Objective: Annual national competition to develop point-of-care technologies to address unmet needs in primary care. Of particular interest are solutions for rapid office-based testing that would enable early disease detection and timely intervention eliminating unnecessary steps and re-work and technologies that would enable self-testing and self-monitoring in the home for patient self-management.
Eligibility: Open to academic, engineering, research and development laboratories in the United States. Qualified small businesses may also apply. We encourage collaboration with investigators within the CIMIT consortium.
2016 Application process:
POCTRC Award applications are solicited and evaluated in two stages. Applicants may submit pre-proposals which will undergo review. A subset of the applicants who submitted pre-proposals will be invited to submit full proposals.
Documents and Instructions for the pre-proposal phase can be found on the POCTRN website:
Additional documents for the full proposal phase include:
|February 1, 2016||Pre-proposal Submission Site Will Open|
|March 7, 2016||Deadline for Pre-proposals Submissions|
|March 21, 2016||Full Proposals Invited|
|May 9, 2016||Deadline for Full Proposals|
|September 1, 2016||Award Finalists Notified|
To view a description of unmet needs in primary care, read the answers to frequently asked questions, and see a list of previous awardees, click on the corresponding tab below. For further questions and assistance, please email Penny Carleton, at CIMITGrants@partners.org.
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 ability of providers to care for more patients without decreasing the quality of care given and without unduly burdening the providers, patients or their families.
In general, two POC technology-enabled pathways to increase primary care capacity are:
On an annual basis, in collaboration with the MGH Stoeckle Center for Primary Care Innovation, under the leadership of Susan Edgman-Levitan, unmet clinical needs in primary care where technology-enabled solutions could be of benefit will be defined and prioritized.
The 2016 national call is for breakthrough, disruptive innovations that transform the quality, efficiency, and/or patient /provider experience in the clinic or in the home while reducing the cost of care./p>
The POCTRC in primary care is receptive to proposals from industry applicants with pre-commercial or commercially available devices that have not been optimized for primary care. The application must detail the limitations of the currently available systems relative to use in primary care and describe how the proposed approach overcomes these limitations.
Preference will be given to late stage development efforts where the innovation is likely to be introduced into clinical practive within 18-24 months.
Primary care is the foundation of our health care system.
The Institute of Medicine provided this definition in 1996: "Primary care is the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community."
Primary care providers serve as the first point of contact for patients regarding preventive care, for minor illness or injury and, increasingly, for serious chronic diseases and complex co-morbidities. They initiate referrals to specialists and coordinate care across multiple specialties.
Primary care professionals 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.
Patients and families can choose a family physician, general internist, pediatrician, or medicine-pediatrics doctor to be their primary care physician. Nurse practitioners and physician assistants work closely with these physicians to also deliver primary care. Primary care is the patient’s entry into the health care system and the medical “home” for ongoing, personalized care.
Some people think that primary care physicians only handle simple things: making sure kids get their vaccinations, treating sore throats and bladder infections, and doing school and annual physicals. However, the truth is quite different: primary care physicians need a vast amount of medical knowledge because they care for patients with hundreds of different problems including high blood pressure, elevated cholesterol, liver disease, back pain, memory loss, developmental and behavioral problems, depression, heart disease, asthma, obesity, and more.
Primary care physicians also coordinate the care of their patients throughout the confusing health care system; for example, arranging for patients to get an MRI, choosing the right specialists, helping the elderly find their way through the pharmacy maze of Medicare Part D, and checking up on home nursing services. In addition, primary care physicians are a trusted source of information, helping their patients choose the best options and manage conflicting recommendations from specialists and other physicians.
It has repeatedly been demonstrated that health systems built on a strong primary care foundation are associated with improved quality, decreased mortality, and reduced costs (Shi 2003; Starfield 2005; Lewin 2008; Starfield 2005). Patients who are connected to a primary care provider receive more guideline-consistent, high-quality, care than those who are not (Atlas 2009).
Primary care reduces the out-of-control growth of health care spending. When more primary care physicians, per person, are practicing in a community, hospitalization rates are lower (Parchman 1994). In addition, states with more primary care physicians who care for Medicare patients have lower Medicare costs and higher quality of care; states with fewer of those primary care physicians have higher costs and lower quality (Baicker 2004).
Primary care improves the quality of care for people with many different illnesses. Children and adults with primary care physicians are more likely to receive recommended preventive services, to have better management of chronic illnesses, and to be satisfied with their care (Bindman 1996; Safran 1998; Stewart 1997). States with more primary care physicians per capita have lower total mortality rates, lower heart disease and cancer mortality rates, and higher life expectancy at birth compared with states having fewer primary care physicians (adjusting for other factors such as age and per capita income (Starfield 1998).
Unfortunately, leveraging these clear population and systemic benefits of a strong primary care foundation is out of reach because primary care in the United States today is in a state of crisis (Bodenheimer 2009).
