Solicitations

2024 Award Competition: Center for Advancing Point of Care Technologies in Heart, Lung, Blood and Sleep Disorders – Funding Opportunity

Award Information

Review Criteria

FAQs

Timeline:

Solicitation Release: February 20, 2024  
Expression of Interest Due: March 31, 2024 11:59 PM EDT  
Invitations for Full Proposals:  April 29, 2024  
Full Proposals Due: June 2, 2024, 11:59 PM EDT  
Notification of Successful Applicants:  August 5, 2024  

Questions? Contact: MaryAnn Picard 
Email: maryann_picard@uml.edu   

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Funding Opportunity

The Center for Advancing Point of Care Technologies (CAPCaT) in Heart, Lung, Blood, and Sleep Disorders (U54HL143541) announces the 2024 solicitation of grant applications focused on developing, adapting, or validating point of care technologies that can be rapidly applied to heart, lung, blood, or sleep disorders, with additional interest in projects that incorporate complementary and integrative health approaches. We plan, based on the receipt of meritorious applications, to fund up to four awards of up to $100,000 over 12 months, with one or more award(s) focused on complementary and integrative health. 

Areas of Focus 

This national solicitation for CAPCaT’s pilot funding aims to attract research applications focused broadly on accelerating the development and clinical testing of point of care technologies for heart, lung, blood, and sleep (HLBS) disorders.  

We conducted clinical needs assessments in 2019, 2020, and 2021 that identified chronic cardiovascular diseases, coagulopathies and other blood disorders, sleep disorders and lung diseases as the top conditions for which POC technologies could help diagnose, monitor, better manage, or prevent condition(s) (including complications of COVID-19) across the Heart, Lung, Blood, and Sleep spectrum. Additionally, accuracy, ease with which the technology could be incorporated into existing clinical workflows, availability, and cost were identified as the most important POC characteristics to healthcare providers. Applications that seek to address the conditions listed above, that have the desirable characteristics listed above, as well as those that address health disparities/social determinants of health will be given special consideration. We are particularly interested in the development of disease diagnostics and monitoring devices, wearable technologies, mobile applications, and other tools to improve heart, lung, blood, and sleep (HLBS) health in historically underserved, low-resource, and remote communities. We are also interested in the development of tools and technologies that will address barriers to uptake of the implementation and dissemination of evidence-based interventions for HLBS conditions and disorders in minority and low-income communities. Taken together, these areas of focus will be the basis for this funding round.  

 Areas of focus related to heart, lung, blood, and sleep disorders:  

• POC technologies that aid in the home-based management of cardiometabolic disease by identifying acute decompensations (i.e., detection of an acute flare of chronic obstructive lung disease or decompensation after COVID-19 infection, thereby avoiding hospital admission) in specific populations (e.g., according to race, ethnicity, sex/gender, socioeconomic status).  
• POC technologies that help better define patients at risk of bleeding or thrombosis, including key groups such as those treated with anticoagulants for pulmonary hypertension, venous thromboembolism, pulmonary embolism, or atrial fibrillation.  
• POC technologies that help differentiate patients with atherosclerotic heart disease who will progress to myocardial infarction or sudden death from those with stable disease.  
• Technologies that can monitor or enhance physiological responses to therapies (e.g., continuous positive airway pressure devices) at the point of care for the treatment of sleep disorders.  
• POC devices that define physiologic, phenotypic, or molecular characteristics to predict HLBS outcomes and, when applied in clinical studies, predict differential responses to therapy in individuals and in different populations with HLBS disorders (e.g., sickle cell disease, heart failure).  
• Mobile health (mHealth) and telehealth/telemedicine technologies and apps for improving communication among health care providers and between patients, families, and physicians and healthcare providers, medication adherence, diagnosis, monitoring, evaluation, medical management, screening, tracking, and treatment in underserved community settings and rural and remote locations.  
• Leveraging robotic and autonomous systems for improving health, and preventing, reducing, and eliminating health disparities.  
• “Smart” POC devices that both monitor physiology and use novel algorithms to assist, adjust, or intervene automatically to treat acute complications of cardiovascular disease (e.g., a heart failure monitor that can be used to adjust diuretic dosing to reduce acute heart failure worsening).  
• POC technology that enables real-time, individual-level remote monitoring that would be used to detect and predict worsening respiratory status and reduce risk for intubation or hospitalization (i.e., in the context of pneumonia or recovery from COVID-19).  
• POC technologies well-suited for use by healthcare providers in the ambulatory clinic or home setting that accurately measure critical determinants of health, including treatment adherence, integrate them into the electronic health record, and enhance quality of care.  

