The PROsIT Project seeks to promote the use of Patient-Reported Outcomes (PROs) in both clinical and research practices for AIDS by developing and commercializing a comprehensive, practical and integrated system for PROs management with crossdiscipline efforts. It offers innovative solutions to user accessibility and item bank management issues.

The specific Phase 1 aims are to: 1) develop the prototype of an Item Response Theory (IRT)-based adaptive PROs assessment engine supporting access from both web and phones; 2) elicit system requirements from both patients' and physicians' perspectives; and 3) identify potential system usage barriers in clinical settings.

This study extends from our earlier work on computerized outcomes solutions for AIDS and cancers. The FAHI questionnaire will be used. Focus group discussions with physicians and patients and face-to-face interviews with pilot-testing participants will be conducted to evaluate system usability and usefulness, refine requirements, and identify potential barriers.

PROsIT is a generic outcomes collection, analysis and reporting solution applicable to AIDS and other diseases. It enables researchers to further understand the strengths and limitations of PROs in helping clinical decisions by reaching to a broader patient base. It also has wide-ranging applications for pharmaceutical companies, hospitals, insurers, and government agencies and accreditation organizations.

The PROsIT Project seeks to promote the use of patient-reported outcomes (PROs) for HIV-infected patients in clinical settings by developing and commercializing a comprehensive, practical and integrated system for PROs management with crossdiscipline efforts.

In Phase I, we successfully implemented and pilot-tested an IRT-based adaptive PROs assessment engine supporting secure access from both web and phones. Patient and physician surveys showed strong support for our system usability and usefulness, providing early evidence of the commercial viability of our product.

Based on our original long-term goals and the lessons learned from the Phase I effort, our specific Phase II aims are to: 1) allow the PROsIT System be accessible from Tablet PCs and PDAs; 2) build an HIV-focused item bank; 3) add multi-lingual support to the PROsIT System; 4) assess the value and the practicality of using the PROsIT System in clinical practice; and 5) publish our study results in peer-reviewed journals.

The end result of this project will be a generic multi-platform, multi-lingual adaptive survey system and an HIV-focused item bank that could help promote the use of PROs in routine clinical setting. The study results will also further the understanding of the value of PROs in improving patient care.

Despite the abundant research in patient-reported outcomes (PRO) for cancer, PRO data are not routinely collected and utilized at oncology clinics due to technological and logistical constraints and lack of knowledge in interpreting, monitoring and responding to such data. Our long-term goal is to integrate patient-reported outcomes information, clinically relevant information, evidence-based medicine, and technology and methodology to provide on-demand and individualized clinical guidelines and treatment decision trees to improve cancer patients' care.

Our Phase I project aims are to (1) conduct focus groups, interviews and site visits to collect system functional and operational requirements; (2) perform literature reviews to assess scientific and technical feasibility; (3) create system design specifications; (4) develop and pilot test a prototype system; and (5) construct the initial PRO item bank focusing on breast cancer.

The proposed PRO management system is designed for both oncology clinicians and patients. The novelties are in the integration of well-developed psychometrics and advanced information technologies for daily practice and research application in clinical settings. With existing and increasing numbers of cancer patients in the U.S., the need for such an integrated system that we propose to develop is substantial.

The long-term goal of this project is to build a breast cancer-specific patient-reported outcomes (PRO) system that can be integrated into clinical practice and provides clinically relevant analyses and recommendations to clinicians and patients. During our Phase I project, we have produced functional and operational requirements, a working prototype, design and planning documentations, and a pool of breast cancerspecific PRO items.

Our Phase II project aims are to 1) complete system implementation and further refine the system based on user feedback; 2) deploy and test the system in real clinical settings; 3) incorporate PROMIS adaptive PRO instruments into our system with a standardized approach; 4) implement standards-based integration solutions to exchange PRO assessment results with other EMR systems; 5) evaluate benefits of using this system in clinical practice; 6) create user manuals and tutorials; and 7) publish study results in peer-reviewed journals.

