Find Funding

Contract Topics

246 Integrating Patient-Reported Outcomes in Hospice and Palliative Care Practices

Number of anticipated awards: 3
(Fast-Track proposals will not be accepted.)
Budget (total costs): Phase I: $150,000;
Phase II: $1,000,000
Project duration: Phase I: 9 months;
Phase II: 2.5 years

The deadline for receipt of all contract proposals submitted in response to this solicitation is: 5:00 p.m. Eastern Standard Time Monday, November 5, 2007

Numerous reports have identified the need to improve the management of symptoms and health-related quality of-life (HRQOL) problems in cancer patients whether these problems are related to treatment or the course of disease. This need is particularly great for cancer patients who suffer from pain and other significant symptoms, or who are at the end of life. Cancer patients falling into these categories, furthermore, are often and increasingly cared for not exclusively by oncology specialists, but by health care professionals specializing in hospice and palliative medicine. This presents both promises and challenges for pain and symptom management, since it adds to the number, complexity, and settings of the interactions between patients and various health care providers. Effective collection and communication of data on patients' symptoms and deficits in HRQOL becomes an even more critical challenge in such a system. For example, the fact that most of the care delivered by hospices to dying patients occurs in their homes, heightens the need for effective ways to assess symptoms and to make such data available to health care providers in a timely manner.

Addressing this issue, the short-term goal of this project requires the offeror to develop integrated, ongoing patient-reported outcome (PRO) assessment methods to provide timely, efficient, individualized information for monitoring patient progress and improving decision making in the hospice and palliative care setting. The long-term goal is to develop computerized PRO data measurement and information systems for use by clinicians and patients. Such systems would measure cancer-specific symptoms and HRQOL domains using well-validated instruments as well as methodologies such as item banking and computer adaptive testing administration, in order to gather patient-reported data for use in clinical practice. The systems would also ideally provide decision support for clinicians, and be integrated with electronic health records across various health care providers (e.g., hospice and palliative care clinicians, oncologists) and settings (home, inpatient hospice, nursing home, clinic, hospital). The goal of this project is to develop a measurement and information system that specifically addresses the unique challenges raised in pain and symptom management and the care of dying patients, and meets the needs of health care professionals in various settings where hospice and palliative care patients receive care.

Such systems are intended to facilitate collection of information from patients via alternative assessment media platforms, such as telephones, computers, handheld devices, and the Internet at selected or patient-determined intervals (not only at the time of a patient visit). Health status reports for both patients and clinicians need to be screened for urgency and tailored to their preferences and knowledge in a standardized format that can be integrated with medical records data, evidence-based guidelines, and resources for responding to patient needs. Data collection that meets privacy and confidentiality concerns will be used not only for patient care, but also to develop norms for clinician use and for research.

The systematic use of PRO information to guide care is accepted by clinicians in theory but does not occur in routine oncology practice in the U.S. (Donaldson, M.S., 'Taking Stock of Health-Related Quality of Life Measurement in Oncology Practice in the United States,' 2004, JNCI). Although much methodological instrument development has occurred, and feasibility studies collecting data in conjunction with the patient visit have shown improved patient-clinician communication, many challenges to widespread adoption still exist. These challenges include general clinician belief that instruments are not adapted for efficient use at the individual (rather than clinical trial) level. The use of HRQOL in routine practice requires acceptance by clinicians, patients, and administrators, timely communication among all who provide care, efficient data collection, analysis, and reporting and resources for responding to identified patient problems. For patients, it will require addressing the acceptability of PRO assessment in light of response burden and possible concerns about confidentiality. Importantly, patients will expect that data they provide will help to improve their care. The way forward, however, does not lie simply in adding PRO measurement to other clinician tasks such as the occasional, time-limited patient visit. Rather, effective implementation will require new information infrastructures and technologies to embed the timely, routine use of PRO information in the care process. In particular, a key objective is to uncouple outcomes measurement from the strictures of the patient visit-an opportunity provided by information technologies.

The rapid deployment and public acceptance of information technologies and networks offer an opportunity for developers to incorporate information about patient functioning with clinical records. Such systems would provide as-needed reports to patients and treating clinicians to assist in informed decision-making to improve health care. Health status reports can be tailored to the preferences and knowledge of the patient and clinician and may include graphical display of health status over time as well as identifying the need for clinical attention. Clinicians may wish to respond by e-mail, phone, or other means, rather than by patient visit only. Such tracking may help patients become more involved with their own care as do dieters who keep food records. This may also serve as a useful aid for caregivers to have a systematic and standardized way to monitor their loved ones health status and convey this information to the healthcare providers.

