An information system to manage the rollout of the antiretroviral treatment programme in the Free State

Curationis 33 (2): 60-68 The Acquired Immune Deficiency Syndrome epidemic, caused by the Human Immu­ nodeficiency Virus, is a global crisis which threatens development gains, economies, and societies. Within sub-Saharan Africa, where the epidemic began the earliest and the HIV prevalence is the highest, African countries have death rates not seen be­ fore. In South Africa the epidemic has a devastating impact which creates profound suffering on individuals and their families, and the impact on the socio-economic level is of great concern. The eradication of HIV/AIDS represents one of humanity’s greatest challenges, which requires co-operation and comprehensive collaboration between many different role players. In this endeavour clinical information plays a major role. To combat the effect of the disease, the Free State Department of Health started with the provisioning of antiretroviral therapy in the public health sector. The objective of this paper was to address the challenges they faced in order to develop and imple­ ment an information system to manage the rollout of antiretroviral treatment effec­ tively. They started with a paper-based system to collect vital information. It was followed by a palm computer project that was initiated to electronically capture the data collected by the paper-based system. This system was then replaced by a comprehensive Hospital and Clinic Information System which was acquired and customised for the antiretroviral data collection process. Research partners devel­ oped a standalone antiretroviral data warehouse for collecting information associ­ ated with the monitoring and evaluation of the Free State antiretroviral and HIV/ AIDS treatment programme. The data warehouse successfully produced several management information reports to the antiretroviral management team. A need was identified to design a comprehensive antiretroviral data warehouse that will integrate „ data from several operational sources which are all associated with HIV/AIDS. Informatics University of the Free State RO. Box 339 Bloemfontein 9300 Tel: (051)401-2297 Fax:(051)401-2297 E-mail: theo@ufs.ac.za


Introduction
The Acquired Immune Deficiency Syn drome (AIDS) epidemic, caused by the Human Immunodeficiency Virus (HIV), is a global crisis which threatens de velopment gains, economies, and so cieties.The epidemic has evolved in different ways in various parts o f the world, and at varying speeds.In many regions it is still in its early stages.AIDS is unique in human history in its rapid spread, its extent and the depth o f its impact.In its yearly Global Report on AIDS, the United Nations reported that in the 20 years of the disease's exist ence, almost 20 million people already died and 33 million people (range: 30.3 -36.1 million) worldwide are living with HIV (UNAIDS, 2008c:32).
Within sub-Saharan Africa, where the epidemic began the earliest and the HIV prevalence is the highest, African coun tries have death rates not experienced since the 1950'so r 1960's.According to UN AIDS (2008a:5), sub-Saharan Af rica remains the most heavily affected by HIV, accounting for 67% of all peo ple living with HIV and for 72% of AIDS deaths in 2007.The UNAIDS Global Report estimated that the number of AIDS related deaths in South Africa in 2007 ranged anywhere between 270 000 and 420 000 (UNAIDS, 2008b:217).
In South Africa the epidemic has a dev astating impact which creates profound suffering on individuals and their fami lies, and the impact on the socio-economic level is o f great concern.HIV/ AIDS is a major threat to the most pro ductive segment of the labour force and contributes to reduced earnings, im posing huge costs on enterprises in all sectors through decreasing productiv ity, increasing labour costs, and loss of skills and experience.HIV/AIDS is affecting fundamental rights at work, with respect to workers and people liv ing with and affected by HIV/AIDS.The epidemic and its impact strike hard est at vulnerable groups including women and children, therefore increas ing existing gender inequalities and exacerbating the problem o f child la bour (UNAIDS, 2004:62).
The HIV/AIDS epidemic threatens the viability o f health-care systems.Treat ing AIDS and related opportunistic in fections are placing heavy burdens on the health-care system of South Africa and throughout the world.The eradi cation o f HIV/AIDS represents one of humanity's greatest challenges, which requires co-operation, and comprehen sive collaboration between science, governments, social institutions, the media, the professions, and the gen eral public.In this endeavour informa tion plays a major role.
In response to this epidemic the South African Government created the HIV/ AIDS and Sexually Transmitted Disease (STD) Strategic Plan.The purpose of the plan is to provide a broad national framework around four priority areas: prevention; treatment, care and sup port; research, monitoring and evalua tion; human and legal rights.In Novem ber 2003,, the South African govern ment adopted the Operational Plan for Comprehensive HIV and AIDS Treat ment and Care, which included the pro vision o f antiretroviral (ARV) therapy in the public health sector (Tshabalala-Msimang, 2003).
The objective o f this paper was to solve the challenges that faced the Free State Department o f Health (FSDOH) in order to obtain management infor mation on the rollout o f the ARV treat ment programme in the Free State.The research methodology that was applied will be provided in the next section.That will be followed by a background on the ARV model o f care framework used.Next the paper-based solution that was adopted to collect vital infor mation will be discussed.A short over view will be provided on a palm-pilot project which was initiated to electroni cally capture data collected by the pa per-based solution.The final part will cover the implementation o f a clinic in formation system to manage the rollout o f the antiretroviral treatment pro gramme.

