Comparative effectiveness and cost analysis of an anticoagulation clinic versus laboratory based practice in Kenyan Tertiary Referral Hospitals

Abstract

Background: The laboratory based practice for monitoring oral anticoagulation therapy is laboratory testing of blood to measure the International Normalized Ratio. This is the current practice at Kenyatta National Hospital. Studies that have been carried out at Kenyatta National Hospital have shown that majority of patients on oral anticoagulation therapy spend most of their time with their International Normalized Ratios out of therapeutic range. Point of care testing devices offer an alternative to laboratory testing. At Moi Teaching and Referral Hospital, patients are monitored using point-of care devices and the warfarin dose adjusted according to protocols. This is done in a specialised anticoagulation clinic that specifically manages anticoagulation therapy. Objectives: The objective of this study was to carry out a comparative effectiveness and cost analysis of specialized anticoagulant clinic at Moi Teaching and Referral Hospital versus current practice at Kenyatta National Hospital for monitoring of coagulation status. Methodology: The study was divided into two sections: comparison of International Normalised Ratio values as a measure of effectiveness and the cost analysis of specialized anticoagulation clinic versus laboratory based practice. A comparative retrospective longitudinal study was carried out to compare the quality of anticoagulation therapy for the two modes of service delivery. The study was conducted at the hemato-oncology and cardiothoracic clinics of Kenyatta National Hospital and the anticoagulant clinic of Moi Teaching and Referral Hospital. The study population was all patients on oral anticoagulation therapy seen at the clinics from January 2015 to April 2017. The patients were included in the study if they; were above 18 years, required an oral anticoagulant for more than one month and had at least two International Normalised Ratio values. Universal sampling was carried out and the calculated sample size was 120 patient files. Data was collected with the aid of a predesigned structured data collection form designed by Karuri (2016). For the cost analysis, a micro ingredient costing approach was used to examine all resources incurred in provision of the service. Health care provider perspective was considered. Key informant interviews were conducted to obtain costs. The key informants were selected by purposeful sampling and the inclusion criteria was: worked at the clinics for a period of at least 6 months, had managerial positions and provided informed consent. Data analysis was performed using STATA version 13 and R version 3.3.2 software. Socio demographic and clinical characteristics were summarized into percentages for categorical data and continuous data into means and standard deviation. Costs were summarised as cost per month and estimates of the

financial consequences of adopting a pharmacist led anticoagulation clinic was determined. Sensitivity analysis was carried out to determine the variables which greatly affected each intervention. Results: Above 75% of the patients from both institutions were females. The most prevalent indication for anticoagulation use at both institutions was deep venous thrombosis. The most prevalent comorbidity in both instituitions was HIV. According to survival curves obtained from survival analysis, coagulation therapy in Kenyatta National Hospital was suboptimal compared to Moi Teaching and Referral Hospital and therefore there was better International Normalised Ratio control at the specialised anticoagulation clinic. According to the findings, there was a higher probability of patients being at hypercoagulability state in KNH compared to those in MTRH. Therapeutic INR was attained at a faster rate in MTRH compared to KNH and more patients in KNH were at a greater bleeding risk than those at MTRH.Total cost per month for monitoring International Normalised Ratio at Kenyatta National Hospital was Ksh1343762. Total cost per month for monitoring International Normalised Ratio at Moi Teaching and Referral Hospital was Ksh 1177696. The cost at Moi Teaching and Referral Hospital was slightly lower than the cost at Kenyatta National Hospital. The most sensitive variable that greatly affected the cost ratio was the fraction of time the healthcare workers spent in the Kenyatta National Hospital clinics. Approximately Ksh 5.8 million was required to start an anticoagulation clinic. Conclusion: From the findings, the total cost per month at the anticoagulation clinic of Moi Teaching and Referral Hospital was lower and more effective than the laboratory based practice at Kenyatta National Hospital. The anticoagulation clinic had various advantages compared to the laboratory based practice. It is therefore recommended that Kenyatta National Hospital to consider implementing an anticoagulation clinic in order to improve monitoring of anticoagulation therapy