Pulmonary Fibrosis Advocates Cloud Based Mult-Disease Registry PCORI Grant


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The Pulmonary Fibrosis Advocates cloud based, multi-disease registry proposal for a PCORI challenge grant. The new registry adapts the CDEMS registry using cloud based EHR technology from DataWeb of Puyallup wa. The registry will be directly accessible for patient or provider signup on the web.

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Pulmonary Fibrosis Advocates Cloud Based Mult-Disease Registry PCORI Grant

  1. 1. Pulmonary Fibrosis Advocates - Cloud Based, Patient Accessible, Cross-Disease Adaptable Registry 12401 Minnetonka Boulevard, Suite 200 Minnetonka MN 55305-3994 952.933.9990 | www.pfadvocates.org__________________________________________________________________________________________________________ Creating an Affordable, Easy to Use, Cloud-Based Multi-Disease National Patient Registry Platform for deployment in 2013Executive Summary- Why create a multi-disease national patient registry platform for fibrotic diseases?Progressive scarring of the heart, blood vessels, lung, liver, kidney and brain leads to millions ofdeaths world-wide each year, but to date, there has been no systematic widely available registrycollecting data addressing key issues involved in fibrotic diseases generally: • the course ofdisease; • understanding variations in outcomes; • identifying factors that influence prognosis andquality of life; • defining care patterns and disparities in the care delivery of care; and • measuringquality of care and treatment effectiveness.In its most basic form, a disease registry is an information collection system designed to supportorganized care management.1 Patient registries are fundamental to basic, applied and translationalresearch in disease causation, prevention and treatment, yet most so-called ‘rare diseases’ (thosewith patient populations of less than 200,000) lack research-enhancing registries. An estimated 60million people in Europe and North America are living with such rare diseases.One example is idiopathic pulmonary fibrosis (IPF), which kills an estimated 40,000 Americanseach year, comparable to the toll for breast cancer. Although IPF is showing alarming increasesin incidence and prevalence, there is no known cause or FDA-approved treatment nor is there anational registry for IPF.We intend to create an intuitive, web-based registry platform designed to address issues that wouldbe applicable for all rare, low and intermediate frequency fibrotic diseases. Such a registry, usingIdiopathic Pulmonary Fibrosis as the pilot disease, but readily and affordably adaptable to otherdiseases, including non-fibrotic illnesses, will fill a critical void in our public health infrastructure andwill benefit patients, families, treatment providers, researchers, pharmaceutical and deviceindustries and policy makers2.Until now, patient registries have been based on custom software and data management programscreated for specific diseases with the software and data stored on local networks. These locallymanaged networks and registries are typically expensive to build and are not easily accessible bypatients or by researchers beyond local or regional research or clinical groups.With the introduction of cloud computing and a new generation of software development tools, it isnow possible to build a first class disease registry that can be securely accessible to patients andto the entire health care community. This new registry platform, carefully designed with easy, web-based entry-level access to patients, family members and caregivers, will exponentially increasepatient participation – especially participation by currently under-served and under-representedpatient communities.The new registry platform will be created by merging an existing and widely used diseasemonitoring program with a commercially available, HIPAA compliant cloud-based softwaredevelopment platform. The system will be designed to be adaptable to the unique needs of different -1-
  2. 2. Pulmonary Fibrosis Advocates - Cloud Based, Patient Accessible, Cross-Disease Adaptable Registryillnesses and research protocols and will address HL7 standards for cross platform compatibilitywith diverse EHR/EMR systems. We estimate that the system will be operational for initialapplication to pulmonary fibrosis nationwide by the end of 2013.This new multi-disease national patient registry platform effort is consistent with the JOINTDECLARATION OF KEY PRINCIPLES FOR RARE DISEASE PATIENT REGISTRIES that was announced inNovember of 2012 by the European Organization for Rare Diseases (EURORDIS), the NationalOrganization for Rare Disorders (NORD) and the Canadian Organization for Rare Disorders(CORD) including:  “Patient Registries should be recognized as a global priority in the field of Rare Diseases  “Interoperability and harmonization between Rare Disease Patient Registries should be consistently pursued  “A minimum set of Common Data Elements should be consistently used in all Rare Disease Regsitries  “Rare Disease Registries should include data directly reported by patients along with data reported by healthcare professionals  “Public-Private Partnerships should be encouraged to ensure sustainability of Rare Disease Patient Registries, and  “Rare Disease Patient Registries should serve as key instruments for building and empowering patient communities” http://rarediseases.org/docs/registries-2012Sponsoring OrganizationConsistent with the intent of the PCORI grant, this