Hellen Kariuki

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

BackgroundPatients 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/designThis 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.DiscussionThe 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

Nurse-led palliative care for HIV-positive patients taking antiretroviral therapy in Kenya: a randomised controlled trial

BACKGROUND People with HIV accessing antiretroviral therapy (ART) have persistent physical, psychological, social, and spiritual problems, which are associated with poor quality of life and treatment outcomes. We assessed the effectiveness of a nurse-led palliative care intervention on patient-reported outcomes. METHODS We did this randomised controlled trial at a clinic in Kenya for adults with HIV, established on ART, and reporting moderate-to-severe pain or symptoms. We randomly assigned participants (1:1) either to a palliative care intervention (including assessments of physical, emotional, and spiritual wellbeing and quality of life) given six times over 4 months, or to usual care. Participants and investigators were not masked to allocation. The primary outcome was pain (scored on the African Palliative Care Associations African Palliative Outcome Scale). This trial is registered with ClinicalTrials.gov, number NCT01608802. FINDINGS We screened 2070 patients, of whom we enrolled 120: 60 allocated to each group. In the control group, median pain score improved from 1·0 (IQR 0·0-2·0) at baseline to 5·0 (3·0-5·0) at 4 months; in the intervention group, it improved from 1·0 (0·0-2·0) at baseline to 4·5 (3·0-5·0) at 4 months. Compared with standard care, the intervention had no significant effect on pain (coefficient -0·01, 95% CI -0·36 to 0·34, p=0·95). INTERPRETATION A nurse-led palliative care intervention was not effective in reducing pain. However, person-centred assessment and care delivered by staff who have received additional training had positive effects on self-reported mental health related quality of life and psychosocial wellbeing. FUNDING Diana Princess of Wales Memorial Fund.

Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya

ABSTRACT Experimental studies to test interventions for people living with HIV in low- and middle-income countries are essential to ensure appropriate and effective clinical care. The implications of study participation on outcome data in such populations have been discussed theoretically, but rarely empirically examined. We aimed to explore the effects of participating in a randomised controlled trial conducted in an HIV clinic in Mombasa, Kenya. We report qualitative data from the Treatment Outcomes in Palliative Care trial, which evaluated the impact of a nurse-led palliative care intervention for HIV positive adults on antiretroviral therapy compared to standard care. Participants in both arms attended five monthly quantitative data collection appointments. Post-trial exit, 10 control and 20 intervention patients participated in semi-structured qualitative interviews, analysed using thematic analysis. We found benefit attributed to the compassion of the research team, social support, communication, completion of patient reported outcome measures (PROMs) and material support (transport reimbursement). Being treated with compassion and receiving social support enabled participants to build positive relationships with the research team, which improved mental health and well-being. Open and non-judgmental communication made participants feel accepted. Participants described how repeated completion of the PROMs was a prompt for reflection, through which they began to help themselves and self-care. Participant reimbursements relieved financial hardship and enabled them to fulfil their social responsibilities, enhancing self-worth. These findings emphasise the importance of compassion, support and effective communication in the clinical encounter, particularly in stigmatised and isolated populations, and the potential of the integration of simple PROMs to improve patient outcomes. Participation in research has unexpected positive benefits for participants, which should be taken into account when designing research in similar populations. Researchers should be aware of the effects of financial reimbursement and contact with researchers in isolated and impoverished communities.

A pilot study investigating the effect of a patient-held pain assessment tool in palliative care outpatients attending a rural Kenyan hospital

Background: Pain is a frequent and distressing symptom in palliative care patients worldwide. Careful assessment is the first vital step to relieve this suffering. Assessment tools form a useful adjunct to pain management, but whether they make a difference to the patient is not known. Aim: The objective of this study was to investigate whether the use of a patient-held pain assessment tool can make a difference in patient’s pain control. Setting and Participants: AIC Kijabe Hospital, Kenya, has had a nurse-led Palliative Care Service since 2002, with an annual case-load of around 600 patients. Study participants were recruited from among adult palliative care patients attending the Outpatient Department. Design: A quantitative experimental study methodology was employed. In the pre-intervention phase, pain was assessed at study entry and at 2 weeks, following ‘standard’ care at home; 49 patients were recruited for this phase. In the intervention phase, pain assessments were made at entry, with follow-up assessment after introduction to a patient-held pain assessment tool taken home by each patient; 50 patients were recruited for this phase. Analysis involved a comparison of baseline and 2-week pain scores between the two groups. Results: The results demonstrated that the use of a patient-held pain assessment tool led to an increase in the number of patients reaching satisfactory pain relief, from 30% in the pre-intervention group, to 69% in the intervention group. Conclusion: This study has demonstrated that a simple pain assessment tool, when linked to some action, may help achieve better analgesia.

Antinocieptive and anti-inflammatory effects of Toddalia asiatica (L) Lam. (Rutaceae) root extract in Swiss albino mice.

Introduction Toddalia asiatica is a commonly used medicinal plant in East Africa for the management of pain and inflammatory conditions. The present study investigated the antinociceptive and the anti-inflammatory effects of T. asiatica in Swiss albino mice. Methods The antinociceptive and the anti-inflammatory effects of T. asiatica were investigated using formalin-induced pain test and the carrageenin-induced oedema paw. The extract solvent (vehicle), aspirin and indomethacin were employed as negative and positive controls respectively. Eight mice were used in each experiment. Results In the early phase of the formalin test, the 100mg/kg dose showed no significant antinociceptive activity while the 200mg/kg showed significant (p < 0.01) antinociceptive activity. The 100 mg/kg dose showed highly significant antinociceptive activity (p < 0.001) in the late phase of the formalin test while the 200mg/kg dose showed no significant antinociceptive activity. A reduction in carragenin induced acute inflammation paw oedema was significant (p < 0.01) following administration of 100mg/kg dose but not with the 200mg/kg dose. Conclusion The present study therefore lends support to the anecdotal evidence for use of T. asiatica in the management of painful and inflammatory conditions.

Effect of participation in a randomised controlled trial of an integrated palliative care intervention on HIV-associated stigma.

ABSTRACT We conducted in Kenya a mixed-methods randomised controlled trial (RCT) of a nurse-led palliative care intervention integrated with anti-retroviral therapy (ART) provision for the management of HIV. Here we report qualitative findings showing increased resistance to HIV-associated stigma among trial participants. A mixed method design was chosen to enable identification of the active ingredients of the intervention and exploration of participants’ experiences of receiving the intervention. The RCT was conducted from July 2011 to November 2012 in a community hospital in the city of Mombasa, Kenya, with a sample of 120 adults with HIV on ART. Thirty participants were purposively selected to take part in a qualitative exit interview, based on study arm and mental health outcome. Inductive thematic analysis revealed increased resistance to HIV-associated stigma in both the intervention and control groups. Specifically, patients in both groups described benefit from the social support, compassionate care, and open and respectful communication they received through study participation. Participants described improved self-image, increased access to social agency, and increased resistance to HIV-associated stigma. Our findings suggest that there is potential to increase resistance to stigma through simple mechanisms of support, compassion, and improved communication in routine care. The self-reported impact of trial participation on stigma also has implications for future trials in populations in resource-constrained settings where stigma is common.