Received: September 05, 2011 / Accepted: September 29, 2011 / Published: December 25, 2011.

Transcription

1 Computer Technology and Application 2 (2011) Testing Point of Care Portable Data Capture in a Hospital HIV Transmission Prevention Programme and Experience from Computerized Patient Management in a Sub-Saharan Clinic Setting Michael Kavuma 1 and Maurice Mars 2 1. Management Sciences for Health, Plot 15, Princess Anne Drive Bugolobi, P.O Box 71419, Kampala, Uganda 2. Department of Tele-Health, Nelson R Mandela Medical School, University of KwaZulu Natal, 719 Umbilo Road 4001, Durban, Private Bag 7 Congella 4013, South Africa Received: September 05, 2011 / Accepted: September 29, 2011 / Published: December 25, Abstract: Clinicians involved in HIV/AIDS (Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome) prevention of mother to child transmission (PMTCT) programme and research activities can benefit from the advantages that computerized systems add to medical practice even in resource constrained sub-saharan clinic settings. Their continued use of paper based systems presents clinical data management and patient care challenges. A portable point of care data capture electronic system and a computerized clinic patient management system (CCPMS) were implemented to remedy these challenges. PMTCT report compilation was easier with the portable data collection system whose data were found to be more complete and accurate with a 0.83% error rate compared to a 4.1% error rate in the paper registers. A resounding majority of clinicians preferred using the new CCPMS with many of the view that it improved drug inventory and general clinic management with a positive effect on patient care. Key words: Testing, portable, computerized, HIV/AIDS (human immunodeficiency virus/acquired immune deficiency syndrome), care, systems. 1. Introduction The human immunodeficiency virus (HIV) which causes acquired immune deficiency syndrome (AIDS) is one of mankind s most devastating epidemics with 6800 persons becoming infected with the disease everyday and 5700 persons dying from the disease daily. Sub-Saharan Africa continues to be the region most affected by HIV/AIDS with more than 2 out of 3 adults and nearly 90% of children infected with HIV living in the region and illustrating the unmet need for HIV transmission interventions there [1]. Approximately 2 million people are living with HIV in Uganda with Corresponding author: Michael Kavuma, B.Sc., MMedSci, research field: medical informatics. mikavs@gmail.com. more women infected with the virus compared to men (six women to every five men) [2]. Mother to child transmission is the 2nd major mode of transmission of HIV in the country. It is the number one mode of transmission of HIV to children with over 95% of the infected children contracting the virus this way. Efforts in Uganda to prevent the spread of HIV from infected mothers to their vulnerable new born babies have shown significant success through research activities and national scale up programmes in HIV/AIDS prevention of mother to child transmission (PMTCT). Ground breaking PMTCT research was completed at the Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration at Mulago Hospital complex in Kampala, Uganda with

2 1016 Testing Point of Care Portable Data Capture in a Hospital HIV Transmission Prevention Programme overwhelming results showing that administration of an intrapartum dose of nevirapine to expectant HIV positive mothers followed by a dose of nevirapine to their neonates within 72 hours of birth reduced vertical transmission of HIV/AIDS to the child by at least 50% [3]. The Ministry of Health in Uganda with support from development partners initiated a national scale up programme based on these research findings to provide a comprehensive PMTCT package to pregnant mothers in order to reduce the risk of transmission of HIV to their neonates. However, clinicians and investigators involved in HIV/AIDS PMTCT programme and research activities at Mulago Hospital, the country s main referral and busiest hospital, continue to face challenges in their work. An elaborate paper based programme data management system provides data inconsistencies and inaccurate programme statistics due to data management flaws caused by transcription errors, dispersed information and minimal data validation checks. Periodic hospital PMTCT reports are always delayed due to the acute effort required in their preparation. PMTCT data also show that 8.6% of women enrolled into the programme at Mulago Hospital do not take their mother to child transmission (MTCT) prophylaxis medication at labour due to process and logistics challenges which defeats the purpose of the intervention efforts. Continuing research at the MU-JHU research unit at Mulago Hospital complex also presents heavy daily patient loads with paper based patient management proving to be an administrative burden. Efficient management of the clinic and drug inventory at the research unit is lacking in the unit s entirely paper based environment. Medical informatics involves the integration of computational and communication technologies