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

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Abstract

Background:

The effectiveness of cardiology-led palliative care is unknown; we have insufficient information to conduct a full trial.

Aim:

To assess the feasibility (recruitment/retention, data quality, variability/sample size estimation, safety) of a clinical trial of palliative cardiology effectiveness.

Design:

Non-randomised feasibility.

Setting/participants:

Unmatched symptomatic heart failure patients on optimal cardiac treatment from (1) cardiology-led palliative service (caring together group) and (2) heart failure liaison service (usual care group).

Outcomes/safety:

Symptoms (Edmonton Symptom Assessment Scale), Kansas City Cardiomyopathy Questionnaire, performance, understanding of disease, anticipatory care planning, cost-effectiveness, survival and carer burden.

Results:

A total of 77 participants (caring together group = 43; usual care group = 34) were enrolled (53% men; mean age 77 years (33–100)). The caring together group scored worse in Edmonton Symptom Assessment Scale (43.5 vs 35.2) and Kansas City Cardiomyopathy Questionnaire (35.4 vs 39.9). The caring together group had a lower consent/screen ratio (1:1.7 vs 1: 2.8) and few died before approach (0.08% vs 16%) or declined invitation (17% vs 37%).

Data quality:

At 4 months, 74% in the caring together group and 71% in the usual care group provided data. Most attrition was due to death or deterioration. Data quality in self-report measures was otherwise good.

Safety:

There was no difference in survival. Symptoms and quality of life improved in both groups. A future trial requires 141 (202 allowing 30% attrition) to detect a minimal clinical difference (1 point) in Edmonton Symptom Assessment Scale score for breathlessness (80% power). More participants (176; 252 allowing 30% attrition) are needed to detect a 10.5 change in Kansas City Cardiomyopathy Questionnaire score (80% power; minimum clinical difference = 5).

Conclusion:

A trial to test the clinical effectiveness (improvement in breathlessness) of cardiology-led palliative care is feasible.

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Most cited references 29

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The Australia-modified Karnofsky Performance Status (AKPS) scale: a revised scale for contemporary palliative care clinical practice [ISRCTN81117481]

Amy Abernethy, Tania Shelby-James, Belinda S Fazekas … (2005)

Background The Karnofsky Performance Status (KPS) is a gold standard scale. The Thorne-modified KPS (TKPS) focuses on community-based care and has been shown to be more relevant to palliative care settings than the original KPS. The Australia-modified KPS (AKPS) blends KPS and TKPS to accommodate any setting of care. Methods Performance status was measured using all three scales for palliative care patients enrolled in a randomized controlled trial in South Australia. Care occurred in a range of settings. Survival was defined from enrollment to death. Results Ratings were collected at 1600 timepoints for 306 participants. The median score on all scales was 60. KPS and AKPS agreed in 87% of ratings; 79% of disagreements occurred within 1 level on the 11-level scales. KPS and TKPS agreed in 76% of ratings; 85% of disagreements occurred within one level. AKPS and TKPS agreed in 85% of ratings; 87% of disagreements were within one level. Strongest agreement occurred at the highest levels (70–90), with greatest disagreement at lower levels (≤40). Kappa coefficients for agreement were KPS-TKPS 0.71, KPS-AKPS 0.84, and AKPS-TKPS 0.82 (all p < 0.001). Spearman correlations with survival were KPS 0.26, TKPS 0.27 and AKPS 0.26 (all p < 0.001). AKPS was most predictive of survival at the lower range of the scale. All had longitudinal test-retest validity. Face validity was greatest for the AKPS. Conclusion The AKPS is a useful modification of the KPS that is more appropriate for clinical settings that include multiple venues of care such as palliative care.

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Palliative care in heart failure: a position statement from the palliative care workshop of the Heart Failure Association of the European Society of Cardiology.

Piotr Ponikowski, Etienne Delacrétaz, … (2009)

Heart failure is a serious condition and equivalent to malignant disease in terms of symptom burden and mortality. At this moment only a comparatively small number of heart failure patients receive specialist palliative care. Heart failure patients may have generic palliative care needs, such as refractory multifaceted symptoms, communication and decision making issues and the requirement for family support. The Advanced Heart Failure Study Group of the Heart Failure Association of the European Society of Cardiology organized a workshop to address the issue of palliative care in heart failure to increase awareness of the need for palliative care. Additional objectives included improving the accessibility and quality of palliative care for heart failure patients and promoting the development of heart failure-orientated palliative care services across Europe. This document represents a synthesis of the presentations and discussion during the workshop and describes recommendations in the area of delivery of quality care to patients and families, education, treatment coordination, research and policy.

