not considered while picking trial wards. Participant recruitment took place later during hospital admission and the majority of participants were lost to follow-up because they had been discharged. Those who participated may have different characteristics from those who did not. Conclusions This feasibility trial has demonstrated that an evaluation of the AMBER care bundle among an acutely unwell patient population, although technically possible, is not practical or feasible. The intervention requires optimisation. Trial registration Current Controlled Trials ISRCTN36040085. National Institute for Health Research (NIHR) Portfolio registration number 32682. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 55. See the NIHR Journals Library website for further project information.

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Advance care planning for adults with heart failure

Nishikawa

Hiroyama

Fukahori

et al. 2020

Cochrane Database of Systematic Reviews

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The feasibility of a randomised controlled trial to compare the cost-effectiveness of palliative cardiology or usual care in people with advanced heart failure: Two exploratory prospective cohorts

Cited by 12 publications

References 40 publications

Multi-disciplinary palliative care is effective in people with symptomatic heart failure: A systematic review and narrative synthesis

Multi-disciplinary palliative care is effective in people with symptomatic heart failure: A systematic review and narrative synthesis

The AMBER care bundle for hospital inpatients with uncertain recovery nearing the end of life: the ImproveCare feasibility cluster RCT

Advance care planning for adults with heart failure

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