into medical practice to improve diagnostic, prognostic and therapeutic outcomes for improved patient care and health service delivery. Various systems approaches are being proposed in this regard with computer based physician order entry and decision support systems identified as key elements of technology implementations to improve patient safety and reduce medical errors [4]. Computerized medical record systems have been deployed in rural HIV programs and health facilities to assist in clinical data management and support patient care [5], and also to improve clinic process efficiency and enhance clinic visit outcomes [6]. Computerized health data collection systems have been shown to significantly reduce errors and to provide quality clinical data [7], with order entry using hand held computers also used to streamline and simplify clinical data capture [8]. Tablet computers have been found to be suitable for documenting point of care patient information [9], with computerized systems also shown to improve patient satisfaction with care at the point of patient-physician interaction [10]. Electronic health record systems can improve time efficiency for nursing staff in clinic workflow processes [11], and are useful in patient tracking and minimizing loss to follow up in chronic management of HIV/AIDS and tuberculosis [12]. There is also an increasing appreciation for computerized clinical note capture tools by clinicians to enhance patient care documentation efficiency [13]. A portable point of care data capture electronic system was deployed to remedy the data management challenges of the PMTCT programme at Mulago Hospital and a computerized clinic patient management system (CCPMS) was implemented at the MU-JHU Research unit also at Mulago Hospital to improve patient and drug inventory management and enhance clinicians work flow efficiency. The two computerized systems were implemented and evaluated against existing paper based systems in an effort to improve data management in the hospital s PMTCT programme while reducing the number of reported HIV positive mothers missing their MTCT prophylaxis dosing and to improve patient load handling, quality of patient care and drug inventory management at the research unit s clinic.

3 Testing Point of Care Portable Data Capture in a Hospital HIV Transmission Prevention Programme 1017 The first section of this paper describes the challenges of paper based systems in HIV care and research in Uganda and sections 2 and 3 describe the approach and results from implementing computerized systems in HIV programme and research activities there. Sections 4 and 5 discuss the results and experience from implementing the computerized systems while sections 6 and 7 include the authors contributions and acknowledgements. 2. Methods 2.1 Requirements Specification and System Design Health care information systems must incorporate clinical workflow analysis as a key feature for the determination and specification of system requirements involving a full factual assessment of the required inputs, outputs and processes [14]. The hospital s PMTCT programme involved client enrolment in the antenatal clinic, dosing in the labour wards and follow up in the post natal clinic with paper based registers used to manage all these programme processes. The use of paper registers presented operational challenges in the programme with the need for a portable computerized solution to minimize these deficiencies as clinicians made the rounds through the mentioned programme areas. The HIV/AIDS research clinic had check-in and check-out nursing stations, physicians consultation stations, a research pharmacy and external laboratory services from a nearby accredited laboratory. The clinic run a paper based system that included patient registration and visit tracking, physician consultation and patient management as well as pharmacy management which incorporated patient dispensing. The paper based system was identified to have some inefficiency in all these areas and the computerized system design included specifications to remedy these inefficiencies. The research clinic required networked computerized workstations at the check-in, check-out and pharmacy areas running a multi-user tiered application on a shared backend database. An integrated Microsoft Access and Visual Basic PMTCT data collection application was designed and deployed on HP TC4200 tablet computers for point of care portable data capture in the hospital by PMTCT clinicians. Another integrated Microsoft Access and Visual Basic clinic patient management application was designed for the HIV/AIDS research clinic and deployed on Windows networked desktops at the afore mentioned clinic stations. A relational database structure was adopted to create entity relationships between data tables in both integrated database applications [15] with the classic model of systems development through requirements analysis, specification, design, implementation, testing, debugging and maintenance followed [16] in each application s deployment. 