initiative originated with and is being sponsoredby the PULMONARY FIBROSIS ADVOCATES, a national not-for-profit [501(c)(4)] advocacy groupconsisting of patients, families, caregivers, clinicians and researchers. Our Board of Directors3includes former six-term Congressman Brian Baird, Ph.D., whose father died of PF and whosponsored legislation in Congress to create a PF registry. Our Director, Paul Fogelberg, is a PFpatient and patient support group leader. Our clinical team is led by a uniquely experienced andhighly-regarded 7-member MEDICAL ADVISORY BOARD4 and we have pledged to incorporate othervital stakeholders from the patient, public and private sectors deemed essential to refining the mostuseful and widely effective format for the new registry platform.Softw are and System Design Elements and TeamSoftware design & development is led by DataWeb of Puyallup WA(dataweb.com), an early entrant in cloud computing and electronic healthrecords. DataWeb’s fully hosted software development technologies form the foundation of fullfeatured electronic health records application currently in use at a number of colleges as theapplication for teaching EHR concepts and usage. The DataWeb Platform is scheduled to be fullyHIPPA compliant by May 15, 2013. Another major benefit of working with DataWeb is its uniqueability to provide web-based language-translation services making the new patient registry platformespecially user-friendly to the non-English speaking population. By using DataWeb’s hostedlanguage services application, translation services can be quickly provided at the time the patientis registered. We will also partner with nationally respected public and private medical researchcenters that currently use HIPAA-compliant servers to host and facilitate the collection anddistribution of registry data. Instructions and links to the DataWeb EHR Website are provided onthe accompanying final submission form and at the end of this document after the references. -2-
  3. 3. Pulmonary Fibrosis Advocates - Cloud Based, Patient Accessible, Cross-Disease Adaptable Registry In addition to the unique expertise and market-proven resources of DataWeb, we will incorporate field-tested designs and experience from the Chronic Disease Electronic Management System. CDEMS is a software application developed by the Washington State Diabetes Prevention and Control Program in 2002. It is a Microsoft Accessdatabase application designed to assist medical providers and management in tracking the careand outcomes of patients with chronic health conditions.CDEMS is pre-coded to track diabetes, asthma and adult preventive health but is customizable tochange those tracking measures or define measures for monitoring other chronic conditions.Printed progress notes, patientintervention lists, and summaryreports generated from theregistry database can proactivelyand positively alter the wayservices are delivered whilemeasuring quality improvementefforts. Since its inception,community health centers, ruralclinics, primary practices,hospitals, IPA’s and qualityimprovement projects have usedCDEMS across the US and inCanada, India, Haiti, the MarshallIslands and South Africa. Themap shows many of the sitesusing CDEMS in the USA andlists others.There are many advantages to using CDEMS as a basis for this initiative. As noted, CDEMS wasdesigned to be customizable in order to accommodate the requirements of other chronic diseases.The sustained and ongoing experience with the system, it’s proven adaptability in applicationsacross diseases and its broad existing user base across the nation (and worldwide) means it hasbeen tested and proven in multiple applications and has a strong existing community of users whoare familiar with the system. At this point, the main need is to make CDEMS accessible on thecloud and allow for wide user-friendly direct patient, clinician and researcher interface.Primary support for CDEMS today comes from the Office of HealthServices Research (OHSR) at West Virginia University, which hasmade extensive use of, and substantial updates and upgrades to the system. The Leader of theOHSR team at WVU has agreed to work with us on this project. The direct link to the CDEMS sitenow maintained by OHSR at WVU (including a download of the software and accompanyinginformation) is http://publichealth.hsc.wvu.edu/ohsr/Dowloads. Login instructions for theCDEMS Website, and a link to an instructional video for the download, are included at the end ofthis submission following the references.Based on guidance from our patient, clinical and research advisory team, our initiative will updateand adapt CDEMS to make the system cloud-based for easier accessibility to patients, physiciansand researchers. In addition, we will allow for new data sets to be included, ensure full HIPAAcompliance regarding permissions, informed consent, data storage and access and other matters.Our planning will also accommodate future enhancements including incorporation of HL7Standards [Health Level Seven International – www.hl7.org/about/index.cfm?ref=nav] forcompatibility and eventual interface with multiple EHR/EMR systems. -3-
