Phase II - Multiple Sclerosis Patient-Powered Research Network and Phase II - Healthy Mind Healthy You and Phase II - A Model for Improving Patient Engagement and Data Integration with PCORnet Patient-Powered Research Networks and Payer Stakeholders

Project: Research project

Project Details

Description

Phase II - Multiple Sclerosis Patient-Powered Research Network and Phase II - Healthy Mind Healthy You and Phase II - A Model for Improving Patient Engagement and Data Integration with PCORnet Patient-Powered Research Networks and Payer Stakeholders Multiple Sclerosis Patient-Powered Research Network (MS-PPRN), iConquerMS It is with great enthusiasm that I write this Letter of Support indicating my commitment to serve as Coordinator for Information Technology (IT) for for Multiple Sclerosiss (MS) ongoing effort associated with the Multiple Sclerosis Patient-Powered Research Network (PPRN). In this capacity, I will be responsible for conceptualizing the IT components necessary to address the specific needs of the PPRN; coordinating the ongoing maintenance and extension of the PPRNs data infrastructure; and interfacing with the broader PCORnet to facilitate interoperability. As you are aware, I am Director of Arizona State Universitys (ASU) Complex Adaptive Systems Computational Science and Informatics program and I have over 30 years of experience in executing and supporting IT efforts in biomedicine. The MS PPRNs data capabilities are delivered through the modular, interoperable iConquerMS IT infrastructure. The iConquerMS framework includes a user Portal, Survey Engine, EHR Management Engine, and a Data Engine. As Coordinator for IT, I will execute the business arrangements and supervise the development, deployment, support, and hosting efforts of our partner Life Data Systems Inc. (LDSi). Day-to-day management of the LDSi components and project management will be performed by Mr. William Tulskie, a colleague with whom I have worked for almost 10 years. Mr. Tulskie has over 30 years of experience in systems and technology development, including work at Litton Systems, IBM, and HealthCare IT, Inc. LDSi is a small business that developed open source components that currently support the iConquerMS infrastructure. They also provide cloud-based, HIPAA-compliant, secure, high-performance IT hosting. Phase II: A Multiple Sclerosis Patient-Powered Network Multiple Sclerosis Patient-Powered Research Network (MS-PPRN), iConquerMS Research Plan and Reference will be using funding to go towards: 1. Project Management 2. Portal Software Security 3. Survey Maintenance 4. CDM Updates 5. Healthcore Support 6. Housing Expansion Phase II: Healthy Mind, Healthy You - Revision 3 Work is for IT services as a subcontractor to /iConquerMS (MS-PPRN) for its contribution as a subcontractor to PCORI-Funded Projects Entitled: Healthy Mind, Healthy You Phase II: A Model for Improving Patient Engagement and Data Integration with PCORnet Patient-Powered Research Networks and Payer Stakeholders - Revision 4 Work is for IT services as a subcontractor to s contract for the Phase II Extension and Budget Reallocation for the PCORI-Funded project entitled: The Multiple Sclerosis Patient Powered Research Network, iConquerMS Partnering to Build Capacity for PCOR/CER in the Pediatric MS Community-Revision 6 Prioritizing COVID-19 Questions in a Participant-Driven Research Process-Revision 7 Building Capacity for Care Partner Engagement for PCOR/CER in Multiple Sclerosis Mood Disorders and Emotional Well--being in People with Multiple Sclerosis (MS):Comparative Characterization and Responses to Online Behavior Modification. A collaboration between the iConquerMS PPRN (PI: Robert McBurney, PhD) and the MOOD PPRN (Co--PI: Allen Doederlein, President of the Depression and Bipolar SupportAlliance). The iConquerMS PPRN and MoodNetwork PPRN are collaborating to conduct a PCORnet PPRN Demonstration Project to compare the characteristics of mood disorders, primarily depression and anxiety, in people living with MS and a population of people not affected by MS or another autoimmune or chronic medical condition; to compare the benefits and harms in people with MS of selected online behavioral therapies; and evaluate the PPRN collaboration, methods, survey tools, and treatments and provide well-documented procedures and materials to PCORnet Commons. The Study will be conducted in two phases under a single study protocol that will be developed during the first six months of the project in parallel with: the instantiation and pilot testing of the survey instruments on the iConquerMS.org portal; the development, instantiation and pilot testing of the online interventions on the MoodNetwork.org portal; the development of a plan for recruitment, engagement and retention of study subjects for Phases 1 & 2; and, the development of a plan to disseminate information about the Study and its results to participants of the PPRNs, researchers, the PCORnet Commons, PCORI and all stakeholders. Both PPRNs have agreed that the protocol will be submitted to a single Institutional Review Board (Copernicus/WIRB) for approval. In Phase 1, 1,000 people with MS will be enrolled from the participants in the iConquerMS PPRN and 1,000 people who do not have MS, another autoimmune disorder or chronic non-behavioral medical condition will be enrolled from the MoodNetwork PPRN. These 2,000 study subjects will complete, during a short time period following enrollment, a single instance of each of 5 well-validated survey instruments designed to collect information about their neurological status, general health, and emotional well-being. Analysis of the data collected on these survey instruments will allow the comparison of the characteristics of mood disorders between these two populations as described below. In Phase II, 600 subjects will selected, based on inclusion/exclusion criteria from the up to 1,000 MS people with MS completing the Phase I surveys, to participate in the interventions and assessments phase of the Study. The selected subjects will be randomized to undertake 8 weeks of either online CBT or online MBCT that they will access online from the MoodNetwork.org portal. Each Phase II subject will complete the same survey instruments as in Phase I on a number of occasions over a 14 month period: at baseline, at 2, 4, 6, and 8 weeks during the intervention period and at 1, 3, 6, & 12 months after the intervention period. Analysis of the data collected on these survey instruments will allow the comparison of the effectiveness of two online behavioral therapy interventions in improving mood and emotional well-being in people with MS and will determine patient characteristics associated with positive outcomes to the interventions both overall and intervention-specific. The Specific Aims are: 1. Identify and characterize mood disorders associated with MS by using validated survey instruments to compare the symptoms and related features of mood disorders among a cohort of people with MS (MS Cohort) and a cohort of people with well-characterized mood disorders and no MS or other chronic medical condition (Mood Cohort). 2. Compare the effectiveness of two online behavioral therapy interventions (CBT and MCBT) in improving mood disorders among randomly assigned members of the MS cohort by using the validated survey instruments as patient-reported outcome measures. 3. Determine patient characteristics associated with positive outcomes both overall and intervention-specific. Multi-stakeholder Engagement for Enabling Patient-Driven Research During the project, Dr. Buetow will coordinate the IT components necessary to maintain and keep current regarding software updates, etc., the capabilities of the iConquerMS.org portal needed for the project and will work closely with ASU subcontractor Ordinal Data, Inc., (ODi) for the projects IT services. He will participate in all iConquerMS meetings related to the project. IT-related activities will encompass: iConquerMS.org portal build out for patient-driven research capabilities - Information on public facing page for ongoing iConquerMS research activities - Enhance portal to support, or link to, educational materials about research - Portal updates to implement necessary capabilities for patient-driven research conducted via iConquerMS (topic submission, commenting, researcher response, topic prioritization, topic sorting, etc.) - Updates to For Researchers area of portal to provide information about engaging with iConquerMS for patient-driven research - Beta testing and review of portal updates Deliverable: iConquerMS portal capable of supporting patient-driven research capabilities
StatusActive
Effective start/end date9/5/155/31/23

Funding

  • Patient-Centered Outcomes Research Institute (PCORI): $1,155,125.00

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