NEWS & EVENTS
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Diagnostics and Disease Management Tools for Use in Underserved Populations: An NHLBI Research & Implementation Workshop

April 14 - 15, 2021
Virtual event

Description

On April 14-15, 2021, the NHLBI convened a virtual workshop aimed at using technology to improve heart, lung, blood, and sleep health in historically underserved, low-resource, and remote communities. The goal was to identify more accessible and feasible technological solutions for disease diagnosis and management in these groups, highlight the ones that could have the greatest impact, and determine the ones best suited for further research. During the two-day event, approximately 1,800 participants came together to discuss sustainable and affordable technology solutions, effective community-based strategies, aand innovative models for disease management and diagnosis in underserved populations. Participants included academic researchers, implementation scientists, technology and medical device experts, and community and federal health leaders.

On the first day, experts highlighted recent research on diagnostic tools for heart, lung, blood, and sleep disorders, implementation systems, and insights on applying these systems to improve health outcomes in underserved populations. On the second day, federal and community leaders shared successful stakeholder partnerships that could serve as models. They also discussed areas that needed improvement. In addition, speakers and participants discussed implementation challenges and collectively brainstormed ways to apply these advancements and innovations to heart, lung, blood, and sleep conditions for underserved populations. Highlights are included below:

Technology, Diagnostic Tools and Metrics

Internet Access

Lack of broadband Internet access emerged as a dominant challenge to delivering the health-related technologies that rely on these services. Inequities in access to care and access to broadband Internet are correlated. Sustained efforts to improve Internet access to underserved populations are needed to impact health equity. Using multiple ways to connect with communities, such as telephone calls or in-person visits, could help for those with limited access.

Technology Integration

Integration of multiple technologies and platforms (point-of-care devices, wearable devices, app-based or patient-operated platforms, and digital health) is needed to provide continuous, real-time feedback on health measures. Innovative technology solutions need to take a targeted patient-centered approach that is individualized and adaptable to patients’ needs, bridges communication gaps, and integrates shared determinants of health.

Electronic Health Records

Information taken outside of traditional patient visits can be incorporated into electronic health records and potentially redefine where access-to-care and point-of-care takes place.

Metrics

Common metrics are needed to define health outcomes or study endpoints, to evaluate program or intervention impacts, and to ensure comparability over time as technology and methods evolve. Metrics should be important and relevant to the underserved population. All stakeholders should be included when selecting metrics, especially for value-based metrics (i.e., quality of care), which can require substantial resources to collect and/or harmonize data. The Centers for Medicare and Medicaid Services (CMS) are a key stakeholder which ensures clinical quality data are measured, patient-generated data are included, and clinicians are incentivized to use the data as quality control.

Accessible Diagnostics

The COVID-19 pandemic inspired innovation and reshaped rapid diagnostics platforms. It shows that affordable and accessible diagnostics (e.g., for COVID-19 testing) can be developed and disseminated rapidly. This experience offers hope that similar platforms could be used to identify patients in need of emerging curative therapies. Patients need access to basic diagnostics until future capabilities become available. At that point, diagnostic technologies could monitor the effectiveness and efficiency of curative therapies.

App-based, Patient-operated Platforms

  • Apps should be designed intuitively for specific persons and sensitive to their needs (i.e., culturally sensitive, language dependent). Their experience will impact whether or not they use the app.
  • For mobile apps, the accuracy can vary depending upon the user (patient, health care provider, family member). Research shows that the older the patient, the less accurate the result.
  • Wearable monitors and sensor devices have become more common and can be used as a low-cost tool for monitoring health status, interventions, and outcomes.
  • Text-based behavioral interventions have shown promise in reaching diverse communities when messaging is tailored appropriately.
  • Digital health platforms can play a central role in integrating test results. For example, lateral flow assays (LFAs) can read and provide digital confirmation of results. They also can track symptoms, provide instructions for use, and integrate data from wearables.
  • Smart phones have become more common and can be essential tools for data collection, transmission, and integration of health metrics and information; for information delivery and consumption; and for remote access and interaction with the health care system and providers.