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Effects of person-centred and integrated chronic heart failure and palliative home care. PREFER: a randomized controlled study.

Kurt Boman, Kurt Boman (2014)

We evaluated the outcome of person-centred and integrated Palliative advanced home caRE and heart FailurE caRe (PREFER) with regard to patient symptoms, health-related quality of life (HQRL), and hospitalizations compared with usual care. From January 2011 to October 2012, 36 (26 males, 10 females, mean age 81.9 years) patients with chronic heart failure (NYHA class III-IV) were randomized to PREFER and 36 (25 males, 11 females, mean age 76.6 years) to the control group at a single centre. Prospective assessments were made at 1, 3, and 6 months using the Edmonton Symptom Assessment Scale, Euro Qol, Kansas City Cardiomyopathy Questionnaire, and rehospitalizations. Between-group analysis revealed that patients receiving PREFER had improved HRQL compared with controls (57.6 ± 19.2 vs. 48.5 ± 24.4, age-adjusted P-value = 0.05). Within-group analysis revealed a 26% improvement in the PREFER group for HRQL (P = 0.046) compared with 3% (P = 0.82) in the control group. Nausea was improved in the PREFER group (2.4 ± 2.7 vs. 1.7 ± 1.7, P = 0.02), and total symptom burden, self-efficacy, and quality of life improved by 18% (P = 0.035), 17% (P = 0.041), and 24% (P = 0.047), respectively. NYHA class improved in 11 of the 28 (39%) PREFER patients compared with 3 of the 29 (10%) control patients (P = 0.015). Fifteen rehospitalizations (103 days) occurred in the PREFER group, compared with 53 (305 days) in the control group. Person-centred care combined with active heart failure and palliative care at home has the potential to improve quality of life and morbidity substantially in patients with severe chronic heart failure. NCT01304381. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.

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Author and article information

Journal

Journal ID (nlm-ta): Palliat Med

Journal ID (iso-abbrev): Palliat Med

Journal ID (publisher-id): PMJ

Journal ID (hwp): sppmj

Title: Palliative Medicine

Publisher: SAGE Publications (Sage UK: London, England )

ISSN (Print): 0269-2163

ISSN (Electronic): 1477-030X

Publication date (Electronic): 24 April 2018

Publication date (Print): June 2018

Volume: 32

Issue: 6

Pages: 1133-1141

Affiliations

[1 ]Wolfson Palliative Care Research Centre, Hull York Medical School and University of Hull, Hull, UK

[2 ]Robertson Centre for Biostatistics, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK

[3 ]Health Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK

[4 ]Glasgow Caledonian University, British Heart Foundation, NHS Greater Glasgow and Clyde, Glasgow, UK

[5 ]William R Lindsay Chair of Health Economics (Health Economics and Health Technology Assessment), Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK

[6 ]Glasgow University, Glasgow, UK

Author notes

[*]Miriam J Johnson, Wolfson Palliative Care Research Centre, Hull York Medical School and University of Hull, Allam Medical Building, Hull HU6 7RX, UK. Email: Miriam.johnson@ 123456hyms.ac.uk

Author information

Miriam J Johnson https://orcid.org/0000-0001-6204-9158

Article

Publisher ID: 10.1177_0269216318763225

DOI: 10.1177/0269216318763225

PMC ID: 5967038

PubMed ID: 29688127

SO-VID: 06b0e7d8-ea5c-4768-8c71-078941ff41b9

License:

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

History

Funding

Funded by: British Heart Foundation, FundRef https://doi.org/10.13039/501100000274;

Award ID: commissioned

Funded by: Marie Curie Cancer Care, FundRef https://doi.org/10.13039/501100000654;

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

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Abstract

Background:

Aim:

Design:

Setting/participants:

Outcomes/safety:

Results:

Data quality:

Safety:

Conclusion:

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Cardiovascular Innovations and Applications

Most cited references 29

The Australia-modified Karnofsky Performance Status (AKPS) scale: a revised scale for contemporary palliative care clinical practice [ISRCTN81117481]

Palliative care in heart failure: a position statement from the palliative care workshop of the Heart Failure Association of the European Society of Cardiology.

Effects of person-centred and integrated chronic heart failure and palliative home care. PREFER: a randomized controlled study.

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