Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia.
Cost consequence analysis
Low income country
Palliative care
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
19
12
2019
revised:
20
03
2020
accepted:
28
03
2020
entrez:
21
4
2020
pubmed:
21
4
2020
medline:
21
4
2020
Statut:
epublish
Résumé
Patient-reported outcomes and economic aspects of Palliative Care (PC) provision in low-income countries (LIC) are under-studied. Demonstrating the economic value of PC is key to sustainability and guiding health care policy. Our preliminary data in Ethiopia demonstrated a widespread need for PC, poor access to it, and high out of pocket payments (OOP). We suspect that in this and other LIC, PC may function not only to reduce suffering but also as a poverty reduction strategy.We are conducting a randomized controlled trial of standard Oncology care versus standard Oncology care plus PC in newly diagnosed cancer patients in Addis Ababa. Ninety-seven adults presenting to Oncology Clinic will be randomized in a 1:1 ratio. Subjects receiving PC will meet with a PC provider at time of enrollment and at follow up visits in their homes. All subjects will be assessed via questionnaire at enrollment and follow-up Oncology visits at 8 ± 4 and 12 ± 4 weeks. A cost-consequence analysis will be performed, to include: patient-reported OOP and healthcare utilization, the latter to be assessed through chart adjudication. Outcomes will include change in African Palliative Care Association Palliative Outcome Score, changes in OOP and healthcare utilization.We hypothesize that the cost of home-based PC will be offset by improvements in patient-reported outcomes, decreased OOP and healthcare utilization, rendering PC cost-effective in this LIC. These findings may lead to widespread dissemination of an effective, sustainable and cost-saving public PC delivery strategy that would improve the quality of life and death for millions of people. Clinicaltrials.gov NCT03712436.
Identifiants
pubmed: 32309673
doi: 10.1016/j.conctc.2020.100564
pii: S2451-8654(20)30048-X
pii: 100564
pmc: PMC7154993
doi:
Banques de données
ClinicalTrials.gov
['NCT03712436']
Types de publication
Journal Article
Langues
eng
Pagination
100564Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
Informations de copyright
© 2020 The Authors.
Déclaration de conflit d'intérêts
All authors declare that they have no conflict of interest.
Références
Value Health. 2015 Mar;18(2):161-72
pubmed: 25773551
Health Qual Life Outcomes. 2010 Jan 25;8:10
pubmed: 20100332
PLoS Med. 2014 Sep 22;11(9):e1001731
pubmed: 25243899
BMJ Glob Health. 2017 Feb 14;2(1):e000139
pubmed: 28588999
Health Aff (Millwood). 2013 Mar;32(3):552-61
pubmed: 23459735
PLoS One. 2011;6(6):e20821
pubmed: 21695127
BMJ Support Palliat Care. 2019 Jun;9(2):120-129
pubmed: 30274970
PLoS One. 2018 Feb 15;13(2):e0193018
pubmed: 29447258
Palliat Med. 2014 Feb;28(2):130-50
pubmed: 23838378
Lancet. 2003 Jul 12;362(9378):111-7
pubmed: 12867110
JAMA Intern Med. 2018 Jun 1;178(6):820-829
pubmed: 29710177
Lancet. 2016 Oct 8;388(10053):1603-1658
pubmed: 27733283
Value Health. 2005 Jan-Feb;8(1):67-79
pubmed: 15841896
Bull World Health Organ. 2012 Sep 1;90(9):664-71
pubmed: 22984311
J Palliat Med. 2018 May;21(5):622-630
pubmed: 29425055
J Pain Symptom Manage. 2004 Sep;28(3):200-10
pubmed: 15336332
Lancet. 2018 Apr 7;391(10128):1391-1454
pubmed: 29032993
JAMA. 2014 Nov 12;312(18):1888-96
pubmed: 25387186
JAMA. 2008 Apr 9;299(14):1698-709
pubmed: 18398082
J Palliat Med. 2001 Winter;4(4):465-74
pubmed: 11798478
J Pain Symptom Manage. 2009 Jul;38(1):32-44
pubmed: 19615625
Support Care Cancer. 2016 May;24(5):2075-2084
pubmed: 26546456
J Health Econ. 2000 Sep;19(5):679-95
pubmed: 11184799
Value Health. 2005 Sep-Oct;8(5):521-33
pubmed: 16176491