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

TY - JOUR

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

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 J

AU - Harding, Richard

PY - 2012/11/6

Y1 - 2012/11/6

N2 - 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 <= 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.

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 <= 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.

KW - Young Adult

KW - Humans

KW - Nurses

KW - Aged

KW - Palliative Care

KW - Anti-Retroviral Agents

KW - Aged, 80 and over

KW - Biomedical Research

KW - HIV Infections

KW - Adult

KW - Treatment Outcome

KW - Middle Aged

KW - Adolescent

KW - Female

KW - Male

U2 - 10.1186/1471-2334-12-288

DO - 10.1186/1471-2334-12-288

M3 - Article

C2 - 23130740

SN - 1471-2334

VL - 12

SP - -

JO - BMC infectious diseases

JF - BMC infectious diseases

M1 - 288

ER -