Areas of focus related to complementary and integrative health:  

These approaches include natural products, such as herbs, prebiotic, probiotics, and selective medical diets, and mind and body practices including acupuncture, meditation, manual therapies (e.g., spinal manipulation/mobilization), hypnosis, meditative movements (e.g. tai chi, yoga, etc.), and music/art therapies.  

• POC devices or applications that can monitor the dose, intensity, duration and/or frequency of complementary and integrative health approaches employed by the patients at the point of care.  
• Solutions that integrate multiple signals into a signal output to measure the effectiveness of complementary and integrative health approaches, such as yoga and meditation, especially across HLBS metric (e.g., blood pressure, sleep).   
• POC devices or applications that use Artificial Intelligence/Machine Learning (AI/ML) to understand the effects of multicomponent interventions on multiple physiological and biological systems to monitor or quantify physical and/or emotional well-being, breathing, or sleep.  
• POC technologies to improve biological and physiological outcome measures for use in clinical studies of complementary or integrative health approaches.  
• POC technologies that can objectively measure pain or functional limitations due to pain, which would be treated by complementary and integrative health approaches, at home or in primary care facilities.  
• Virtual reality (VR) systems that use therapy and other behavioral methods to help with pain reduction.  
• Development and validation of gaming and virtual reality technologies for the accurate assessment of adherence and/or fidelity to the use of mind and body practices and interventions.  

• POC technologies that can monitor symptoms, health related quality of life, or physiological responses to complementary and integrative health approaches at POC for the treatment of pain, mild to moderate depression, anxiety, or other symptomatic conditions, especially if they are applied across the heart, lung, blood, sleep disease spectrum.  
• POC technologies that can objectively assess or monitor stress, pain, sleep dysfunction, depression, or anxiety, which would be treated or managed by complementary and integrative health approaches, at home or in clinical environments.   

Point of Care Technologies Performance Criteria 

We advise applicants to consider the following performance criteria for their POC technologies: 

• Voice of the End User – Healthcare providers: Accuracy, availability, cost, and ease with which the technology could be incorporated into existing clinical workflows were identified as important POC characteristics by surveyed healthcare providers. 
• Voice of the End User – Patients: Accuracy, immediate result availability, and out-of-pocket cost were identified as important POC characteristics by patients who participated in our needs assessment surveys. Applicants must understand the use case of the technology in the context of where the product will be used. Applicants must consider how the technology will be used to help eliminate health disparities (for example, is the product available in multiple languages, will it function in areas with low internet connectivity, etc.). 
• Analytic Performance: As a rule, the performance of POC devices should be equivalent to central laboratory instruments regarding analytical accuracy, reportable range, and precision. Analytical time should be kept to a minimum (less than 5 minutes for common chemistry analytes and less than 15 minutes for immunoassays). Should a predicate device not exist, published preliminary data can be used to evaluate performance. 
• Ease of Use: Ease of use is essential to successful implementation of POC 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. 
• Workflow: The POC technology should not require clinicians or staff to significantly alter the way they care for and treat patients in their practice setting and should ideally integrate into existing electronic systems. 
• Result Availability: Results must be available in the home, at the hospital bedside or during an office visit (typically 10- to 20-minute result availability), so that decisions can be made in a timely fashion based on the test results. 
• 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. 
• Sample Types: Samples that do not require a trained phlebotomist should be used, such as capillary finger-stick whole blood or saliva. 
• Storage of Consumables: All consumables, including reagents, calibrators, and quality control materials, should be stored at room temperature. The minimal shelf life should be 6 months to 1 year. 
• Device Footprint: POC devices should be designed to have as small a footprint as possible. Small benchtops or handheld devices are optimal. 
• Information Connectivity: All instrumented POC devices should be capable of being interfaced to the electronic medical record system. The ability to transmit data using a bidirectional wireless interface is most optimal. 
• Security of intellectual property: Clearly articulated security of intellectual property will be considered most strongly (may be issued or pending patents, or, for software, trademarks, or copyrights). 
• Cost: Solutions that significantly reduce the cost of testing relative to the existing standard of care are encouraged.