Point-of-Care (POC) Technologies

POC technologies have the potential to reach communities that are underserved by health care systems, and they can screen, diagnose, and/or monitor treatment. The following are examples:

  • A POC blood test that can detect hemoglobin levels: This technology was developed for people with anemia and sickle cell disease.
  • Portable systems and monitors: Patients can use these devices at home. Examples include high flow oxygen delivery systems, portable sleep monitoring for diagnosis of obstructive sleep apnea, and home polysomnography that may provide more ecologically valid information on sleep quality and sleep disorders.
  • Telehealth visits: These visits are a type of POC assessment, enabling providers to observe conditions or situations associated with shared determinants of health or other contributors to disease, as well as direct medication reconciliation.
  • Electronic inhaler monitoring systems: These devices can provide real-time objective assessments of secondary medication adherence, including overuse, deviations from scheduled administration, forgotten doses, etc.

Telemedicine and Telehealth Services

Telemedicine use dramatically increased during the COVID-19 pandemic. African Americans, Hispanics, and those over age 65 were much less likely to use a video visit versus a telephone call. Telemedicine challenges include access to broadband Internet, technology literacy, physician training/acceptance of telemedicine, and billing issues.

Before the COVID-19 pandemic, reimbursement for telehealth was limited. Health centers funded by the Health Resources and Services Administration (HRSA) expanded their telehealth services during the COVID-19 pandemic, and CMS enhanced reimbursement so that telehealth–enabled health centers could expand telehealth services and continue providing care during the pandemic. The Federal Communications Commission (FCC), other federal agencies, and broadband providers are now working together to provide the service to people by improving access to broadband. Billions in spending toward improving infrastructure may include improved broadband Internet and affect telehealth.

Return on Investment

Developing product solutions for underserved populations can have a low return on investment for companies which makes public sector investment all the more important to facilitate development and implementation.

Regulatory Path

In many situations, regulatory path and reimbursement are not clear. Patent protection can be challenging in certain cases.

Communities, Residents and Health Disparities

Sustained Community Partnerships & Engagement

Partnerships with the community drive and accelerate innovation to implementation and are key to impacting health in underserved populations. Developing sustainable partnerships requires in-person engagement and takes investments of time, effort, and resources to build trust, understand needs, and develop meaningful relationships. Common themes included:

  • Engagement provides an entry point for diverse and underserved individuals as equal partners in the research. Build research capacity in historically excluded communities.
  • Meaningful communication, sustained connection, and coaching for researchers and community partners are best practices for building and maintaining partnerships with diverse and underserved communities. Use a variety of communication strategies to accommodate different partner needs and preferences.
  • Trust is essential for effective partnerships. Lack of trust affects recruitment, enrollment, and inclusion of underserved populations in research, and the translation of research to benefit underserved communities. Acknowledge and measure mistrust of medicine and research among individuals and communities you want to serve. Lack of trust plays into privacy and security concerns, willingness to share data, and suspicion about how the data will be used.
    • Use data in a way that is tailored and benefits each specific underserved community so that trust around data collection can shift. Partner with community leaders and advocates to help advance issues around trust and distrust.
    • Meet underserved populations in their communities. Acknowledge and recognize respected community leaders as part of the research continuum.
    • Gatekeepers and trusted brokers in communities care about the same issues with respect to health equity. The best approach is understanding them and leveraging the opportunities they view as ways in which inroads can be made in their communities.
    • Each community is different and unique in their experiences, perceptions, and needs.
    • Invest in workforce development to sustain community relationships and to conduct research that accounts for community needs and values:
      • Junior investigators interested in health equity research
      • Individuals from the community who can play roles as champions
      • Community health workers
    • The research culture does not always support incentives, community engagement, and sharing of power. It also does not allow time for effective partnerships to naturally take place within a typical five-year grant cycle. The NIH and academic institutions should recognize these workforce needs.
    • Tribal nations are sovereign nations. Working with these nations requires approvals through tribal leaders and elders, who should be regarded as partners in the research.
    • The research community can accelerate innovation by focusing on topics relevant to underserved communities, by increasing diversity among individuals engaged in health-related research, and by recruiting diverse study participants.
    • Community health workers can serve key roles. They understand their community and can assist with addressing social determinants of health and health education. They also can help improve access to care through patient navigator role (although it is highly service and labor intensive).