2.2 Sampling and Data Collection The point of care portable tablet personal computer (PC) data capture system was tested and evaluated against the existing hospital PMTCT paper based system for a twelve weeks period. Both the existing PMTCT paper based registers and the computerized tablet PC system were used in parallel to collect individually non identifying PMTCT client data. Screening, enrolment, delivery and follow up data collected using the tablet PCs and wirelessly synchronized through encrypted connections to a central server were compared with those collected using the paper based registers at the end of the testing period. Both data sets were analyzed for accuracy, completeness, integrity, ease of collection, speed of generation of predefined reports and missed MTCT prophylaxis doses. Using a 95% level of significance, baseline proportion rates for the paper registers and tablet PC system were computed and the required sample size of records needed for collection in each system was calculated as: n = ((P1 (100 - P1) + P2 (100 P2)) / (P2- P1) 2 ) f(α, β), where f(α, β) is a function of α and β derived from statistical tables and P1 and P2 are baseline proportion rates for each system to be

4 1018 Testing Point of Care Portable Data Capture in a Hospital HIV Transmission Prevention Programme evaluated [17]. A sample size of n = 424 was obtained as the required number of records to be collected in each of the hospital data collection systems, i.e., paper registers and tablet PC system. To evaluate the computerized clinic patient management system designed for the HIV/AIDS research unit, a quantitative evaluation questionnaire was administered to 31 of the 35 clinic staff that used both the CCPMS and existing paper based system to assess their satisfaction with the ability of the CCPMS to improve clinic management, drug inventory management and patient care. Respondents included 26 research nurses, two nursing managers and three pharmacists. After extensive training of clinic staff on the new system, it was used in parallel with the existing paper based system also for twelve weeks with the questionnaire administered to users at the end of this period. 2.3 Data Analysis and Limitations Statistical analysis using SAS 9.1 software on the hospital tablet PC and manual entry data sets generated from Microsoft Access databases used in data collection looked at relevant frequency figures on variables of interest as well as trends and proportion rates in the data sets to determine their cumulative closeness to the desired end state. Fisher s exact test was used to compare categorical data between nominal variables [18] in the two data sets. For the CCPMS, frequencies of staff responses were analysed to determine whether staff perceptions indicated that the computerized clinic patient management system performed to its intended proportions. The open ended questions and general advantages and disadvantages were analysed for recurrent themes also in this respect. The tablet PC point of care data capture system was limited to collection of PMTCT programme data and did not include other hospital patient information. The CCPMS was limited to use by nurses and pharmacists and did not entirely cover the aspect of improvement of quality of care received by patients attending the research clinic since doctors who were the primary care providers were not key system users. 3. Results Generation of programme related reports was a core requirement for Mulago Hospital s PMTCT programme to provide continuous updates on the programme s progress to hospital managers, programme staff and the Ministry of Health. The tablet PC portable system was required to improve the programme s data management efforts and ease generation of reports which included information on new antenatal clinic (ANC) clients, number that had been pre-test counselled, number accepting voluntary counselling and testing, number of HIV positive clients, number of post-test counselled clients, number of clients receiving the full PMTCT package, total deliveries, client infant feeding options, etc. Report generation from the PMTCT paper based system was observed to be a reasonably complex and time consuming process involving initial data capture, transcription into registers, data entry into a database system, editing, cleaning, validation and report generation. It took an average of three days to complete the mentioned tasks and compile a detailed report for a single day s activities. In contrast, detailed reports for the day from the tablet PC system could be generated the same day their pre-requisite data had been captured requiring minimal cleaning and validation due to data entry checks and alerts embedded into the system. It was observed to be significantly easier to generate reports from the portable informatics system than from the existing paper based system. Tablet PC system data were observed to be more complete compared to paper based system data. For the 424 records in the paper based registers data set, 22 records, (5%), were found to be incomplete while significantly fewer, 3 (0.7%) out of the 424 records from the tablet PC system data set, were found to be incomplete, p < , Fisher s exact test.