  4. 4. Pulmonary Fibrosis Advocates - Cloud Based, Patient Accessible, Cross-Disease Adaptable RegistryPatient EngagementA key element of this project, enabled by its cloud-based adaptation, is to establish simple browser-based mechanisms by which patients, families, caregivers, clinicians and researchers can moredirectly access and interact with registries. Presently, nearly all patient registries depend onproviders or researchers soliciting patients for entrance. Our new registry system will allow patientsto directly access a user friendly, browser-based interface through which they can sign up for theregistry and enter basic information about their condition and treatment. This unique entry-levelaccess for patients will be part of a tiered (and appropriately fire-walled) access structure designedto promote the maximum level of patient sign-ups while also providing necessary restricted accessto more technical information provided by the patient’s health care team or researchers.The rationale for this new approach is that many patients are willing and eager to participate inresearch and would be glad to voluntarily sign up for a registry if given the opportunity and a user-friendly mechanism for doing so. Currently, unless a willing patient lives near a specializedresearch center or has a health care provider involved in a defined research protocol, this is noteasily or practically accomplished. Indeed, from the patient’s perspective, in most instances it isimpossible. As noted previously, this new registry platform will exponentially increase patientparticipation – especially participation by currently under-served and under-represented patientcommunities.Because the system proposed here will be cloud-based, patients will be able to access it directlyfrom standard web browsers or apps at home or in any provider’s office. Protocols will beestablished through which researchers can access the database to identify and enlist suitablepatients for participation in research studies and/or clinical trials. With help from patients, clinicians,research and technology team members, a standard process will be established with appropriatesecurity and participation protocols to determine how access to the data for research use is granted,and for what purposes.Idiopathic Pulmonary Fibrosis (IPF) as the Demonstration DiseaseIdiopathic Pulmonary Fibrosis is an ideal disease to demonstrate the functionality of this multi-disease registry platform. Progressive scarring of the heart, blood vessels, lung, liver, kidney andbrain leads to millions of deaths world-wide each year. Idiopathic Pulmonary Fibrosis (IPF) is aprototype for this class of disorders.IPF is a progressive scarring of the lungs estimated to afflict 200,000 Americans and up to 1 millionpersons world-wide. In IPF, there is unrelenting spread of scar-forming cells from scarred airspacesinto contiguous anatomically intact airspaces. This creates an expanding web-like network of scartissue that causes death by asphyxiation in an average of 3 to 5 years. Although the cellular andmolecular events characterizing IPF have been extensively investigated for more than threedecades, there are still no FDA-approved drugs for IPF. The only proven therapeutic option is lungtransplantation.5Presently, IPF claims as many lives each year as breast cancer (40,000), yet it has no nationalpatient registry, there are relatively few ongoing clinical trials, and there is presently no knowncause or effective treatment. Establishment of a national patient surveillance registry has beenidentified as a top priority by patients, patient advocacy groups, both treating and researchphysicians and pharmaceutical companies. The NHLBI Workshop, Strategic Planning for IPFResearch (Nov. 27-28, 2012) Executive Summary notes the need to: -4-
  5. 5. Pulmonary Fibrosis Advocates - Cloud Based, Patient Accessible, Cross-Disease Adaptable Registry “• Develop additional clinical tools and collaborations among different stakeholders to facilitate future clinical trials/studies of IPF;” and “• Identify new, creative means for conducting efficient and cost-effective clinical trials and for partnering with industry to sponsor phase II/III clinical trials.” http://www.nhlbi.nih.gov/meetings/workshops/fibrosis.htmPF patients have shown themselves to be desirous of more research and are highly amenable toparticipation. A strong network of PF patient support groups exists nationwide – at least 76 groupsin 34 states - and could quickly publicize and disseminate information about the registry, explainwhy patients should sign up and help them do so. These efforts will be further aided by nationalorganizations such as the PULMONARY FIBROSIS ADVOCATES (PFA), the Pulmonary FibrosisFoundation (PFF) and through effective use of social media (including Facebook, Twitter andvarious patient websites and blogs). A broad and willing pilot patient population – as exists in thePF community – is the ideal prototype to test and refine the pilot-project.Projected CostBy using the CDEMS design and architecture, plus the rapid development and integrated securityfeatures of the DataWeb Platform, we will deliver a first class disease registry application at a muchreduced cost. Estimated costs for developing and refining the DataWeb and CDEMS software andapplying it to a single disease, beginning with pulmonary fibrosis (but readily adaptable to virtuallyall other fibrotic diseases), is approximately $80,000 to $100,000. For comparison purposes,current disease-specific registries often have development costs that exceed millions of dollars andare, therefore, prohibitive to implement for most so-called ‘rare’ illnesses.Once established, the new registry platform will be made available to other diseases and patientpopulations, with relatively small costs of adaptation and refinements of sustaining specificapplications to be generated by combined efforts of additional patient groups, clinicians, researchusers, and private sector