There are very real threats to primary care’s survival. In 2006, the American College of Physicians, an organization representing both primary care physicians and specialists, warned that, “Primary care, the backbone of the nation’s health care system, is at grave risk of collapse‚Ä¶.” (American College of Physicians 2006).
Just as the demand for care is increasing with an aging population (the number of Americans over 65 will double by 2030), the pool of primary care providers is shrinking (Thorpe 2006a; Thorpe 2006b). Few medical students choose primary care and many older primary care physicians are retiring early (Lipner 2006). In fact, from 1997 to 2005, the number of US medical school graduates entering family medicine residencies dropped by 50 percent (Pugno 2005). The combination of lower incomes and a stressful work-life discourages medical students and young physicians from choosing primary care careers. These trends are fueling projections of a primary care shortage of 40,000 by 2020 (RWJ 2011), and up to 65,000 by more recent estimates that incorporate the impact of the Affordable Care Act. This imbalance in supply and demand constrains primary care capacity, limiting access and fragmenting care as patients and families seek out other points of entry, often more expensive and less interconnected (such as emergency departments), into the health care system.
Forty-two percent of primary care physicians report not having enough time to spend with their patients (Center for Studying Health System Change). That frustration is made worse by a payment system that is unfair to primary care. For example, a specialist spending 30 minutes performing a surgical procedure, a diagnostic test like a colonoscopy, or an imaging study like an MRI, is often paid three times as much as a 30-minute primary care visit with a complicated patient who has diabetes, heart failure, headache, and high cholesterol (Bodenheimer 2006).
Estimates suggest that patients receive no more than 50% of recommended acute, chronic, and preventive care (Asch 2006). In addition, 60 million Americans, nearly one in five, lack adequate access to any primary care in their communities (National 2009).
Primary care practices tend to be very busy places that are challenged to meet the needs of a wide variety of patients, who present with one or more diagnoses (from a seemingly unlimited list), and who require care from across the spectrum of services ‚éĮfrom acute to chronic to preventive.
To meet patient demand, primary care is increasingly practiced by teams of clinical and non-clinical staff. In addition to the primary care physician and one or more nurses, teams may include a medical assistant, behavioral health practitioner, health coach, and others. This enables team members to work at the top of their licenses, and takes away tasks from physicians that others can perform. These tasks include checking vitals, but also extend to care for other issues, including chronic disease follow-up, and matters that non-physician team members can safely handle (Bodenheimer 2007).
Read more about building teams on the California HealthCare Foundation website: http://www.chcf.org/publications/2007/07/building-teams-in-primary-care-lessons-from-15-case-studies#ixzz2setdLrgq
For examples of how primary care practices are organized, please visit The Commonwealth Fund link provided below. The Commonwealth Fund sponsored case studies of 12 high-performing, patient-centered primary care practices in 2008. Practices were selected for study on the basis of their exceptional patient experience survey scores across multiple domains. The purpose of the case studies was to document models of high-quality, patient-centered care, and to extract lessons regarding the organizational factors and specific processes used by these practices to achieve favorable patient experiences.
Read more about these case studies on the Commonwealth Fund website:
http://www.commonwealthfund.org/Innovations/Case-Studies/2008/Aug/Grant-Community-Clinic--Case-Studies-of-Patient--and-Family-Centered-Primary-Care-Practices.aspx (additional cases listed in left margin on Commonwealth site)
Here are two definitions of PCMH:
PCMH patient brochure:
“Patient-centered” is a way of saying that the patient is the most important person in the health care system.
The National Committee for Quality Assurance recognizes practices functioning as medical homes through use of systematic, patient-centered, and coordinated care management processes. These practices are evaluated on whether or not they meet a series of Standards (the first of which is to “Enhance Access and Continuity”). It is in this emerging paradigm of primary care that point-of-care diagnostics can play an important role.
Imagine a primary care practice where rapid testing would eliminate unnecessary steps and re-work in the office, or where selected testing and self-monitoring capabilities would be available in the home for patient self-management.
Point-of-care (POC) technology is defined as medical testing at or near the site of patient care (office or home). Such technologies comprise inexpensive, convenient, and user-friendly medical devices and information-sharing tools that deliver trusted information to the clinician in real-time. This timeliness increases the likelihood that patient, physician, and care team can make immediate clinical management decisions, thus improving quality and patient safety.
A few examples of POC technologies currently in wide use are rapid strep tests, blood glucose monitoring, urine testing for pregnancy, and rapid flu testing.
Although numerous point-of-care technologies exist, very few are designed to address the unique needs and challenges of a primary care setting.
Emerging solutions to this crisis in the US are centered on expanding the capacity of primary care clinicians and practices to care for complex patients across the continuum of health and disease. The creation of activated, coordinated teams of providers with integrated POC testing that proactively re-orient care around the needs of the patient through the Patient-Centered Medical Home (PCMH) model are critical (Bitton 2010).
The introduction of point-of-care technologies into primary care would increase the capacity of practices to care for more patients by eliminating inefficient testing turnaround delays and the need for post-visit communication of results and recommendations to patients, freeing up clinical time.