5 Testing Point of Care Portable Data Capture in a Hospital HIV Transmission Prevention Programme 1019 Error rates in data collection were also observed to be significantly less in the tablet PC system compared to the paper based system. For the twelve days of project data collection in the hospital, a total of 10 errors was found in the tablet PC data set (average = 0.83 errors daily). A significantly higher number of errors, 49, were found in the data set collected using the existing hospital paper based PMTCT programme registers (average = 4.1 errors daily), p < , Fisher s exact test (Fig. 1). For minimization of potentially missed infant and maternal MTCT prophylaxis dosing, missed maternal dosages in the paper based system data set were reported at 7%, (3 out of 42 enrolled women). The tablet PC data set reported 5%, (2 out of 43 enrolled women). Reported missed infant dosages in the paper based system data set were 14% (4 babies out of 27 babies delivered to enrolled mothers) and in the tablet PC data set, 4%, were reported (1 baby out of 25 records of babies delivered to enrolled mothers). Though statistics on missed MTCT intervention dosing in both systems did not include consideration that maternal gestation periods could have been outside the project implementation period, a slightly higher number of missed dosages for both infants and mothers was observed in the paper based system data compared to data from the tablet PCs. The questionnaire evaluation of the computerized clinic patient management system designed for the MU-JHU research unit asked respondents their choice of system for use the in HIV/AIDS research unit s clinic. Preference was between the existing paper based system and the deployed CCPMS. 90% (28) of the respondents preferred using the CCPMS over the clinic s paper based system while 6% (2) preferred the paper based system and 4% (1) had no preference. 68% of the clinicians (21 respondents) thought the CCPMS had a small positive impact on the quality of care for patients attending the clinic. They cited generation of clinic procedure and lab test alerts at patient visits, advance notification of required drug regimens for in clinic patients, drug expiry notifications, prohibiting dispensing of expired drug batches, recording drug regimen adherence and capturing of patient visit and drug dispensing history as relevant information to support patient care. Some clinicians, 26% (8 respondents), thought the computerized system worsened inventory management and drug dispensing stating that the system was in some instances rigid in its use which increased work complexity for clinicians. However, the majority of clinicians, 48% (15 respondents), thought the computerized system significantly improved drug inventory management and dispensing commenting that it improved accuracy and reliability in monitoring the drug inventory and reporting on patient dispenses (Fig. 2). The majority of clinicians, 55% (17 respondents) thought the computerized clinic system significantly improved efficiency in patient load handling with 52% (16 respondents), of the view that the system provided up to 80% accuracy in reporting clinic attendance figures while only 6% (2 respondents) thought the CCPMS was wrong in its reporting of daily patient attendance figures. 4. Discussion Fig. 1 Error trends between paper based hospital registers and tablet PC portable system. The Mulago Hospital PMTCT programme experienced process and logistics challenges with an

6 1020 Testing Point of Care Portable Data Capture in a Hospital HIV Transmission Prevention Programme Fig. 2 Clinicians opinion of the effect of the CCPMS on drug inventory management and dispensing. elaborate paper based register system which provided room for data management flaws and complicated periodic hospital PMTCT report generation. Statistics also showed that some enrolled clients were missing their MTCT prophylaxis dosing. A point of care portable data capture system deployed on tablet PCs was tested in the hospital to remedy these challenges. The tablet PC dataset was observed to be significantly more accurate than the paper based data set due to extensive data validation rules in the entry screens of the computerized system. Also PMTCT clinicians received real time flags and alerts on programme data management and client dosing while using the portable system which helped minimize errors. Because data collected electronically were synchronized with the main database through a secure connection in a timely fashion, the integrity of the data was not compromised unlike in the paper register data set which had some information omitted or changed during multiple transcription steps. Programme reports were observed to be faster and easier to generate with the tablet PC solution which had its data immediately usable once captured by clinicians. An analysis between the paper register and tablet PC data sets revealed an insignificant number of missed dosages for mothers in both systems but a significant number of missed dosages for babies in the paper register data set. Automated clinician