The NIH RoadMap initiative to develop the Patient-Reported Outcomes Measurement Information System (PROMIS) is in the process of developing item banks to capture a range of symptoms (e.g., pain, fatigue, depression, sleep/wake function) and HRQOL (e.g., physical function) for a broad range of chronic diseases (http://www.NIHpromis.org/). The PROMIS may serve as a valuable source for standardized measures, however there may be domains not captured by the system that are of importance in palliative and end-of-life care settings. There is need to act now to work with patients and hospice and palliative medicine clinicians to develop and test integrated information systems that focus on pain and symptom management and end-of-life care, and implementation in hospice and palliative care settings so that products like the PROMIS initiative can be successfully incorporated into practice. Such systems could then be disseminated into larger practice settings (e.g., general oncology) in which pain and symptom management are critical but provided by a broader variety of clinicians in diverse practice settings.

The ideal system should be adaptable to integrate with other data systems and be platform-independent (work across Windows, Mac, Unix, and other operating systems). PRO administration should be device independent, allowing patients to self-report via devices such as telephone, Internet, or handhelds. A flexible self-report system gives patients the freedom to choose a device that meets their preferences, schedule, or limitations. Opportunities for proxy report by caregivers when the patient is too ill to respond should be considered.

PRO data can be integrated with clinical information and reports tailored to user preferences, to serve a variety of key clinical functions. For hospice and palliative care clinicians, the report can profile patient functioning over time with clinically meaningful changes in health status highlighted for their attention. Such reports can include links to clinical practice guidelines and treatment recommendations adapted for the individual patient, local practice, and available resources. More active forms of clinical decision support may also be integrated within these systems-e.g., through use of care algorithms or care quality measures that utilize clinical data captured on individual patients. The PRO data collection system may be used to facilitate communication between different members of the health care team (e.g., various physicians, nurses, allied professionals). Data may also be used to provide feedback for patients in the form of reports that can be displayed in a format that is easily understandable for them to monitor their own progress and to indicate when they may need immediate care. De-identified PRO and clinical data could foster a better understanding of patterns of care and treatment effectiveness as well as to track changes in special populations and across tumor sites. Further, data could be used to update the data collection instruments to improve questionnaire properties and for clinical research.

NOTE: The National Cancer Institute (NCI) promotes the use of state-of-the-art media technology to develop tools, interventions, programs and systems that 1) are needed by professionals or the public to reduce cancer risk or improve the quality of life of cancer survivors; 2) help fill gaps in research; 3) resolve barriers to use so that products can be used effectively in medical and community settings; and 4) improve communication behaviors between primary care professionals and patients/care-givers in cancer-related matters.

Phase I activities and expected deliverables:

  • Conduct interviews, focus groups, clinical site visits and meetings among patients, clinicians, hospice and palliative care personnel, and information technology and PRO experts to identify local needs and formulate an approach to developing and implementing a PRO assessment system.
  • Perform literature reviews to determine the scientific and technical feasibility of creating and implementing such systems in practice settings, focusing on various key components of these systems (e.g., PRO assessment media, PRO assessment methodology, electronic health record infrastructure, provider communication media and systems, clinical decision support systems);
  • Provide a report detailing the program design and specification including a plan to integrate the PRO information system into a network of clinical practices;
  • Develop a working prototype of the PRO data monitoring, collection, and reporting infrastructure;
  • Include in the proposal, letters of agreement from organizations participating in Phase I feasibility testing and evaluation.
  • Obtain letters from interested participants for Phase II testing and evaluation.
  • Present Phase I findings and demonstrate the final prototype to an NCI Evaluation Panel.

NOTE: Offerors are required to fully develop their individual product in Phase II to meet the goals of this SBIR contract topic. Where feasible and appropriate, Phase II contractors may be required to collaborate, coordinate, or communicate with other NCI funded contractors or programs. Offerors are also required to develop a dissemination package that enhances marketability.

Phase II activities and expected deliverables:

  • Develop and integrate the information systems in clinical practices, focusing on key components.
  • Create evaluation measures.
  • Evaluate and refine the program based on user feedback.
  • Create a manual, tutorial, and other educational materials designed to integrate this system in other clinical practices including cancer centers and community care settings-addressing both technical implementation and social/cultural change management.
  • Developed software to run the system and track outcomes.
  • In the first year of the contract, provide the program and contract officers with a letter of commercial interest.
  • In the second year of the contract, provide the program and contract officers with a letter of commercial commitment.
  • Include $24,000 in the budget for evaluation of the product at NCI's Evaluation Lab.
  • Present final research findings and demonstrate the final product at an NCI/DCCPS sponsored Product Showcase.
  • Prepare at least one manuscript describing the development and evaluation of the product for publication in a peer-reviewed scientific journal.
  • Submit final report in the template provided by the NCI program officer.

[Back to Contract Topics]