UNMET NEEDS IN PRIMARY CARE

As the number of primary care providers diminishes and the need for primary care increases, the fundamental unmet need is to increase the capacity of providers to care for more patients without a decrease in the quality of care and without unduly burdening the providers. Two POC technology-enabled pathways towards this end are:

• To introduce point-of-care technologies that eliminate unnecessary steps and re-work to increase the efficiency of operations.
• To offload selected testing and self-monitoring capabilities to the home setting for patient self-management.

In 2013, the highest clinical priorities for point-of-care technologies to address unmet needs in primary care are:

• Clinical laboratory testing: in particular complete blood count (including WBC with differential; electrolytes (potassium of highest priority); lipid panel (cholesterol, LDL); renal function panel (BUN, creatinine, microalbumin); diabetes screening panel (HbA1c of highest priority; includes renal function panel).
• Infectious disease: Rapid differentiation between viral and bacterial infections and if bacterial, segmentation into either gram positive or gram negative bacteria.
• Anticoagulation testing: INR/PT

FREQUENTLY ASKED QUESTIONS

1. Who can apply for Point of Care Technology Research Center in Primary Care grants? In order to be eligible for the Innovation Award, proposals must include written institutional approval from an academic institution, medical center, or non-profit institution with 501c(3) status within the United States. Qualified small business entities may also apply. A small business has fewer than 500 employees and qualifies as a small business concern under 13CFR Part 121. Eligible Principal Investigators must hold a faculty appointment at an institution of higher education or medical center in the United States.
2. Are international laboratories outside of the United States eligible to participate? Unfortunately, the POCTRN awards are only currently available for laboratories in the United States.
3. When are applications due? Pre-proposals are due by 11:59pm EST Monday, April 8th, 2013. Full proposals are due by 11:59pm EST Monday, July 1st, 2013.
4. How much funding is available? Do you give multi-year Grants? Applicants may request up to $100,000 direct cost per project. Indirect costs are provided at the performance sites' Federally-negotiated rates up to 74%. Currently, only one year applications are accepted.
5. Where do I submit my pre-proposal? All pre-proposal information must be submitted through the on-line submission system at https://cimitconnect.induct.no
6. When will I be notified if my Pre-proposal has been selected to submit a Full Proposal? All Pre-proposal applicants will be notified on or before Monday, May 6th, 2013 whether or not they have been selected to advance to the Full Proposals phase.
7. My pre-proposal was accepted and I have been invited to submit a full proposal. Now what? If you are invited to submit a full proposal, it must be submitted through the on-line submission system no later than 11:59pm EST Monday, July 1st, 2013. Follow the step-by-step instructions on the web-based submission site. The files do not need to be loaded all at once. The PI may log on as many times as he or she wishes until the deadline.
8. Where and how do I submit my full proposal? All full proposal information must be submitted through the CIMIT proposal submission system at https://cimitconnect.induct.no. Instructions will be provided on the website. No material can be submitted directly to CIMIT staff.
9. Who reviews the applications? The Review Panels are made up of practicing clinical specialists, engineers and scientists with broad experience in medical innovation. Full proposal applicants can suggest reviewers, though no assurance is given that suggested reviewers will be utilized. Applicants can also provide names of potential reviewers who they would prefer not be used, and every effort will be made to accommodate these requests. These requests should be included in a letter uploaded with the other supporting documents.
10. Is there anything "special" that applicants should know? Key elements of a strong application are collaboration and innovation. Work between investigators in different institutions, and among clinicians, scientists and engineers who might not normally work together is encouraged. The Team section of your proposal should make this explicit.
11. Who retains the rights to any intellectual property generated by a proposal? Management of intellectual property will be determined by the institutional policies of the entity responsible for the proposal.
12. Should I disclose any unprotected proprietary information in the submission? Protecting proprietary information is the responsibility of the applicant and the applicant institution. Consistent with NIH policy, applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, when the application contains information that constitutes trade secrets, or information that is commercial or financial, or information that is confidential or privileged, identify the pages in the application that contain this information by marking those paragraphs or lines with an asterisk (*) at the beginning of the paragraph. Indicate at the beginning of the Research Plan which pages contain asterisks and a note stating: "The following sections marked with an asterisk contain proprietary/privileged information that [name of applicant] requests not be released to persons outside the Government, except for purposes of review and evaluation." When information in the application constitutes trade secrets or information that is commercial or financial, or information that is confidential or privileged, it is furnished to the Government in confidence with the understanding that the information shall be used or disclosed only for evaluation of this application. If a grant is awarded as a result of or in connection with the submission of this application, the Government shall have the right to use or disclose the information to the extent authorized by law.
13. Who should I list as collaborators? List only individuals who are considered key personnel or significant contributors to the work that will be performed, and who have agreed to their role. Avoid honorific collaborations.
14. I am writing a pre-proposal. May I include several references? You can include as many references as you would like, but they must be included in the two-page limit.
15. Should I submit copies of relevant publications? Please do not submit copies of relevant publications. Standard citation of publications is acceptable.
16. Will you accept a video showing how my system works? Videos will not be accepted.
17. What is an institutional sign off page? It is the official sheet from your research administration office indicating that your full proposal is approved by your institution. Be sure to ask your research administration office how much lead time they need to process this form in the event you are invited to submit a full proposal so that you can submit all your documents before the deadline. Signature from an authorized business official must be received prior to the proposal deadline.
18. Are there any budget restrictions or limitations? Equipment must be well justified to the purpose and exclusive need of the project. Alterations and renovations will not be supported.
19. Are indirect costs provided? Indirect costs will be provided at your institution‘s Federally-negotiated rate up to 74%. If your institution does not have a Federally-negotiated rate, indirect costs may be provided up to 25% provided that the costs are well documented in your budget justification.
20. When would I receive my funding? The timeliness of your revisions to the administrative materials, should any be needed, and any necessary protocol approvals, will affect when you receive your award, which would not be sooner than October 1, 2013. If your work involves human subjects, data or tissue derived, or live animals, the necessary IRB and IACUC approvals must be received by CIMIT prior to the activation of your award. In addition, Federal funds provide the support for 2013 awards and must be received by CIMIT prior to the release of your award.
21. What are my reporting responsibilities if I receive an award? An annual report is required to be submitted by investigators in accordance with the terms and conditions of the award. Quarterly reports will be required to facilitate progress and integration with the overall POCTRC-PC program.
22. How is primary care defined? Primary care is “frontline medicine,” and is typically delivered by internists, pediatricians, family practitioners and nurse practitioners. It is usually found in a clinic-based setting. A multi-disciplinary team-based approach to primary care can also include physicians, nurse practitioners, nutritionists, physical therapists and other professionals, collaborating in managing patient-care issues. Note that primary care is increasingly delivered via outreach to the home, workplace, satellite clinics and/or community settings – not just in the traditional “physician‘s office” setting. Increased access and convenience are sought in this evolution, and innovative technology can play a significant role in accelerating desired changes in practice patterns.
23. Does the POCTRC-PC support software development? POCTRC-PC reviewers will distinguish between routine software engineering (data processing, interfacing, simple signal processing), and research software in which new algorithmic approaches are required to solve a clinical problem. Like any other task, software engineering may be supported when it is necessary to meet project objectives. Research software projects must be approached in the context of a clinical purpose or care pathway, and the project must involve direct collaboration with a physician.
    
