Background: In high-income countries (HICs), increased rates of survival among pediatric cancer patients are achieved through the use of protocol-driven treatment. Compared to HICs, differences in infrastructure, supportive care, and human resources, make compliance with protocol-driven treatment challenging in low-and middleincome countries (LMICs). For successful implementation of protocol-driven treatment, treatment protocols must be resource-adapted for the LMIC context, and additional supportive tools must be developed to promote protocol compliance. In Tanzania, an LMIC where resource-adapted treatment protocols are available, digital health applications could promote protocol compliance through incorporation of systematic decision support algorithms, reminders and alerts related to patient visits, and up-to-date data for care coordination. However, evidence on the use of digital health applications in improving compliance with protocol-driven treatment for pediatric cancer is limited. This study protocol describes the development and evaluation of a digital health application, called mNavigator, to facilitate compliance with protocol-driven treatment for pediatric cancer in Tanzania. Methods: mNavigator is a digital case management system that incorporates nationally-approved and resourceadapted treatment protocols for two pediatric cancers in Tanzania, Burkitt lymphoma and retinoblastoma. mNavigator is developed from an open-source digital health platform, called CommCare, and guided by the Consolidated Framework for Implementation Research. From July 2019-July 2020 at Bugando Medical Centre in Mwanza, Tanzania, all new pediatric cancer patients will be registered and managed using mNavigator as the new standard of care for patient intake and outcome assessment. Pediatric cancer patients with a clinical diagnosis of Burkitt lymphoma or retinoblastoma will be approached for participation in the study evaluating mNavigator. mNavigator users will document pre-treatment and treatment details for study participants using digital forms and checklists that facilitate compliance with protocol-driven treatment. Compliance with treatment protocols using mNavigator will be compared to historical compliance rates as the primary outcome. Throughout the implementation period, we will document factors that facilitate or inhibit mNavigator implementation.
PURPOSE Use of standardized treatment protocols has been demonstrated to improve outcomes for pediatric patients with cancer. Yet it is challenging to implement standardized treatment protocols in low- and middle-income countries as a result of infrastructure and resource constraints, as well as poor health provider compliance with treatment protocols. At Bugando Medical Centre (BMC) in Tanzania, health provider compliance with standardized paper-based treatment protocols is low at 22%. One-year overall survival rates among pediatric patients with cancer at BMC are 40% and almost one third of patients abandon treatment. We posit that improving protocol compliance in this setting may decrease treatment abandonment and improve survival rates. Use of digital case management systems has been shown to improve compliance with treatment protocols because of the ability to incorporate such features as decision-support algorithms, prompts and alerts, and checklists. The digital health application mNavigator was designed to facilitate health provider compliance with standardized pediatric cancer treatment protocols in Tanzania. METHODS mNavigator was developed by adapting an open-source digital case management platform called CommCare. The three stages of mNavigator development were as follows: workflow mapping and form development; form programming in CommCare; and quality assurance using mock and deidentified patient records to identify errors in information flow or outputs, assess preliminary usability, and determine areas for improvement. Standardized treatment protocols for Burkitt lymphoma and retinoblastoma were initially incorporated into mNavigator. The mNavigator prototype underwent usability testing at BMC before implementation in routine clinical practice. RESULTS Preliminary system usability, acceptance, and satisfaction evaluation demonstrated high usability response scores (> 80%). Perceived benefits of the mNavigator system included a user-friendly interface, improved record keeping, and assistance with patient tracking using standardized treatment protocols. Suggestions for improvement centered on the incorporation of other standardized treatment protocols (eg, Wilms tumor), improving interoperability with existing electronic recordkeeping systems, and making similar systems available for other clinical departments. CONCLUSION To our knowledge, mNavigator is the first digital health case management system specifically developed to improve health provider compliance with pediatric cancer treatment protocols in a low-resource setting. With high usability and acceptability, mNavigator has been implemented in routine clinical practice. Implementation and patient outcomes evaluations are ongoing and will inform the scale-up for use in other low- and middle-income countries.
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