It is estimated that 55% of a primary care physician’s day is spent outside of the examination room, primarily focused on follow-up and documentation of care for patients not physically present (Gottschalk, 2005). This administrative rework is not only time-consuming, but discontinuous care jeopardizes patient outcomes in that the start of effective therapy may be delayed or, even worse, abnormal results may not be communicated back to the primary care physician from the laboratory or to the patient by the PCP resulting in a serious “failure to diagnose” because of lack of follow-up.
Point-of-care diagnostic technologies are neither new nor unique. There is a substantial POC testing literature and a number of commercially available devices and systems (Kalorama 2011: Cunningham 2011; Price 2010). However, although there are a number of point-of-care diagnostics for acute care, the list is far shorter for primary care due to challenges unique to this setting, such as the expense associated with lower test volumes, training needs, higher quality control costs and associated regulatory burden, the need for decision support to interpret test results and rigorous requirements for operational reliability.
The average number of patients cared for by a single primary care physician is 2500 (Ostbye 2005); on a given day, a physician may see 15-25 patients. It is within this context that the true burden of inefficient testing systems and the potential value of POC diagnostic testing can be understood.
Time saved by employing POCT could be spent in direct patient care, thereby increasing capacity and improving access. Communication hand-offs and delays would also be reduced, thus improving patient safety and continuity of care.
In the absence of POCT, the downside for physicians is time lost in communicating with the laboratory and the family that could have been spent seeing other patients and the inability to ensure appropriate treatment at the time of the patient visit.
The downside for patients is the inconvenience in additional visits to central labs for testing prior to or after an appointment, delays in diagnosis and, in the case of infection, the potential for over-prescribing antibiotics resulting in the danger of antibiotic resistance.
The rapid strep test in pediatric offices benefits nearly every child under the age of six who is exposed to streptococcus. Since infection by group A streptococcus presents with non-specific symptoms of acute pharyngitis, it is important to differentiate strep infection from other causes (Lewandrowski, 2001).
If POCT testing confirms strep to be present, a physician writes an antibiotic prescription and a full course of treatment begins immediately.
However, if POCT is not available, the scenario is very different – time-consuming, expensive, with delayed results, and not patient-centered. 1) A throat culture is taken. 2) Culture is sent to the lab. 3) A 3-day course of antibiotic treatment may be initiated. 4) A prescription is given for the full course of treatment. 5) When lab results are ready, the physician receives the results and contacts the parent/ guardian. 6) If test results are negative, (the unneeded) antibiotic treatment ends. If results are positive, the prescription is filled for the full course of treatment.
The multi-step scenario described above (for testing without a POC diagnostic test) is repeated time and again in primary care offices, not just for infectious diseases, but for other acute and chronic illnesses dependent upon test results for reliable clinical decision-making.
The examples below illustrate the breadth and complexity of clinical scenarios encountered in primary care.
Example 1: Mrs. Gonzalez is an 80-year-old woman who has many active co-morbid illnesses that include diabetes, hypertension, cardiovascular disease, and an old myocardial infarction, which has left her with a left bundle branch block and Parkinson's disease. She comes in to clinic today with her daughter, because her daughter notes that she has been feeling lightheaded lately and been complaining of palpitations. On history, her daughter notes that her mother seems to have difficulty keeping track of her medications. Among her medications, she takes an oral hypoglycemic, an HMG CoA reductase inhibitor, an angiotensin-converting enzyme inhibitor, a diuretic, and L-dopa. An ECG is performed in the office. However, due to her left bundle branch block, it is uninterpretable except for rate.
Desirable POCTs: potassium, blood urea nitrogen, creatinine, CBC, echocardiogram, heart loop monitor, troponins
Example 2: Mr. Lee is a 20-year-old college student who is on his school's varsity basketball team. Over the last month, several of his teammates have developed rashes. He comes in today for evaluation of his rash. When he is examined, the rash appears to be scattered red bumps of varying sizes. Several have whitish centers; many are excoriated (ie, abraded).
Desirable POCTs: CBC, rapid scabies, MRSA, rapid fungus
Example 3: Mrs. Green is a 40-year-old woman who comes in to clinic with worsening abdominal pain both right and left lower quadrants, low-grade fever and diarrhea over the last five days. She returns recently from a business trip in Southeast Asia. She had been placed on prophylactic antibiotics and anti-malarial medications prior to travel. She was up to date on all her vaccinations. She has a family history of gallstone disease, as well as inflammatory bowel disease.
Desirable POCTs: CBC; electrolytes; rapid stool test; rapid ova and parasites; rapid c-diff; imaging of descending colon, appendix, gall bladder
American Academy of Family Physicians: www.aafp.org
Commonwealth Fund: www.commonwealthfund.org
Stoeckle Center for Primary Care Innovation at Massachusetts General Hospital: www.massgeneral.org/stoecklecenter
National Committee for Quality Assurance: www.ncqa.org
Patient Centered Primary Care Collaborative: www.pcpcc.org
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Program Director, POCTRC