Research methodology
The research methodology used by this study was action research.Butler, Fel ler, Pope, Murphy & Emerson (2006) noted that in action research projects, researchers collaborate with practition ers to solve practical problems while expanding scien tific know ledge.Baskerville (1999) characterizes infor mation system action research as an increased understanding o f an imme diate social situation, with emphasis on the complex and multivariate nature of this social setting in the information systems (IS) domain.It simultaneously assists in practical problem solving and expands scientific knowledge.
The action research d escrip tio n (Susman & Evered, 1978) details a five phases, cyclical process.The approach first requires the establishment o f a client-system infrastructure or research environment.Then, five identifiable phases are iterated: 1) diagnosing, (2) action planning, (3) action taking, (4) evaluating and (5) specifying learning.Baskerville (1999) provides an explana tion o f these components.The clientsystem infrastructure is the specifica tion and agreement that constitutes the research environment and provides the conditions under which action and change may be specified.The client will be the FSDOH and the researcher will be the author o f this paper.The re search environment will be the Free State Province and will include staff working for the FSDOH at different lev els of management.
Diagnosing corresponds to the identi fication o f the primary problems that are causing the organization's desire for change.Action planning is the col laborative effort o f the researcher and the client to identify organizational ac tions to relieve or improve the speci fied problems.Acting taking then im plements the planned action in a col laborative manner between the re searcher and the client.A collaborative evaluation o f the implemented plan is done to determine if the changes had the desired outcome.Specifying learn ing is formally undertaken last, but is usually an ongoing activity.Baskerville (1999) emphasizes the point that action research produces highly relevant research results, because it is grounded in practical action, aimed at solving an immediate problem while carefully informing theory.
The sections o f the rest o f the paper correspond to the five phases o f the action research approach.The Back ground section corresponds to the di agnosis phase.The ARV Information System section corresponds to the ac tion planning and action taking phase and the Discussion section to the The doctor confirms whether the pa tient must go on ARV treatment.The patients are then referred back to the clinic for drug readiness training which usually lasts 3 weeks.On completion, they return to the hospital-based doc tor for clinical review and initiation of treatment.Follow-up is primarily based at the clinic and nurses are responsible for 4 weekly distribution of medication dispensed by the hospital pharmacy, all blood monitoring (although results are reviewed by the doctor) and moni toring of adherence.Baseline assess ment and 6 monthly follow-up assess ments take place at the hospital by doc tors who also issue prescriptions for ARV drugs.

ARV Information System
The ARV Information System evolved through several phases: a paper-based system, Palm hand-held computers, Hospital Information System, Clinic Information System and Data Ware house.Each o f these phases will now be discussed.

