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Accessibility solutions for PRO management

Award Information

Department of Health and Human Services
Award ID:
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
Solicitation Year:
Solicitation Topic Code:
Solicitation Number:
Small Business Information
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Phase 1
Fiscal Year: 2010
Title: Accessibility solutions for PRO management
Agency: HHS
Contract: 1R43NS067866-01A1
Award Amount: $311,926.00


DESCRIPTION (provided by applicant): Our ultimate project goal is to develop a patient-reported outcomes (PRO) management system specifically designed to address the functional limitations experienced by people with physical and neurocognitive disabilities . We recognize that there are many clinical conditions that could cause these functional impairments, but intend to demonstrate the technical feasibility of our solution in Phase I by focusing on a single disease, multiple sclerosis (MS), for a more practi cal and manageable Phase I scope considering the Phase I budget and timeframe constraints. MS is ideal to begin the study of disability-related PRO solutions in a well circumscribed population since people with MS experience most of the functional limitati ons associated with other disabilities. In Phase II we will seek to expand our project scope to validate our solutions with other disability and rehabilitation populations. This new product will be developed based on our existing PRO management solution ca lled BrightOutcome , that already supports such advanced features as the administration of adaptive PRO measures (including PROMIS item banks), the support of multiple delivery platforms, the rules-based delivery of tailored patient education contents, a nd the coordination of care via reminder/alert messages. Although the BrightOutcome System was initially designed for oncology practices, it provided a solid technical foundation to expand to other disease domains. For the disability and rehabilitation pop ulations, however, the current BrightOutcome System does not yet offer a comprehensive accessibility solution, which is the focus of this Phase I project. To address the accessibility issues, our Phase I specific aims include: 1) the design and development of a PRO assessment interface specifically for MS patients with various functional impairments using different technology platforms (e.g., Web, touch-screen, speech/voice, and phone) via personal interviews and an iterative user-centric design process; an d 2) the evaluation of system usability and user acceptance in both monitored (with usability engineers present) and realistic, un-monitored conditions. To ensure that our solution will be adequate not just for MS patients but for other disability and reha bilitation patients as well, we will assemble a multidisciplinary Expert Panel (physical therapy, occupational therapy, rehabilitation counseling, neuropsychology, assistive technologies, and PRO) to advise on our study design and analysis. PUBLIC H EALTH RELEVANCE: Whereas for a long time, MS was primarily considered a disease of ambulation or motor function, it is now recognized that visual symptoms, fatigue, cognitive impairment, depression, pain and sleep disturbances significantly contribute to t he burden of disease and the overall functioning of MS patients. The effects of the hidden disabilities on the level of disability are significant. However, these MS symptoms and even more their complex relationship to each other are poorly understood. P atient reported outcomes are more predictive of patient health status and disability than objective measures, such as lesion load assessed by MRIs and other biophysical measures. Brief, yet reliable measurement tools of self-reported outcomes are essential in order to evaluate an individual's disease course, or to assess therapeutic benefits of specific interventions, pharmacological or otherwise. The proposed research will generate and validate tools to perform such measurements with direct clinical and re search applications for the MS population. Barriers of PRO accessibility, though, are not limited to the MS population. People with other common disabilities, such as epilepsy, Parkinson's disease and other chronic impairments of bodily function endorse li mitations of accessibility as well. As an example, patients with epilepsy commonly display a wide range of brain disease with associated physical, cognitive, educational and economic disease burden. Epilepsy is of great socioeconomic importance and PRO is expected to have the potential to improve clinical monitoring, drug adherence, overall clinical care and facilitate research of related topics.

Principal Investigator:

Dershung Yang

Business Contact:

Dershung Yang
Small Business Information at Submission:

CARACAL, INC. 1110 Lake Cook Road BUFFALO GROVE, IL 60089

EIN/Tax ID: 161140443
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No