Specific Aims for Cervical Screening and Population Health Innovation

CKD Screening, Diagnostic Testing, Care Planning and Case Mgmt. Domains

CKD Data Domains for Digital Atlas

Fig. 1 Fig. 2

Specific Aims for CKD Health Disparities in African Americans

Ethiopia’s National Cancer Control Program (NCCP) Cervical Cancer Screening Strategy

Patient Engagement Capabilities Provider Collaboration Capabilities Open Source SolutionProject Orchid mHealth Capabilities & Open Source Solution

Ethiopia’s Cervical Cancer Screening Initiative

Specific Aim, Hypothesis and Methods

Background

Cervical Cancer Screening Process Model mHealth Model for Cervical Cancer Screening CKD mHealth Configuration Model

Chronic Kidney Disease (CKD) Digital Atlas for Health Disparity ResearchProject Orchid mHealth Specific Aims and Implementation Models

Bibliography & Contact Info

Project Orchid mHealth Platform Supporting Clinical Innovation associated with Health Disparity Research for High Risk Populations Worldwide

Pssociat

Specific Aim

Hypothesis

We will pilot an open source mHealth platform that enables clinicians and population health scientists to conduct clinical, genetic, and social determinant assessment models for public health initiatives, that verify the risk level and early CKD andcervical cancer, in low resource settings which will result in:

• Improving access to women within the Amhara region of Ethiopia, between the ages of 30 – 49, to receive timely cervical cancer screenings and patient education via mHealth solutions provided to Health Extension Workers, improve population health surveillance efforts for cervical cancer prevention, and increase the capacity of public health researchers to collaborate with multinational cohorts in cancer prevention initiatives.

• Providing timely and actionable clinical and social determinant intelligence associated with health care disparities, to providers, payers and health care policy stakeholders, that contribute to the onset of CKD for African Americans, for person-centered case management.

Methods

Our implementation approach focuses on the reuse of two nationally recognized Open Source ehealth solutions: the Data Collection Application Suite (DCAS) (fig. 1, Screenshot of DCAS mobile solution), a widely used, cloud-based mHealth and metadata platform deployed and adopted nationally for pivotal NIH, CDC public health initiatives, and state-level public health assessments for communicable and noncommunicable diseases for adults and children and RAPTOR (Radiology Protocol Tool Recorder) (fig. 2, Screenshot of RAPTOR’s clinical workflow module), an award winning solution, piloted within the Veteran Affairs Center for Innovation program as a radiology protocol and workflow tool.

Scope of Solution

• Open Source solution derived from two proven technology platforms tested and deployed in regional and national public health initiatives

• 2000+ re-usable instruments and sections implemented within tool

• Supports 17+ Languages including Amharic

Contributors: Kimberly Harding1, Gashaw Andargie Biks, MPH, PhD2, Mulat Adefris2, MD, MPH, Jordann Loehr, MD, MPH2, Kiros Gashave, MD2, Binyam Tilahun, PhD2, Michael Volynski, PhD3, Shashank Garg, PhD4, Tesfaye Mersha, PhD5, Susanne Nicholas, MD, MPH, PhD6, David R. Williams, PhD7, Robert M. Mayberry, MS, MPH, PhD8, Jonathan Medverd MD9, Andrew Casertano10, Frank Font10, Nicholas Polys, PhD11, Walter Magnussen, PhD12

1Monarch Innovation Partners, Inc., Rockville, MD, USA, 2University of Gondar, Gondar, Ethiopia, 3InfoPro Systems Inc., Rockville, MD, USA, 4Digital Innovation Lab, Bangalore, India, 5Cincinnati Children’s Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA, 6David Geffen School of Medicine at UCLA, Los Angeles, USA, 7Harvard T.H. Chan School of Public Health, Boston, MA, USA, 8Morehouse School of Medicine, Atlanta, GA, USA 9University of Washington Medicine, Seattle, WA, USA, 10SAN Business Consultants, LLC, North Potomac, MD, USA, 11Virginia Tech, Blacksburg, VA, USA,12Texas A&M University, College Station, TX, USA

BACKGROUND: Ethiopia’s Cervical Cancer Screening Challenge

In a 2013 report from the Addis Ababa Cancer Registry in Ethiopia, cervical cancer represented 14.3% of all cancer cases, and approximately, two-thirds of cancer deaths. According to the National Cancer Control Program of Ethiopia (NCCP), about 80% of reported cases of cancer are diagnosed at advanced stages, when very little can be done to treat the disease [1-5]. The NCCP attributes these findings directly to the low awareness of cancer signs and symptoms, poor access to screenings, early detection and treatment services; inadequate diagnostic facilities, poorly structured referral systems and shortage of training human resources at all levels of health facilities [1-5]. Given this current assessment, our hypothesis consists of the development of a testable mHealth platform which will produce more timely and reliable medical interventional intelligence due to improved standardization and timely access of clinical and vital statistic data throughoutthe country. This will enable NCCP to achieve its mission: prevention, early detection, research and population-based surveillance.

