Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia
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, po...
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| Format: | Article |
| Language: | English |
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Elsevier
2020-06-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S245186542030048X |
| _version_ | 1818302553188728832 |
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| author | Eleanor Reid Ephrem Abathun Jilcha Diribi Yoseph Mamo Peter Hall Marie Fallon Tigineh Wondemagegnhu Liz Grant |
| author_facet | Eleanor Reid Ephrem Abathun Jilcha Diribi Yoseph Mamo Peter Hall Marie Fallon Tigineh Wondemagegnhu Liz Grant |
| author_sort | Eleanor Reid |
| collection | DOAJ |
| description | 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. Trial registration: Clinicaltrials.gov NCT03712436. |
| first_indexed | 2024-12-13T05:40:44Z |
| format | Article |
| id | doaj.art-2ccf21c433ec4f2b9c8c189248e72ba4 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-13T05:40:44Z |
| publishDate | 2020-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-2ccf21c433ec4f2b9c8c189248e72ba42022-12-21T23:57:47ZengElsevierContemporary Clinical Trials Communications2451-86542020-06-0118100564Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, EthiopiaEleanor Reid0Ephrem Abathun1Jilcha Diribi2Yoseph Mamo3Peter Hall4Marie Fallon5Tigineh Wondemagegnhu6Liz Grant7Yale University School of Medicine, New Haven, USA; University of Edinburgh Global Health Academy, Edinburgh, UK; Corresponding author. Yale University School of Medicine, 464 Congress, Ave, Suite 260, New Haven, CT, 06519, USA.Hospice Ethiopia, Addis Ababa, EthiopiaAddis Ababa University College of Health Sciences, Addis Ababa, EthiopiaHospice Ethiopia, Addis Ababa, EthiopiaCancer Research UK Edinburgh Centre, University of Edinburgh, Edinburgh, UKCancer Research UK Edinburgh Centre, University of Edinburgh, Edinburgh, UKAddis Ababa University College of Health Sciences, Addis Ababa, EthiopiaUniversity of Edinburgh Global Health Academy, Edinburgh, UKPatient-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. Trial registration: Clinicaltrials.gov NCT03712436.http://www.sciencedirect.com/science/article/pii/S245186542030048XPalliative careCost consequence analysisLow income country |
| spellingShingle | Eleanor Reid Ephrem Abathun Jilcha Diribi Yoseph Mamo Peter Hall Marie Fallon Tigineh Wondemagegnhu Liz Grant Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia Contemporary Clinical Trials Communications Palliative care Cost consequence analysis Low income country |
| title | Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia |
| title_full | Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia |
| title_fullStr | Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia |
| title_full_unstemmed | Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia |
| title_short | Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia |
| title_sort | rationale and study design a randomized controlled trial of early palliative care in newly diagnosed cancer patients in addis ababa ethiopia |
| topic | Palliative care Cost consequence analysis Low income country |
| url | http://www.sciencedirect.com/science/article/pii/S245186542030048X |
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