This is a novel cancer-specific PRO application addressing issues hindering the utilization of PRO in clinical practice using well-developed methodology and advanced technology. With existing and increasing numbers of cancer patients in the U.S., the need for such an integrated system that we propose to develop is substantial. This project could also further our understanding and knowledge of the value of PRO for cancer patient care, so that better treatment decisions can be made and resources be better allocated.

The long-term objective of this study is to increases access to care, empowers patient self-management and ultimately delivers better patient outcomes by uniting telemedicine technologies, patient-reported outcomes research and dialogue-based patient-provider communication. The technical objectives for this Phase I proposal are 1) develop a home-centered coordinated cancer care (HC4) model and 2) develop and evaluate a working prototype of a tracking system to monitor and facilitate the delivery of care as specified in the HC4 model.

The HC4 model will be defined from various perspectives including organization, procedure, assessment, clinical and technology. Our approach includes systematic literature review and iterative refinement of the model through discussions and interviews with physicians, nurses, patients and caregivers. The prototype system will be developed following standard object-oriented analysis and design process. Focus groups will be convened to discuss model and system design options. Several controlled pilot test runs will be conducted to gain preliminary evaluation of system design in terms of interface usability and clinical usefulness.

It is expected that Phase I results will validate the feasibility of the proposed system from the perspectives of both practicality and technology for the purpose of Phase II execution and ultimate commercialization.

The goal of this specific project is to develop a cost-effective proactive telenursing system for the management of chemotherapy side effects. Patients will use this system to report health status on a daily basis during treatment, either on the Web or via interactive voice response system over the phone. Depending on the reported severity, the system may deliver just-in-time, evidence-based, context-sensitive patient education materials tailored to the patient's disease status and treatment regimen, and/or alert the oncology clinical care team to provide timely remote monitoring and consultation.

Our Phase I aims are to (1) design a telenursing model with the special focus on tailored patient instructions via systematic literature review, web resource review, focus group discussions, and personal interviews; and (2) develop a working prototype based on the resultant telenursing model and conduct controlled pilot study in realistic settings to evaluate technical feasibility, the acceptance level by providers and patients, and the effects on clinical outcomes and perceived intervention effectiveness. The initial focus of the Phase I feasibility study is on neutropenia, fatigue and nausea, three of the common chemotherapy side effects, for lymphoma patients and will be extended to other side effects and cancer sites in Phase II.

This project is consistent with our long-term strategic direction to improve access to care, promote patient self management, facilitate provider-patient communication, and ultimately improve clinical outcomes and reduce healthcare costs with multidisciplinary approaches integrating telehealth and e-health technologies, evidence-based medicine, patient-reported outcomes methodologies, and patient education research.

The long-term goal of this study is to facilitate early colorectal cancer (CRC) detection by developing a care coordination system that will facilitate both screening and diagnostic processes via e-health, telemedicine, clinical decision support, patientreported risk information, patient education, and coordinated care models and technologies. Specifically, we seek to 1) provide alerts to health care providers (HCP) to help them track CRC screening/diagnosis referrals for persons at normal risk and due for screening, and for those at greater risk due to family history or specific signs/symptoms; 2) present just-in-time, individually tailored education instructions to patients based on PRO data; 3) coordinate care team tasks with EMR/telemedicine integration; and 4) coordinate assistance from all support resources, including community health advisors.

This approach is especially important for the Latino population along the US-Mexico border in Arizona, who are often seen in Federally Qualified Healthcare Clinics (FQHCs). The technical objectives for this Phase I proposal are to 1) develop the CRCspecific screening and diagnostic care coordination model via literature review, focus groups, interviews, and a retrospective medical record review of CRC patients; 2) develop a web-based prototype system to facilitate the execution of the CRC screening and diagnosis model; and 3) evaluate the prototype in terms of usability and usefulness.

Our long-term objective is to develop a computer system facilitating the use of patientreported outcomes (PRO) information to monitor patient status and assist clinical decision-making for cancer patients under palliative and \ hospice care. This system will integrate PRO and other clinical data with evidence-based treatment guidelines and pathways to care and interface with and foster collaborative decision-making between the patient, the caregivers, and the medical care team.

