Outcomes for Antiretroviral Therapy Patients Receiving Palliative Care (TOPCare)
Despite overwhelming need for effective HIV palliative care in sub-Saharan Africa, a systematic appraisal of the literature found almost no outcome or evaluative evidence.
The investigators aim to evaluate the efficacy of HIV palliative care training and a simple palliative care assessment tool provided to nurses of patients on Antiretroviral Therapy (ART), and to evaluate this in terms of patient outcomes under clinical experimental conditions in 2 African countries using randomised controlled trial (RCT) designs.
Intervention being tested:
Within each well-established HIV ART clinic, patients will be randomly allocated to either continue receiving standard care (control group) or to receive standard care plus appointments with a clinic nurse trained in basic palliative care (intervention group). The intervention nurse will receive weekly supervision from a local palliative care service and will use a simple assessment form at each patient appointment.
Design: Each Phase III clinical trial (i.e. one trial in each of 2 countries) will be powered and conducted in parallel to a common research design protocol, thus permitting evidence of outcomes that reflects 2 different ART providers, providing evidence of palliative care efficacy relevant to different HIV care settings. Each of the 2 HIV care facilities (one in each of Kenya and South Africa) is a highly experienced HIV and ART care provider, with proven longevity. The providers of the palliative care training are longstanding experts in the delivery of both palliative care training and palliative care.
Primary outcome: Each trial has been powered to a primary endpoint of pain control.
Secondary outcomes: The secondary outcomes are the core domains of palliative care as defined by the WHO (i.e. physical, including symptoms, psychological, social and spiritual) and measured by the APCA African POS. Further secondary outcomes measured will be: adherence to treatment; risk behaviours; health-related quality of life; and an additional measure of psychological morbidity.
The primary and secondary outcomes are the same for each country's trial.
This study aims to reject the null hypothesis that receipt of palliative care in addition to standard care does not affect pain compared to those receiving standard care alone.
Inclusion: Patients will be screened and invited into the trial if they are on ART, score 3-5 on the 0-5 APCA African POS pain or symptom items, are 18 years or older, and can give informed consent to trial entry and data collection.
Analysis: An intention-to-treat analysis will be conducted to determine treatment response differences between the two conditions. In order to maximise the efficiency of longitudinal data, multi-level modelling will be applied as appropriate.
The investigators have selected an randomized controlled trial (RCT) design, with multiple country partners, in order that outputs have maximum potential influence.
The revised CONSORT trial statement for non-drug trials has been applied to ensure potential publication in the leading 400 medical journals.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase 3 Trial of Palliative Care for HIV Patients on Antiretroviral Therapy|
- Self-report pain using the APCA African POS [ Time Frame: Period of 4 months ] [ Designated as safety issue: No ]Our primary outcome is the pain item of the African Palliative Care Association Palliative care Outcome Scale
- Psychological morbidity [ Time Frame: Period of 4 months ] [ Designated as safety issue: No ]Psychological Morbidity using the GHQ
- Quality of Life [ Time Frame: 4 month period ] [ Designated as safety issue: No ]Quality of Life using the MOS-HIV
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Standard care
Standard care will be provided to the control group, i.e. existing HIV outpatient multiprofessional care, ART monitoring and adherence support.
Other: Standard care
Patients attend monthly for their ART monitoring and prescription filling, and a multiprofessional team is available as necessary.
Experimental: Palliative care
Palliative care delivered by an existing nurse who has been provided with palliative care training, palliative care patient management planning records, and clinical supervision
Other: Palliative care
Regular appointments with an existing clinic nurse who has been trained in palliative care, the patient is asked about their physical, psychological, social and spiritual problems, and a care management plan devised with referral as necessary.
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|Contact: Richard Harding, PhDemail@example.com|
|Contact: Lucy Bradley, BScfirstname.lastname@example.org|
|BOMU Hospital||Active, not recruiting|
|Ivan Toms Clinic||Recruiting|
|Cape Town, Western Cape, South Africa|
|Contact: Paul Nkurunziza|
|Principal Investigator: Liz Gwyther, MSc|
|Principal Investigator:||Richard Harding, PhD||King's College London|