reminders of expected enrolments, deliveries and follow up of programme clients in the tablet PC system might have contributed to a reduction in the tablet PC data set though some assumptions taken such as client gestational periods, availability of programme drugs and accurate reporting on dosing might warrant further investigation for a conclusive deduction. The MU-JHU research clinic experienced challenges in clinic management with heavy daily patient loads proving to be an administrative burden and efficient drug inventory management lacking. A computerized clinic patient management system was designed to address the problems of patient numbers and drug management in the research clinic. The resounding majority of clinicians preferred using the computerized clinic patient management system over the existing paper based clinic system with many of the view that it positively impacted on the quality of patient care by generating checklists of patient procedures based on study protocols, required drug refills, dispensing alerts, check-in and check-out flags and other useful earlier mentioned patient management functionality. Most thought the new CCPMS significantly improved drug inventory management and dispensing in the research clinic and eased auditing of the pharmacy since dispenses could be linked to patients and dispensing staff. It provided real time information on drug stocks, expiries, patient regimens, drug billing information and a wealth of other information that was not readily available through the paper based system. The majority of clinicians thought the CCPMS improved the efficiency of patient load handling and eased the work of management of the clinic. In support of this, some mentioned that because the CCPMS provided daily figures of expected clients which were generated through pre-defined scheduling algorithms, real time views of patient queues at various clinic

7 Testing Point of Care Portable Data Capture in a Hospital HIV Transmission Prevention Programme 1021 stations and required drugs and procedures, improved planning was possible for clinic patients. Optimal staffing and logistics could be prearranged which enhanced the administrative efforts of the clinic and improved its general day to day running. The CCPMS thus provided clinic management with timely information to support logistical planning to cater for the clinic s heavy patient load. 5. Conclusions Computational technologies and medical informatics solutions could advance the work of medical practitioners and researchers involved in the prevention of mother to child transmission of HIV/AIDS in Uganda if well incorporated into their job function. The tablet PC informatics application developed for mobile wireless data capture in the hospital PMTCT programme brings to light the fact that seemingly complex technologies can be adopted in resource constrained health care settings to achieve more efficient medical data management and reporting at reasonable cost with visible results. Its successful use for portable data collection in a busy HIV/AIDS prevention of mother to child transmission programme in a national referral hospital leading to a reduction in reported missed MTCT prophylaxis dosing, improved accuracy in data collection and enhanced data management makes integration of portable clinician point of care order entry into mainstream medical practice increasingly necessary because of evident benefits to care providers and patients alike. And though not currently in use in the hospital partly due to the lack of basic supporting information technology infrastructure, it highlights the possibilities for improved point of care capture of patient information to enhance care outcomes in resource constrained settings using affordable new technologies. Sustained use of the tablet PC data collection system could have been gained through development of the required infrastructure to support continued use of the system and use of a thinner, lighter and more portable tablet PC model. The successful deployment of a computerized clinic patient management system (CCPMS) in a very busy clinical setting with strict documentation requirements provides useful demonstration of how computerized systems can successfully replace existing paper based systems to consolidate medical practice efforts in places where technology advancement is still in its infancy. The attitudes of clinicians using the CCPMS developed for the MU-JHU research unit highlights the willingness of clinicians and health care providers to adopt these systems for their everyday use to improve work outputs and enhance patient care outcomes evident by the continued use of the system at the research unit even after the project period. Wider acceptance of the CCPMS could have been gained by ensuring that the system was completely bug free at deployment, more flexible in its operation and there was continuous training of users on the system. 6. Authors Contributions Michael Kavuma was the principal investigator for the project and contributed most of the writing for this manuscript. As the principal investigator, he designed, developed and deployed both computerized applications and coordinated the implementation and evaluation of both systems. Professor Maurice Mars supervised the entire project from beginning to end and contributed the writing for various parts of this manuscript. He oversaw the design and implementation of the project and provided medical and statistical input in measurement and validation of the project results. Acknowledgments This paper is based on an earlier paper by the same authors titled The Design, Implementation and Evaluation of Computerized Clinic Patient Management and Clinician Order Entry Systems in a