This project will leverage the BrightOutcome architecture for PRO management developed in our other SBIR efforts, already implementing CAT/IRT capability, multiple delivery platforms, graphical reports highlighting clinically meaningful PRO score changes, and alert/reminder mechanism.

Considering the project goals and our past and current R&D efforts, we define the specific Phase I technical objectives as follows: 1) Define a palliative/hospice care model to integrate PRO assessment results with evidence-based pathways to care to provide clinical decision support for clinicians and education opportunities for patients and caregiver via literature review, focus groups, and interviews; 2) Design a system architecture facilitating the sharing and transfer of PRO related medical data between cancer clinics, hospices, and patients' homes; 3) Develop a working prototype following object-oriented and knowledge-based software development methodologies; and 4) Evaluate the usability and usefulness of the prototype solution via controlled pilot tests.

It is expected that Phase I results will validate the feasibility of the proposed solution from the perspectives of both practicality and technology for the purpose of Phase II execution and ultimate commercialization.

There is a growing recognition of the importance of subjective patient-reported outcomes (PRO) in patient care. Several recent studies have observed positive impacts of routine use of PRO assessments in clinical practice, reporting improved physical, functional and emotional well-being, reduced hospitalization, better detections of less observable and subjective PRO concerns, and better patient-provider communication. Recognizing the value and potential of PRO assessments, the NIH is completing a 5- year $25MM Roadmap Initiative, called the Patient Reported Outcomes Management Information System (PROMIS), and in the process of funding the second round of PROMIS research activities. The goal of the PROMIS Initiative is to develop and validate a new set of standardized PRO instruments based on modern computerized adaptive testing (CAT) and item response theory (IRT). A primary benefit, amongst many others, of CAT/IRT-based instruments is that they are dynamically administered, tailored to each individual's past responses, and hence much shorter (i.e., fewer items) but without sacrificing measurement precision.

Parallel to the PROMIS endeavor, enormous interests exist within both the government and the private industry in developing interoperability standards to facilitate data exchange between heterogeneous healthcare information systems; in particular the government's Health Information Technology (HIT) Initiative that heavily leverages existing industry standards. Standardization efforts for the clinical research community are also in progress; most notably by the Clinical Data Interchange Standards Consortium (CDISC). The promotion of electronic medical records (EMR) system by the Administration as part of the healthcare reform effort furthers the cause of data standardization.

Ideally, the vast investment on EMR and data standardization and on PRO-related research such as the PROMIS project should bring the goal of wide adoption of PRO in clinical research and practice closer to fruition. Unfortunately a major gap still exists to prevent this goal from being achieved, namely the lack of data standardization for PRO instruments and assessment results. There has been no concerted effort to bring the PRO community into any data standardization endeavors. This project thus intends to bridge this gap between the PROMIS Initiative and various standardization initiatives so that the benefits of the PROMIS project and the field of outcomes research in general can be fully realized.

Specifically, this project seeks to a) establish interoperability data standards for patient-reported outcomes (PRO) instruments and assessment results, including both the conventional static PRO questionnaires and the new adaptive item banks from the NIH PROMIS project; and b) develop interoperability reference implementations of these standards demonstrating integration scenarios with open-sourced electronic medical record (EMR) and clinical trial management (CTM) systems.

Building on top of our success in developing coordinated cancer care systems for patients either during active treatment or during screening/diagnosis processes, we are proposing in this project to focus on helping post diagnosis patients, with a special focus on the period between the diagnosis of ovarian cancer and the start of the treatment. Although this period is relatively short, it is one of the most agonizing, terrifying, and confusing period for cancer patients and their families to deal with. Communication at all levels is needed to help patients understand the disease and the treatment options and understand when and how to ask for help. Clinicians also need communication help to understand the patient's health-related priorities, beliefs, and emotional states to aid clinical decision-making.