interests such as insurance companies, pharmaceutical or medical devicecompanies as appropriate to the specific illness and treatment approaches. How This Proposal Meets Evaluation Criteria1. The actual or described technical capacity to efficiently and effectively connect patients and researchers, across multiple platforms and levels of complexity.The integration of an existing data registry (CDEMS) in combination with a commercially successfulcloud-based EMR system (DataWeb) and the involvement of the programming expertise from thoseentities demonstrate that the technical capacity is present to achieve project goals. In addition, thepatient, medical and research advisory team includes some of the nation’s most prominent andrespected treatment and scientific professionals in fibrotic diseases.On the patient side, PULMONARY FIBROSIS ADVOCATES includes patients from across the countryand has direct tie-in support from multiple PF Patient Support Groups. The PFA is also in closeworking contact with other, related organizations and we have pledged to work cooperatively withthem to design, build and disseminate information about the registry. As described above, theregistry will be designed to have entry level, self-initiated patient enrollment and basic demographicand disease data entry. There will then be a second level data access element for more technicalclinical or other research information to be entered as dictated by treating physicians and/orresearch personnel. The registry will be easily customizable by expert researchers and treatmentprofessionals for each specific disease entity, treatment, or research protocol. -5-
  6. 6. Pulmonary Fibrosis Advocates - Cloud Based, Patient Accessible, Cross-Disease Adaptable Registry2. Usability, scalability and sustainability across diverse populations with differing levels of access to, understanding of and experience with technology and health/health care information.This criterion is really at the essence of our proposal. The CDEMS platform has already shownpractical adaptability across multiple diseases and settings and is currently in use in many differentlocations around the world; however, it is not cloud-based. Therefore, the system we are designingwill enhance access to any stakeholder who has internet connectivity. By placing the system onthe cloud, and allowing for direct web-based interface, patients across the country, whether in ruralor other underserved settings, will be readily able to participate. Many patients, such as those withPF, are often so ill it is hard to come in to clinics or other settings where fixed location registries arehoused. By accessing the system on the web, patients, or close family members, can sign on andenter data without having to visit a clinic or research site. This feature will also make “real time”data entry much more practical for patients, which has significant research and treatmentadvantages. We will also provide the ability for patients (or family members/caregivers) to easilyrequest translation and interpretation services at the time of registration. This will eliminate anotherbarrier that often makes it difficult for non-English speaking patients to take full-advantage of theseimportant registry resources. Our registry platform is designed to be user-friendly in both contentand technical interface so an average individual with basic linguistic and computer literacy caneasily sign up for the registry and enter core data. If additional, more technical data is needed, thatcan be accomplished with assistance of medical or research staff as needed for a given purpose.3. Degree of development of the model or prototypeA significant advantage of this proposal is that the core platforms, the CDEMS registry and theData Web Platform, are already operational and proven. The programming team at DataWebspecializes in translating database systems into cloud-based structures. That Team has alreadyreviewed the underlying CDEMS design and code. Their market-tested technology team isconfident it can be adapted to meet the requirements described in the proposal within six-to-eightmonths (i.e., in 2013).4. Differences in the ways that patients, caregivers and researchers understand, describe and seek answers to the problems they face or the issues they’re trying to address (e.g., different terms for similar concepts, general levels of health literacy, etc.).Unlike most existing (institution-specific) registries, this new registry platform directly empowerspatients and many more caregivers by allowing and encouraging patients to sign themselves upfor patient registries. In addition, uniform protocols for access and use of these registries willfacilitate both public and private researcher to access exponentially expanded patient populationsfor research and clinical trial purposes. The advantage of a single, national (or international)cloud-based multi-disease national registry platform will minimize conflicts in definitions andprotocols that currently inhibit wide adoption or use of research-friendly patient information.5. Maximizing “patient-centeredness” – ability to account for and effectively focus on and address patients’ needs – while also emphasizing and facilitating researchers’ need to emphasize the scientific rigor of any resulting collaboration.Prior items have detailed how patient access to and participation in registries will be transformedby the system the PFA is developing. We will use a tiered access system which allows patients tosign up with basic personal and demographic information but will limit access to more technicalinformation to ensure accuracy and validity of that data. The precise nature of the technical datato be gathered will be guided by the medical and research advisory panel for each specific disease -6-