Paper-based system
The foundation of the ARV data col lection process in the Free State was firstly built around the establishment o f a formal paper-based information collection process.This was done to assist the users with three fundamen    (Fairall, Botha, Bateman, Dong, et al., 2004:2).In many instances it is still the sole means o f collecting data and com piling reports.For example in Malawi their AVR programme is monitored and evaluated by means o f an ARV master patient card and an ARV patient regis ter kept for each patient in the clinic (Lowrance, Filler, Makombe, Harries, et al., 2007:378).The FSDOH supported the continued use of the paper-based system, given that it would be risky to impose an alternative system (like di rect electronic capture) on doctors and nurses dealing with the clinical aspects o f a new and complex treatment pro gramme.In Kenya a system was devel oped that transported the completed forms to a central site where data were electronically captured (Siika, Rotich, Simiyu, Kigotho, et al., 2005:347).For the FSDOH it was proposed that the paper-based collection o f data be com bined with early capture into an elec tronic system, preferably at the source (decentralized mobile data capture) where the data capturer is able to vali date responses with the clinician who completed the form.This "editing" process had to be implemented right from the start o f the programme to en sure that nurses and doctors under stand how to complete the forms, and to encourage complete and accurate collection o f data from the outset.
The following paragraphs will explain the contents and usage of each form:

Voluntary Counselling and Testing (Screen and Stage) Form
This form covers voluntary counsel ling and testing and CD4 staging.Pa tients may attend a clinic where volun tary counselling and testing (VCT) but not CD4 staging is offered.In this event the nurse could use the form as a referral to another clinic where CD4 staging is available.The form can also serve as a referral to the doctor at the local ARV treatment hospital.Referral criteria make provision for the referral of patients with CD4 counts > 200 with an AIDS-defming illness or on current or previous treatment.

ARV: Hospital Baseline Assessment Form
This is the most detailed form and cap tures all the factors that may play a role in predicting treatment outcome.These factors include previous exposure to ARV, baseline CD4 and World Health Organization stage.

Drug Readiness Training Form
This form captures information on the three training sessions the patient at tended at the assessment site.

ARV: Clinic Follow-up Visit Form
This form is designed to be completed once a month when patients return to receive treatment.It documents weight, current m edication and screens for drug-related side effects and intoler ance.It also retains a strong focus on the early detection o f tuberculosis.

ARV: Hospital Follow-up Visit Form
This form is completed by a doctor at routine hospital follow-up visits.Ini tially these are planned at 3 month in tervals, but frequency is likely to de crease as patients stabilize on treat ment.The form makes provision for changes in opportunistic infection prophylaxis and ARV treatment.

Referral: Clinic to Hospital Form
Standardized and tailored referral forms could play a vital role in ensuring good co-ordination o f care between clinic and hospital.This form makes provi sion for 5 common reasons for referral to a secondary level, and prompts the primary care clinician to provide infor mation needed for appropriate clinical decision-making at hospital level.

Referral: Hospital to Clinic Form
This is a mirror version of the clinic to hospital referral form.
The different forms and the flow o f the forms are shown in Figure 1.

Hospital Information System
According to the National Health In • patient billing Another key requirement is that the HIS should also be modular and that it should be completely developed and proven.
T he features and functionalities required in the NHC/MIS system vary from hospital to hospital, and certainly vary from one PHC cen tre to another, depending on its size and scope of service.Hence the Appli cations Software o f the NHC/M IS should be modular and flexible so that only relevant modules are implemented in each hospital and PHC centre (NHIS/ SA, 2006:1)."Complete" means that the NHC/MIS should support the func tional requirements as listed by NHIS/ SA (2006:1)."Proven" means that the system, in its entirety, is demonstrably operational in an existing environment and the NHC/HIS must not include any costs for 'applications development' or 'modifications' (NHIS/SA, 2006:1).
Simultaneously, a distributed Patient Database must be created and linked, via the Wide Area Network (WAN) to all the hospitals and Primary Health Care centres to both contribute to and use the database.The HIS should en able any o f its features to be organised around a central database and must support different levels o f access ena bling restricted views of the centralised database.
The FSDOH honoured these require ments when it implemented a HIS at three of its larger hospitals in 1996.The implementation was expanded between 2004 and 2006 with the inclusion of two more regional hospitals.All the hospi tals using the HIS were feeding data into a central Patient Database, which in turn provided the ability to compile a minimum patient record.Taking the existing infrastructure into account, a decision was taken by the FSDOH top management team, that the Clinic In formation System (CIS) to be used for all ARV clinics must be fully developed and linked with the existing HIS.