From a patient-centered communication perspective, this project will address the topics of fostering healing relationships, exchanging information, responding to emotions, managing uncertainty, making decisions, and enabling patient selfmanagement to various degrees. One novelty of this project is the use of video clips as a major communication media. Videos produced in the local clinic setting showing the providers that patients will interface with can put a more personal touch on the information to be conveyed to patients and could be more effective.

The technical objectives for this Phase I proposal are to 1) develop an ovarian cancerspecific care model (including video scripts) for the period between diagnosis and treatment via literature review, focus groups, and interviews; 2) develop a prototype system (including video production) to deliver this care model and 3) evaluate the prototype in terms of usability and usefulness via pilot test.

Cancer symptoms due to disease progression or side effects caused by cancer treatment are prevalent.  Most cancer patients are treated in outpatient settings. Patients may be provided with patient education materials and counseled on anticipated side effects while being provided with different self-management options and warnings regarding when medical care is required. Despite these efforts, many people feel set adrift in having to self-manage treatment and illness related symptoms at home resulting in a sense of burden for the patient and the caregiver, in suboptimal patient reported outcomes (PROs) and in increased healthcare costs due to unnecessary hospitalizations or clinic visits. 

The overarching goal of this project is to develop a home-based Cancer Symptom Management Model (CSMM) to promote patient self-management of cancer-related and treatment-related symptoms by facilitating remote management by the clinical care team.  The anticipated benefits include improved patient self-reported outcomes, self-efficacy, patient-provider communication, and appropriate utilization of hospital and clinic care.

This work originated from a Phase I SBIR Contract project (HHSN261200700055C) with a similar overall goal of developing a home-based symptom self-management solution with breast cancer patients who used the system to report perceived symptoms and their severity via an interactive internet or phone program.  The system employs a rule-based algorithm to evaluate the reported severity and determine whether to offer the patient self-management instructions and/or alert the clinical team to contact the patient for just in time tele-consultation. This multidisciplinary effort includes a team of experts in oncology, nursing, outcomes, telemedicine, psychology, communication, and computer.

Based on our successful experience and the interest in the system from patients with other malignancies as well as from other clinical providers, we built on our pilot data in breast cancer by expanding our study population to include all patients with cancer.

Specific aims are:
Aim 1: Collection and Analysis of System Requirements: conduct focus groups with patients, caregivers, oncologists, and nurses to review the prototype and identify and prioritize means to enhance content, usability and utility of the prototype.

Aim 2: Design and Development of a Working Prototype: implement user recommendations by modifying the prototype with an object-oriented and user-centric software development process that focuses on iterative design principles involving end-users early and frequently in the design process and begin to develop just in time patient education video clips to convey symptom self-management instruction.

Aim 3: System Usability and Usefulness Evaluation: pilot test the prototype in up to 60 cancer patients in a randomized controlled design. Pre-selected clinical outcomes, self-efficacy, communication, system satisfaction, as well as health system utilization patterns will be examined from both the patient/caregiver and the clinical team perspective.

MS affects an estimated 400,000 MS patients in the United States today 1. The estimated high socioeconomic burden of lifetime costs of more than US$2 million per individual 2 is associated with early onset of disease between the second and fourth decades without significant impact on life expectancy. MS leads to various combinations of motor, sensory, endurance and/or cognitive impairments, making self report challenging. The physical impairments limit ability of MS patients to use technology to effectively self-report health status and changes MS patients also often experience physical and/or mental fatigue and cognitive difficulties, such as increased distractibility, that cause additional issues for longer questionnaires. 

To address the needs of people with disabilities, such as those with Multiple Sclerosis. This project expanded the BrightOutcome domain from cancer to include the disability and rehabilitation populations and worked toward providing a comprehensive accessibility solution. The prototype developed in Phase I was based on our existing PRO management solution called 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, and 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. To address these accessibility concerns, our specific Phase I aims include:

Aim 1: Design and development of a PRO assessment interface. Based on a user-centered design process, we developed a system that facilitated self-reporting by MS patients with different physical and neurocognitive impairments using different technology platforms (web-enabled computers, touch-screen computers, speech-enabled computers, and phones).