  7. 7. Pulmonary Fibrosis Advocates - Cloud Based, Patient Accessible, Cross-Disease Adaptable Registryto which the registry is ultimately applied. This tiered approach provides the maximum patientinvolvement while still preserving the rigor of the research data.6. The particular challenges of serving "hard-to-reach" audiences, including, but not limited to, ethnic and racial minorities, rural populations, the elderly, the disabled/ physically challenged (i.e., Section 508 compliance) and those for whom English is a second language.As described in item 5 above, direct web access will significantly enhance accessibility issues torural and other underserved populations. So too, user-friendly web access will enhance access bypersons whose illness or disability makes it difficult to come in person to research or clinicalsettings. For ESL issues, as noted above, our unique registry platform design features the abilityfor patients (or family members/caregivers) to easily request translation and interpretation servicesat the time of registration. This will eliminate another barrier that often makes it difficult for non-English speaking patients to take full-advantage of these important registry resources._____________________________________________________________________________Footnotes1 US Department of Health and Human Services, Health Information Technology and Quality Improvement; HHS web site, March 2013 See also: Registries for Evaluating Patient Outcomes: A User’s Guide, 2nd Ed., Gliklich, RE, Dreyer, RA, editors, Agency for Healthcare Research and Quality, September 2010, Rockville MD2 Registry of Patient Registries (RoPR) http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and- reports/?pageaction=displayproduct&productid=6903 PFA Board of Directors (7 members) Brian N. Baird, Ph.D. Edmonds WA Former United States Representative (D, WA-3 / 6 terms) Paul A. Fogelberg Minnetonka MN Patient-Advocate & Director, PFA; President, The Professional Education Group Dr. Jerome (Jerry) & Froma Sandler Bethesda MD Lisa Sandler Spaeth Memorial Pulmonary Fibrosis Research Fund, Johns Hopkins University C. Thomas Vangsness, Jr., MD Los Angeles CA University of Southern California Mark A. Shreve Titusville NJ Founder & CEO, Coalition for Pulmonary Fibrosis (‘01-‘09); Senior Advisor, Pulmonary Fibrosis Foundation (2010-present) Timothy P.M. Whelan, MD Charleston SC Medical Director of Lung Transplantation, Medical University of South Carolina4 PFA Medical Advisory Board (7 members) Peter Bitterman, MD Professor of Medicine, Vice Chairman of Research, Department of Medicine, University of Minnesota, Minneapolis Timothy P.M. Whelan, MD Medical Director of Lung Transplantation, Medical University of South Carolina, Associate Professor of Medicine Lawrence C. Mohr, MD Professor of Medicine, Biometry and Epidemiology and Director of the Environmental Biosciences Program at the Medical University of SC Joao de Andrade, MD Associate Professor; Associate Director, Pulmonary Fellowship Program; Director, UAB Interstitial Lung Disease Program – UAB Health System -7-
  8. 8. Pulmonary Fibrosis Advocates - Cloud Based, Patient Accessible, Cross-Disease Adaptable Registry Richard Castriotta, MD Prof. of Internal Medicine, Pulmonary Division Dir. and Chair-Elect of the Interfaculty Council at the Univ. of Texas Health Science Center at Houston; Chief of Pulmonary Medicine, Chairman of the Institutional Ethics Committee and Medical Director of the Sleep Disorders Center at Memorial Hermann Hospital in the Texas Medical Center Jesse Roman, MD Professor and Chairman of the Department of Medicine, Distinguished University Scholar, University of Louisville, KY Kevin M. Chan, MD Medical Director, Lung Transplantation, University of Michigan Health System5 Registries for Evaluating Patient Outcomes: A User’s Guide: 2nd Edition http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and- reports?/pageaction=displayproduct&productid=401_____________________________________________________________________________Login instructions for CDEMS at West Virginia Universityhttp://publichealth.hsc.wvu.edu/ohsr/DownloadsFrom that link the CDEMS software can then be downloaded and explored along with documentation,reports, training videos etc.. CDEMS requires Microsoft Access to run. For an instructional video to assistin the installation process of the CDEMS software, see http://www.youtube.com/watch?v=fdKq21Z31joLogin Instructions for DataWeb EHR application as used in teaching settings at theUniversity of Washington - NB (This works best if accessed through Internet Explorer): 1. http://combsjbl.varipoint.com 2. Username: teststudentehrlab 3. Password: aloha123 Once on the site, click the ‘Select’ button to enter From there, since this link is to a teaching demo of the EHR program, one can select the profession level for which lessons are tailored, e.g. receptionist, nurse etc. Once this is selected, samples of the database fields in the EHR system that would be accessed by those professionals are provided. To see the kind of information available in the system, click the drop down menu bars in the dark background across the top of the page. ______________________________________________________________________ Copyright © 2013, PULMONARY FIBROSIS ADVOCATES, Minnetonka, MN – All Rights Reserved -8-