8 1022 Testing Point of Care Portable Data Capture in a Hospital HIV Transmission Prevention Programme PMTCT Clinic in Uganda from the IST-Africa 2011 conference proceedings published in the IEEE Xplore digital library. We acknowledge the assistance of the Makerere University-Johns Hopkins University Research Collaboration unit s senior management, clinic staff and pharmacy staff during implementation and evaluation of the computerized clinic patient management system. We also acknowledge the assistance of Mulago hospital s Department of Obstetrics and Gynaecology and PMTCT programme staff during implementation and evaluation of the hospital tablet PC portable data capture system. We acknowledge the assistance of Assistant Professor Hamish S.F Fraser for the initial concept of the research and general guidance on the implementation of the project. We also acknowledge the assistance of Mr. Michael Mubiru for the valuable statistical input during the project s design and evaluation phases and Mr. Adrian Taylor for his guidance in the coding and deployment of the computerized applications. References [1] Joint United Nations Programme on HIV/AIDS, AIDS Epidemic Update 2007, available online at: e_en.pdf, accessed: May 14, [2] Uganda Bureau of Statistics 2006, Uganda Demographic and Health Survey 2006, available online at: uments/uganda%20dhs%202006%20final%20%20rep ort.pdf, accessed: October 19, [3] L. Guay, P. Musoke, F. Mmiro, B. Jackson, C. Nakabitto, et al., Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial, The Lancet 354, (9181) (1999) [4] E.S. Berner, Clinical Decision Support Systems: Theory and Practice, 2nd ed., Health Informatics Series, Springer, New York, [5] H. Fraser, D. Jazayeri, P. Nevil, Y. Karacaoglu, P. Farmer, E. Lyon, M. Fawzi, M. Leandre, S. Choi, J. Mukherjee, An information system and medical record to support HIV treatment in rural Haiti, British Medical Journal 329 (7475) (2004) [6] J. Rotich, T. Hannan, F. Smith, J. Bii, W. Odero, N. Vu, B. Mamlin, J. Mamlin, J. Einterz, W. Tierney, Installing and implementing a computer based patient record system in sub-saharan Africa: The mosoriot medical record system, Journal of the American Medical Informatics Association, 10 (4) (2003) [7] D. Foster, B. Snow, Using microcomputers for rapid data collection in developing countries, Oxford Journal 7 (1) (1992) [8] M. Missinou, C. Olola, S. Issifou, P. Matsiegui, A. Adegnika, A. Borrmann, D. Wypij, T. Taylor, P. Kremsner, Piloting paperless data entry for clinical research in Africa, American Journal of Tropical Medicine and Hygiene 72 (3) (2005) [9] G. Silvey, J. Macri, P. Lee, D. Lobach, Direct comparison of a tablet computer and a personal digital assistant for point-of-care documentation in eye care, in: Proceedings of American Medical Informatics Association Annual Symposium, 2005, pp , available online at: accessed: February 10, [10] J. Hsu, J. Huang, V. Fung, N. Robertson, H. Jimison, R. Frankel, Health information technology and physician-patient interactions: Impact of computers on communication during outpatient primary care visits, Journal of the American Medical Informatics Association 12 (4) (2005) [11] L. Poissant, J. PereiraR. Tamblyn, Y. Kawasumi, The impact of electronic health records on time efficiency of physcians and nurses: A systematic review, Journal of the American Medical Informatics Association 12 (5) (2005) [12] H. Fraser, C. Allen, C. Bailey, G. Douglas, S. Shin, J. Blaya, Information systems for patient follow-up and chronic management of HIV and tuberculosis: A life-saving technology in resource-poor areas, Journal of Medical Internet Research 9 (4) (2007) e29. [13] S.T. Rosenbloom, J. Grande, A. Geissbuhler, R.A. Miller, Experience in implementing inpatient clinical note capture via a provider order entry system, Journal of the American Medical Informatics Association 11 (10) (2004) [14] M. Conrick, Health Informatics: Transforming Healthcare with Technology, Nelson Thornes, London, [15] P. Rob, C. Coronel, Database Systems: Design, Implementation and Management, 5th ed., Course Technology, Massachusetts, [16] E. Shortliffe, L. Perrault, G. Wiederhold, L. Fagan, Medical Informatics: Computer Applications in Health Care and Biomedicine, 2nd ed., Springer-Verlag, New York, [17] S. Pocock, Clinical Trials: A Practical Approach, John Wiley and Sons, New York, [18] H. McDonald, Handbook of Biological Statistics, 2009, available online at: html, accessed: February 23, 2010.