BACKGROUND: Health disparities associated with the onset of CKD in African Americans

African Americans (AAs) suffer the widest gaps in chronic kidney disease (CKD) outcomes compared to Caucasian Americans (CAs) and this is because of the disparities that exist in both health and healthcare. In fact, the prevalence of CKD is 3.5 times higher in AAs compared to CAs. The disparities exist at all stages of CKD. Importantly, AAs are 10 times more likely to develop hypertension-related kidney failure and 3 times more likely to progress to kidney failure compared to CAs. [6]. These factors are due to both genetic traits and socio-economic disparities in care that require new methods of detection and medical interventions. Current methods for collecting and disseminating clinical intelligence within this high-risk patient population have been insufficient, due to lack of a commonly accepted clinical data set across care settings, and gaps in evidenced-based clinical measures that tie outcomes to socio-economic factors within an AA genetic model [6]. This issue is compounded by a deficiency of patient engagement models that effectively reach patients living in disenfranchised urban and rural settings [6]. As a result, researchers, clinicians, and public health stakeholders have a difficult time correlating CKD cross-trial data setswith reliable patient-level electronic health records for this specific population. This digital divide impacts the progress of CKD Open Science research and adoption of new disease management techniques, especially within the high-risk AA population [6]. We hypothesize that an integrated clinical intelligence platform and patient engagement model will enable researchers, primary care and disease management specialists to measurably improve their approaches and outcomes for predictive disease modeling for CKD biomarker research, patient engagement and medication adherence for AA patients with CKD. Our long-term goal is to provide a novel, integrated clinical intelligence platform for the care of AA’s with CKD, to significantly reduce health disparities.

Project Orchid’s Integrated mHealth Solution

We will test and pilot the platform to support the WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention, for women between the ages of 30-49, in the following care settings within Ethiopia’s Amhara region: Community Health Providers and Health Extension Workers, Health Centers, General Hospitals, and Tertiary Hospitals. The mhealth platform will be built to provide configurable cervical cancer screening and assessment tools that can be installed on a mobile phone, to enable clinicians, healthcare workers and researchers to develop, train, and deploy consistent clinical protocols and data collection methods that will support the following:

• Real-time and offline data collection methods for population-based cervical cancer surveillance in urban and remote-rural locations, utilizing best practices for low connectivity areas with limited telecommunication infrastructure, and embedded interoperability standards to integrate with health information systems, home health medical devices, laboratory information systems, and medical-based barcode readers.

• Configurable metadata-based screening and assessment mhealth tools to identify, detect and report on pathological agents such as HPV, HIV and hepatitis B.

• Provide clinical decision support and patient-level care alerts, integrated within the mobile app, to include health education, vaccinations against viral infections associated with cancers particularly HPV.

• Mobile accessible guidelines (online and offline) to treat infectious diseases causally-associated with cancers (HPV, Hepatitis B, HIV).

• Test the export of data to the University of Gondar’s Public Health surveillance programs for women’s health, the Addis Ababa Cancer Registry, the African Cancer Registry Network, and perform comparative modeling with the NIH-NCI CISNT Model Registry Cervical Group’s inputs: risk factors, screening behaviors, and diffusion of new treatments.

Goal

Perform population-based Cancer Screening Using VIA (Visual Screening using acetic acid) for all women aged 30-49, every 5 years.

Objective

To achieve 80% coverage of VIA to detect precancerous cervical lesions among non-symptomatic women aged 30-49.

Key Interventions

• Conduct community awareness on the availability and importance of VIA and cryotherapy.

• Build human-resource capacity to conduct VIA and cryotherapy.

• Introduce and adopt innovative approaches to rapidly screen large numbers of women, such as HPV testing, in pilot demonstration programs and cryotherapy in a single visit approach.