    The POCTRCPC does not support classic Information Technology projects (electronic patient record, data mining for decision support, etc.) because institutions and industry groups are already investing significant resources in these areas.
24. Does POCTRCPC fund clinical trials? No, based on the definition of a clinical trial as patient-oriented research in which the data is gathered for possible presentation to the FDA. We do support earlier stage feasibility or proof-of-principle efforts that involve human subjects.
25. What are the general design characteristics for point of care technologies in primary care? The general design features for an ideal POCT device for use in a primary care setting are described below. Although device design should incorporate as many of these features as possible, it is recognized that technology restraints may preclude incorporation of some of these features.
    Device Footprint: POCT devices should be designed to have as small a footprint as possible. Small bench top or handheld devices are optimal.
    Analytical Performance: POCT devices for use in a primary care setting may produce either quantitative or qualitative results. In the vast majority of cases the same tests are offered on more automated instrument platforms in the central clinical laboratory. As a general rule, the point of care devices should perform equally to central laboratory instruments with regard to analytical accuracy, reportable range and imprecision. Exceptions where lesser degrees of analytical performance may be acceptable include devices designed as screening tests ( to be followed up by confirmation in a central laboratory), devices for monitoring a changing status in a patient or devices that produce unique test results that are not available in the central laboratory. Analytical time should be kept to a minimum (less than 5 minutes for common chemistry analytes and less than 15 minutes for immunoassays).
    Information connectivity: All instrumented POCT devices should be capable of being interfaced directly to the electronic medical record system. Several companies offer open architecture POCT data management systems designed for this purpose. Industry standards specifying the appropriate connectivity architecture have been developed and are available from the Clinical Laboratory Standards Institute. The ability to transmit data using a bidirectional wireless interface is most optimal.
    Ease-of-Use: Ease-of-use is essential to successful implementation of POCT test devices. In the case of instrumented devices the user interface with the device should be designed to ensure regulatory compliance under the clinical laboratory improvement amendment (CLIA-88) with minimal requirements for intervention by the operator. Results readout must not be subjective but easy to read using color change readout, digital or graphic formats. The use of required fields including operator identification, patient identification, date and time of the test, confirmation that quality control has been performed and confirmation that reagents are within their expiration date should be embedded in the user interface. The use of barcode scanners, RFID chips and touch screen technology should be employed to facilitate data transfer and to ensure accuracy of the information entered. Ideally the device would be interfaced to the institutional ADT system to cross check accuracy.
    Sample types: Whole blood or other unprocessed samples are the most optimal choices for POCT. The use of serum or plasma that must be processed before analysis is to be avoided. Ideally instruments can perform primary tube sampling without the need for de-capping and pipeting samples. Where possible samples that do not require a trained phlebotomist should be used such as capillary finger-stick whole blood or saliva.
    Reducing Operator errors: The device should have built in software safeguards to ensure proper operation and reduce common errors such as lock-out of untrained operators, lock-out for failed quality control (or failure to perform quality control) and lock-out of expired reagents. Some devices can be designed such that quality control is performed automatically by the instrument including electronic and built-in liquid quality control as required. The device software ensures that the quality control values are within acceptable range before testing can be performed.
    Storage of Consumables: All consumables including reagents, calibrators and quality control materials should be able to be stored at room temperature. The shelf life should be minimally 6 months to 1 year.
    

WHAT IS PRIMARY CARE?

Primary care describes the activity of a health care provider who acts as a first point of consultation for all patients. Continuity of care is also a key characteristic of primary care. Primary care involves the widest scope of health care including all ages of patients, patients of all socioeconomic and geographic origins, patients seeking to maintain optimal health, patients with acute conditions, and patients with chronic diseases. Common chronic illnesses include hypertension, diabetes mellitus, COPD, depression and back pain.

Primary care professionals seek to provide health promotion, disease prevention, health maintenance, counseling, patient education, diagnosis and treatment of acute and chronic illnesses in a variety of health care settings including office, inpatient, critical care, long-term care, home care, day care, senior center, and clinic.