Treatment outcomes in palliative care: the TOPCare study. A mixed methods phase III randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy

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dc.contributor.authorLowther, Keiraen_ZA
dc.contributor.authorSimms, Victoriaen_ZA
dc.contributor.authorSelman, Lucyen_ZA
dc.contributor.authorSherr, Lorraineen_ZA
dc.contributor.authorGwyther, Lizen_ZA
dc.contributor.authorKariuki, Hellenen_ZA
dc.contributor.authorAhmed, Aabiden_ZA
dc.contributor.authorAli, Zipporahen_ZA
dc.contributor.authorJenkins, Rachelen_ZA
dc.contributor.authorHigginson, Ireneen_ZA
dc.contributor.authorHarding, Richarden_ZA
dc.date.accessioned2015-11-18T04:02:39Z
dc.date.available2015-11-18T04:02:39Z
dc.date.issued2012en_ZA
dc.description.abstractBACKGROUND: Patients with HIV/AIDS on Antiretroviral Therapy (ART) suffer from physical, psychological and spiritual problems. Despite international policy explicitly stating that a multidimensional approach such as palliative care should be delivered throughout the disease trajectory and alongside treatment, the effectiveness of this approach has not been tested in ART-experienced populations.METHODS/DESIGN:This mixed methods study uses a Randomised Controlled Trial (RCT) to test the null hypothesis that receipt of palliative care in addition to standard HIV care does not affect pain compared to standard care alone. An additional qualitative component will explore the mechanism of action and participant experience. The sample size is designed to detect a statistically significant decrease in reported pain, determined by a two tailed test and a p value of [less than or equal to]0.05. Recruited patients will be adults on ART for more than one month, who report significant pain or symptoms which have lasted for more than two weeks (as measured by the African Palliative Care Association (APCA) African Palliative Outcome Scale (POS)). The intervention under trial is palliative care delivered by an existing HIV facility nurse trained to a set standard. Following an initial pilot the study will be delivered in two African countries, using two parallel independent Phase III clinical RCTs. Qualitative data will be collected from semi structured interviews and documentation from clinical encounters, to explore the experience of receiving palliative care in this context.DISCUSSION:The data provided by this study will provide evidence to inform the improvement of outcomes for people living with HIV and on ART in Africa.ClinicalTrials.gov Identifier: NCT01608802en_ZA
dc.identifier.apacitationLowther, K., Simms, V., Selman, L., Sherr, L., Gwyther, L., Kariuki, H., ... Harding, R. (2012). Treatment outcomes in palliative care: the TOPCare study. A mixed methods phase III randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy. <i>BMC Infectious Diseases</i>, http://hdl.handle.net/11427/15101en_ZA
dc.identifier.chicagocitationLowther, Keira, Victoria Simms, Lucy Selman, Lorraine Sherr, Liz Gwyther, Hellen Kariuki, Aabid Ahmed, et al "Treatment outcomes in palliative care: the TOPCare study. A mixed methods phase III randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy." <i>BMC Infectious Diseases</i> (2012) http://hdl.handle.net/11427/15101en_ZA
dc.identifier.citationLowther, K., Simms, V., Selman, L., Sherr, L., Gwyther, L., Kariuki, H., ... & Harding, R. (2012). Treatment outcomes in palliative care: the TOPCare study. A mixed methods phase III randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy. BMC infectious diseases, 12(1), 288.en_ZA
dc.identifier.ris TY - Journal Article AU - Lowther, Keira AU - Simms, Victoria AU - Selman, Lucy AU - Sherr, Lorraine AU - Gwyther, Liz AU - Kariuki, Hellen AU - Ahmed, Aabid AU - Ali, Zipporah AU - Jenkins, Rachel AU - Higginson, Irene AU - Harding, Richard AB - BACKGROUND: Patients with HIV/AIDS on Antiretroviral Therapy (ART) suffer from physical, psychological and spiritual problems. Despite international policy explicitly stating that a multidimensional approach such as palliative care should be delivered throughout the disease trajectory and alongside treatment, the effectiveness of this approach has not been tested in ART-experienced populations.METHODS/DESIGN:This mixed methods study uses a Randomised Controlled Trial (RCT) to test the null hypothesis that receipt of palliative care in addition to standard HIV care does not affect pain compared to standard care alone. An additional qualitative component will explore the mechanism of action and participant experience. The sample size is designed to detect a statistically significant decrease in reported pain, determined by a two tailed test and a p value of [less than or equal to]0.05. Recruited patients will be adults on ART for more than one month, who report significant pain or symptoms which have lasted for more than two weeks (as measured by the African Palliative Care Association (APCA) African Palliative Outcome Scale (POS)). The intervention under trial is palliative care delivered by an existing HIV facility nurse trained to a set standard. Following an initial pilot the study will be delivered in two African countries, using two parallel independent Phase III clinical RCTs. Qualitative data will be collected from semi structured interviews and documentation from clinical encounters, to explore the experience of receiving palliative care in this context.DISCUSSION:The data provided by this study will provide evidence to inform the improvement of outcomes for people living with HIV and on ART in Africa.ClinicalTrials.gov Identifier: NCT01608802 DA - 2012 DB - OpenUCT DO - 10.1186/1471-2334-12-288 DP - University of Cape Town J1 - BMC Infectious Diseases LK - https://open.uct.ac.za PB - University of Cape Town PY - 2012 T1 - Treatment outcomes in palliative care: the TOPCare study. A mixed methods phase III randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy TI - Treatment outcomes in palliative care: the TOPCare study. A mixed methods phase III randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy UR - http://hdl.handle.net/11427/15101 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/15101
dc.identifier.urihttp://dx.doi.org/10.1186/1471-2334-12-288
dc.identifier.vancouvercitationLowther K, Simms V, Selman L, Sherr L, Gwyther L, Kariuki H, et al. Treatment outcomes in palliative care: the TOPCare study. A mixed methods phase III randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy. BMC Infectious Diseases. 2012; http://hdl.handle.net/11427/15101.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDepartment of Public Health and Family Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2012 Lowther et al.; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceBMC Infectious Diseasesen_ZA
dc.source.urihttp://www.biomedcentral.com/bmcinfectdis/en_ZA
dc.subject.otherHIV/AIDSen_ZA
dc.subject.otherAntiretroviral Therapy (ART)en_ZA
dc.subject.otherpalliative careen_ZA
dc.titleTreatment outcomes in palliative care: the TOPCare study. A mixed methods phase III randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapyen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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