Clinic Information System
In the previous section it was high lighted that one o f the key require ments o f a Hospital Information Sys tem is to provide all the hospitals and PHC centres the functionality to con tribute and use the central patient da tabase.Furthermore, according to the NHIS/SA document (NHIS/SA, 2006:1), for any Hospital Information System to be developed, installed and initiated in the major public hospitals, an appro priately scaled-down version o f the same Hospital Information System must be implemented in all the smaller hos pitals and PHC centres.It was there fore imperative for the FSDOH that the existing Hospital Information System (Meditech) already used in its three major hospitals, be scaled down and implemented as the electronic system for all the ARV PHC centres.For this paper, this system will hence be referred to as a Clinic Information System.

Meditech
While the paper-based information system was in use and data being cap tured by the interim Palm Pilot system, the acquisition and customization proc ess for the Meditech software com menced.The initial investment of R2.5 million into the software licenses was justified by the fact that for sustain able long-term ARV monitoring and evaluation, the availability of electronic data available for analysis was pivotal.

Medical Research Council Data Warehouse
Whereas an operational database pro vides information on the day-to-day transactions, a data warehouse pro vides strategic information on histori cal data.The MRC in collaboration with the University o f Cape Town (UCT) Lung Institute developed a standalone ARV data warehouse for collecting information associated with the monitoring and evaluation of the Free State ARV and HIV and AIDS Treatment Programme starting in No vember 2004.The data warehouse schema was based on the data received from the Palm Pilot handheld comput ers that were used at the Free State ARV assessment and treatment sites.The data was uploaded via modem to a stag ing database situated at the MRC and then loaded into the ARV data ware house.Although the data warehouse produced several managerial reports to the FSDOH ARV management team, its use was discontinued due to poor data quality which was associated with the Palm Pilot system.The Palm Pilot sys tem was discontinued and replaced with the Meditech Hospital Information system which was implemented at ARV assessment and treatment sites.The existing data warehouse schema was adopted to accommodate the new op erational data source database struc ture by the MRC in January 2006.A model o f how this whole process func tioned is shown in Figure 2.
By the end o f2006 the standalone data warehouse was handed over to the FSDOH to be incorporated into a pro posed FSDOH data warehouse.The end product was to be a single "appro priately designed" ARV data ware house made available for analysis to the relevant FSDOH managers in volved with the ARV treatment pro gramme.