We will technically validate that the proposed platform can collect clinical and social determinate information that is of relevance to both patients and providers in the screening, assessment, and treatment of CKD. By validating that we can collect this information in an interoperable data network, will enable health and human service stakeholders associated with CKD, to access information in a more timely and consistent manner, with improved data integrity.

Our approach will include our platform’s ability to collect, aggregate and perform data validation at the point of care, on the draft set of data elements identified as important to CKD patient care by the NIH-NKDEP CKD Electronic Care Plan Working Group. In addition, we will incorporate the National Academy of Medicine’s (NAM) Social Behavioral Health Domains and Measures, the CDC’s HealthyPeople health disparities framework, and aspects of the Intrinsic Assessment Tool (IAT), administered by the provider (via a portal mobile health or EHR integrated solution with the platform).

We will compare how the harmonization of these diagnostic instruments will improve the timeliness of detecting high risk patient groups and their prioritization for health and human service interventions compared to current methods used at pre-selected UCLA Medical Center and the Morehouse School of Medicine outpatient clinic sites.

The platform will support a data analytics model that aligns to the Chronic Kidney Disease Prognosis Consortium meta-analysis model, the NIDDK Electronic CKD Care Plan, and an optional data points if available: origin of birth and the APOL-1 genomic biomarker, to produce a comprehensive CKD clinical and genomic patient panel profile.

SPECIFIC AIM: Pilot an integrated clinical, genetic and social determinant assessment model and imaging atlas for pre-CKD screenings that verify the risk level and early onset of CKD.

SPECIFIC AIM: Develop a testable mHealth platform to support Ethiopia’s cervical cancer screenings, care assessments, and public health innovation efforts for prevention and treatment of precancerous lesions for cervical, for women between the ages of 30-49, in low resource settings.

1. World Cancer Research Fund International 2012 Report, Cervical Cancer Statistics [Internet]. 2018. Available from: https://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/cervical-cancer-statistics [Accessed 2018-04-15].

2. Bruni L, Barrionuevo-Rosas L, Albero G, Serrano B, Mena M, Gomez D, Munoz J, Bosch FX, de Sanjose S. (27 July 2017). Human Papillomavirus and Related Diseases in Ethiopia. Summary Report.ICO Information Centre on HPV and Cancer (HPV Information Centre). [Accessed 20 Feb, 2017]

3. Edelstein M, Pitchforth E, Asres G, Silverman Mandy Kulkarni N. (18 July 2008). Awareness of health effects of cooking smoke among women in the Gondar Region of Ethiopia: a pilot survey. BMC International Health and Human Rights8:10doi:10.1186/1472-698X-8-10

4. American Cancer Society. (1 Nov 2017). Cervical Cancer Causes, Risk Factors, and Prevention. Retrieved from https://www.cancer.org/content/dam/CRC/PDF/Public/8600.00.pdf

5. Central Statistical Agency, C.S.A.E. and Icf, Ethiopia Demographic and Health Survey 2016. 2017, CSA and ICF: Addis Ababa, Ethiopia.

6. Harding K, Mersha T, B, Vassalotti J, A, Webb F, J, Nicholas S, B, Current State and Future Trends to Optimize the Care of Chronic Kidney Disease in African Americans. Am J Nephrol 2017;46:176-186

Our primary focus is to support public health research associated with health care disparities, by using mHealth technology for detecting and mitigating health disparities for high risk population groups of African descent: African Americans at risk forchronic kidney disease (CKD) and Ethiopian woman, located in the Amhara region, living in low resource settings with limited access to cervical cancer awareness, screening, and treatment.

The overall strategy of the NCCP is to improve prevention and early detection of cancer, increase capacity for cancer research and optimize population health surveillance efforts

Project Orchid’s mHealth platform will be scalable to support both Sequential Cervical Cancer testing and more sophisticated techniques that require a Cytology program for:

• Health Extension Workers in remote-rural locations

• Gondar local and regional medical centers

• Gondar Public Health Division

• NCCP Sponsors

• African Cancer Research Network

• Potential Collaboration Efforts with NCI Cervical Cancer Workgroup

Scope of CKD Data Domains for Atlas

We will incorporate the following domains into the Atlas:

• Multi-factorial Health Disparity and Environmental Criteria from CMS, CDC and NAM’s Social Behavioral Health Domains

• NKDEP CKD Care Plan Data Set

• Targeted CMS and CDC Pre-CKD and CKD Data Domains

• Targeted CKD Biomarker Taxonomy

• Targeted Precision Medicine “omics”