AN EDUCATIONAL INTERVENTION TO REDUCE PAIN AND IMPROVE PAIN RELATED OUTCOMES FOR MALAWIAN PEOPLE LIVING WITH HIV/AIDS AND THEIR FAMILY CARERS: A RANDOMISED CONTROLLED TRIAL Kennedy NkhomA MSc; BSc. R.N Thesis submitted to the University of NottinghAm for the degree of Doctor of Philosophy September 2015 Abstract Background: Many HIV/AIDS patients experience pain. This is often associated with advanced HIV/AIDS infection and side effects of treatment. In sub-Saharan Africa, pain management for people with HIV/AIDS is suboptimal. With survival extended as a direct consequence of improved access to antiretroviral therapy, the prevalence of HIV/AIDS related pain is increasing. As most care is provided at home, the management of pain requires patient and family involvement. Pain education is an important aspect in the management of pain in HIV/AIDS patients. Aim: The aim of this study was to evaluate the effects of a pain educational intervention on pain severity and pain related outcomes among patients with HIV/AIDS and their family carers. Methods: Two systematic reviews were conducted: (1) to examine the evidence base of the effectiveness of educational interventions delivered to people living with HIV/AIDS on pain severity, pain interference, quality of life, knowledge of pain management, and (2) To examine the evidence base of the effectiveness of educational interventions delivered to their family carers on knowledge of pain management, quality of life and carer motivation. A randomised controlled trial was conducted at the HIV and palliative care clinics of two public hospitals in Malawi. To be eligible, patient participants had a diagnosis of HIV/AIDS (stage III or IV). Carer participants were individuals most involved in the patient’s unpaid care. Eligible participants were randomised to either: (1) a 30- minute face–to-face educational intervention covering pain assessment and management, augmented by a leaflet and follow-up telephone call at two weeks; or (2) usual care. Those allocated to the usual care group receive the educational intervention after follow-up assessments had been conducted (wait-list control group). The primary outcome was average pain severity measured by the Brief Pain Inventory. Secondary outcomes were pain interference, patient knowledge of pain i management, patient quality of life. Carer outcomes were; carer knowledge of pain management, caregiver motivation and carer quality of life. Follow-up assessments were conducted eight weeks after randomisation by nurses’ blind to allocation. Results: Systematic review Eight published randomised controlled trials of educational interventions among patients with HIV/AIDS were identified. Only one study examined the effect on pain severity but the results were not statistically significant. Three studies reported positive effects in improving severity and frequency of symptoms, three reported improvement in quality of life and two studies found improvement in knowledge. Seven published studies of family carers of HIV/AIDS patients were identified. Only three of which were randomised controlled trials. Five of these reported that educational interventions were effective in reducing psychosocial outcomes. Two studies reported that the interventions improved knowledge outcomes among family carers of HIV/AIDS patients. Trial Of the 182 patients/carers dyads randomised; 167 patients and 157 carers completed the trial. At follow-up, patients in the intervention group experienced a greater decrease in average pain severity score 21.25 (mean difference 21.25, 95% confidence interval 16.7 to 25.8; P <0.001). Patients in the intervention group reported, less pain interference (mean difference 24.5, 95% confidence interval 19.61 to 29.38; P<0.001), had improved knowledge of pain management (mean difference 20.39, 95% confidence interval 17.51 to 23.27; P<0.001), and a better quality of life (mean difference 28.76, 95% confidence interval 24.62 to 32.91; P<0.001). At follow-up carers in the intervention group had improved Knowledge (mean difference 20.32, 95% confidence interval 17.37 to 23.28; P<0.001), greater motivation (mean difference 7.64, 95% confidence interval 5.15 to 10.13; P<0.001) and better quality of life (mean difference 34.16, 95% confidence interval 30.15 to 38.17; P<0.001). Conclusion: Current evidence of educational interventions among HIV/AIDS and family carers on pain severity is inconclusive and based on a relatively small number of studies, many of which have methodological problems. ii A relatively simple form of pain education is effective in reducing pain and improving outcomes for patients with HIV/AIDS and their carers. Greater attention needs to be given to incorporating this into the routine care of people with HIV/AIDS in sub- Saharan Africa. Trial registration: Current Controlled Trials ISRCTN72861423 iii List of outputs Nkhoma K, Seymour J, Arthur A. 2015. An educational intervention to reduce pain and improve pain management for Malawian people living with HIV/AIDS and their family carers: a randomised controlled trial. In press doi:10.1016/j.jpainsymman.2015.01.011. (Appendix 15). Nkhoma, K., Seymour, J. & Arthur, A. 2013. An educational intervention to reduce pain and improve pain management for Malawian people living with HIV/AIDS and their family carers: study protocol for a randomised controlled trial. Trials, 14, 216. (Appendix 15). Nkhoma, K. 2014. An educational intervention to reduce pain and improve pain management for Malawian people living with HIV/AIDS and their family carers: a randomised controlled trial Lawrence S. Bloomberg Faculty of Nursing Emerging Scholars Forum October 20-21, 2014 Toronto, Canada. iv Acknowledgements I give thanks to heavenly father for the protection and care throughout my PhD journey; I have had spiritual challenges, but my God has always been there. I would liKe to thank my supervisors Professor Antony Arthur and Professor Jane Seymour for their constructive criticism throughout the PhD journey. I had no idea how to go about designing the study, but through their support and guidance I was able to conduct a trial, analyse data, publish some work, and attract funding for both short cources and conferences. I have learned a lot from them. I would liKe to thank all the patients and family carers who were involved in designing the information leaflet, including all health care workers who were involved in designing the leaftlet. Special thanks should go to all patients and family carers who took part in the study, their response and enthusiasm add a lot of strength to this study. They made the process of recruitment very interesting. Many thanks to Amin and Oscar for conducting follow-up outcomes. All staff members at Ekwendeni and Mzuzu central hospital deserve a mention as well for their support in recruitment of patients and any form of support rendered to me during the field work. I would also like to acknowledge the financial support provided by the University of Nottingham, School of Health Sciences (tuition fees) and the Malawi Government for my upKeep allowances without which it would have been impossible to undertake this research. You made my PhD journey a bit easier because I did not have to worry about finances. I wish to thank Esther my lovely wife for her love, motivation and support during the PhD journey including all my family members; my parents, brothers and sisters for their spiritual support and guidance including prayers. Finally all my friends in B33 (PhD office) for moral support, academic support including social support, and all my friends in different parts of the world. v TABLE OF CONTENTS Abstract .............................................................................................................. i List of outputs ................................................................................................... iv Acknowledgements ............................................................................................ v List of tables ................................................................................................... xiii List of figures ................................................................................................... xv List of Abbreviations ...................................................................................... xvii CHAPTER ONE: INTRODUCTION AND OVERVIEW ............................................... 1 1.1 Aim of the stuDy ................................................................................................................................... 1 1.2 Objectives of the stuDy ...................................................................................................................... 1 1.3 Significance of the stuDy ................................................................................................................... 2 1.4 Conventions anD terminology useD in the thesis ..................................................................... 5 1.5 structure of the thesis ........................................................................................................................ 7 CHAPTER TWO: CONTEXTUAL INTRODUCTION AND BACKGROUND .................... 9 2.1 BackgrounD ............................................................................................................................................. 9 2.2 Health care services in Malawi ...................................................................................................... 18 2.3 Socio-economic