Discussion
The customization and implementation process o f the Meditech MPM soft ware was not without a number of chal lenges.All o f the challenges were iden tified at internal monthly management meetings where the customization and implementation o f the NHC/HIS were discussed as a standing agenda point.Each of the listed challenges were care fully analyzed and solutions were pro posed and implemented.One o f the first challenges faced was during the cu sto m izatio n phase.Meditech South Africa had to develop customer-defined screens (CDS) to ac commodate the already developed pa per-based forms.With this came the notion of building an effective dataflow mechanism which follows the paperbased system in place, but also adhere to best-practice software engineering principles such as user friendliness, screen-to-screen serialization and en suring data integrity and the avoidance of data duplication.This challenge took almost six months and led to the initial delay in the implementation o f the Meditech software.A win-win solution was, however, proposed to accommo date the paper-based system in place, building on the user's familiarity with the complex ARV forms and data col lection processes, and at the same time incorporating HIS functionality.The second challenge was the issue of data quality.Because o f the initial de ployment o f paper-based forms to both assessment and treatment sites in the province, numerous data elements o f a patient were duplicated at each of the ARV PHC sites.With the implementa tion o f the CIS, these duplicate data elements were identified as the data from the paper-forms was being cap tured into the system.For example, the same patient visited three different sites, resulting in three different patient files and three different patient num bers.Subsequently, as each site cap tured the backlog, the same patient was captured three times into the master patient index, each institution unaware of the other's action.The only viable solution was to merge these records on a weekly basis and to systematically remove the inconsistencies within the system.Users were also taught to make use o f the master index lookup before creating a new electronic patient record.Another concept introduced to im prove data quality was to implement the Meditech software in the entire dis trict at the same time.This included the treatment sites and the referring as sessment sites.With this method in place, all users were trained in the same week and also went live the same day.This also cultivated a culture o f more efficient communication among the users in the same district.The third challenge was implementing the Meditech MPM module itself.With the development o f all the customerdefined-screens, the "out-of-the-box" functionality provided by MPM was overlooked.The implementation meth odology purely focused on using the customer-defined-screens.During the pilot im plem entation phase at the Motheo district in November 2004, it became very clear that this approach will not work, because the MPM sys tem functionality was now compro mised.A strategy was devised to in corporate the "out-of-the-box" CWS functionality together with the EAR into all the customer-defined-screens.This new approach helped the assess ment sites to schedule patient visits in advance and also to schedule their follow-up visit at the referral treatment site.This approach was adopted for all fu ture site implementations and led to a reduction in capturing a patient's visit on the system.The fourth challenge was to convince the FSDOH ARV Management team to include clinical staff (nurses and phy sicians) as users of the Meditech sys tem.Most o f the sites only had the data capturer and the admission clerk as users o f the Meditech system.While the original idea was to create a longi tudinal ARV patient record by captur ing the paper-based information, it had little or no clinical value now, since the clinical staff was excluded to validate data quality.After lengthy discussions among all the provincial role-players it was eventually decided that the imple mentation process will also provide personal computers and printers for at least one nurse per site as well as Meditech access and training.The fifth challenge was to provide a flexible state-of-the-art information sys tem which gave the Department o f Health a clear picture o f the effective ness of its rollout model, but at the same time adapt to ever changing needs.Free State was the first South African prov ince to have a patient profiling system (Shai-Mhatu, 2006) and is still using the Clinic Information System at the time o f w riting this article.N um erous changes have been incorporated since its first implementation in 2004.Initially there were 8 adult forms but by the time o f writing this article there were 28 forms, each with a corresponding CDS.Provision was also made to include data elements of children on the paper forms and the CIS.Since 2004, three phases o f implementation were con ducted.First phase was 27 ARV sites, second phase was 8 ARV sites and the third phase was 10 ARV sites.This meant by the time of writing this arti cle, 45 ARV sites were using the CIS in the Free State province.Finally, approximately twenty (20) func tional changes were made to the CIS to date.The most notable changes include screens capturing data elements on family planning, regimen changes, follow -up changes, p atien t staging changes, prophylaxis changes and user capture analysis.An ARV pharmacy module was also implemented.All of these functional changes were made to accommodate changing needs o f doc tors and professional nurses.Although no formal evaluation was ever done on the CIS, it is clear from the active management involvement in solving the listed challenges, that the FSDOH are happy with the CIS as it co n tin u o u sly asks for functional changes, training and assistance from the vendor.

Conclusion
HIV/AIDS is a global crisis.To combat the effect o f the disease, the South Af rican governm ent started with the provisioning o f ARV therapy in the public health sector.To manage this process effectively in the Free State, an inform ation system was im ple mented.The process started with a paper-based system to collect vital in formation.This was followed by a palmpilot project which was initiated to elec tronically capture the data collected by the paper-based system.This system was then replaced by a comprehensive Hospital and Clinic Information System which was acquired and customised for the ARV data collection process.Data was extracted from these systems and exported to a standalone ARV data warehouse located at the MRC.The purpose of this data warehouse was to collect information associated with the monitoring and evaluation o f the Free State ARV and HIV and AIDS treatment programme.During the development and implementation of the information system several challenges were suc cessfully overcame and the system has been in operation for a number o f years.The logical next step now is to design and implement a single data warehouse for the FSDOH which will incorporate the data warehouse of the MRC.This data warehouse should also include data from other disparate operational systems which are closely linked to HIV/AIDS.Examples of such systems are: ARV Human Resources, Tubercu losis, Notifiable Diseases, Blood Re sults, and Hospitalizations.Such a data warehouse will provide strategic inte grated information to management so that the ARV treatment programme can be managed effectively.
rollout o f a Clinic Information System, once the users are familiar with the ARV treatment programme Paper-based systems have long been

Figure
Figure 1: ARV Forms and Form Flow

Figure 1 :
Figure 1: ARV Forms and Form Flow

FigureFigure 2 :
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