Social Determinants of Health

Disparities in health outcomes have been associated with certain social determinants of health. Measures need to incorporate health services payment formulas to prevent greater disparities and bias in health outcomes. Workshop participants described numerous challenges and opportunities:

Challenges

  • Changes in unhealthy living conditions may not be feasible or easily addressed.
  • Lack of nearby specialty care and privacy concerns related to collection of health information.
  • Geographical and social isolation contribute to depression and other mental health issues, which exacerbate chronic health conditions.

Opportunities

  • Technologies can focus on helping patients locate resources in their community to access basic needs (healthy foods, shelter, employment).
  • Community health workers can help with obtaining the services and resources needed to gain trust regarding privacy concerns and to train on use of technologies.
  • Payers are allowing purchase/reimbursement of health technology devices. Precision health could potentially promote integration of social needs in context with the clinical diagnostics and management.

Specific Communities and Groups

Rural Native American Communities

Researchers should diversify their study populations, use local investigators’ knowledge of the community, and de-emphasize concern for prior publications and need for preliminary data for evaluating proposals. Partner more with tribal and undergraduate institutions in addition to research intensive institutions. Seek administrative efficiencies and more budgeting flexibility to carry funds over from year to year.

For remote communities far from health systems, such as some tribal nations, wearable devices could be utilized to monitor health in real time. It is possible to record data from wearable devices (such as personal health and wellness measurements) in a cloud-based secure system, and then display the results in a patient-friendly way.

Essential Workers

Essential workers can experience gaps in education, wealth, and income. They also face occupational disparities which can contribute to health disparities. For example, African Americans are more likely to work in jobs considered essential during the COVID-19 pandemic, and essential workers are not able to work from home. Health care providers could use mobile technology to deliver health messages to them and send reminders to make appointments. Workers could also use an app to contact their provider or access other services and related information. Developing a mobile app to assess these workers for burnout, stress, and cumulative stress/life challenges could help mental health efforts.

Nursing Home Residents

Nursing home residents often have unique healthcare issues and needs that may be served by emerging technologies. For example, they are at risk for anemia, and it’s challenging to get blood draws from them because it can be difficult to find a vein. New light-based technologies can help locate veins and superimpose the vein grid on the patient’s arm.

Rural Residents

Some rural residents don’t have access to smartphones, but researchers can provide study participants with smartphones to use during a study.

Cultural and social differences, stigmas, and norms are important factors to consider when developing health research programs to address needs and challenges of rural communities; rural communities in the South may have unique identities compared to those in the Midwest. However, culture as a characteristic that’s attributable only to geographic location does not help to advance rural health research. Rural communities are not homogeneous, and each rural community has many unique aspects.

Research Study Implications

No-Touch Clinical Trials

Due to COVID-19, many researchers developed a low-touch strategy that brings the trial to the patients, making a no-touch treatment trial achievable. E-consent is critical. This strategy can be adapted and used for rural and underserved populations. It can be tailored to patients for either devices or treatments, and supportive materials are available to enable remote, centralized follow-up.

Community Mistrust

Issues surrounding community mistrust can affect research studies, but many in the community are excited to participate in research studies. Participants appreciate the attention and focus on their health. Sometimes researchers assume that participants won’t participate because of mistrust; however, they want us to instead acknowledge their mistrust and be responsive to their concerns.

Study Participation

Some study participants are unfamiliar with technology, struggle to adhere to daily device use, or complete surveys. Researchers can ensure that staff are trained to connect with participants, enlist the help of tech savvy relatives if needed, and use screen sharing when broadband access allows. They also can follow up with emails or phone calls to provide support during the study.

Sleep

One challenge in studying sleep is having the community accept that measuring brainwaves during sleep is a relatively easy, non-invasive, and information-rich diagnostic. The equipment and results can be mailed to the patient or participant rather than have them go to a specialist. People can also now use remote or portable technology in the form of a small box that can monitor breathing position, oxygen saturation, heart rate, and other measures. Researchers are able to monitor large groups remotely enabling those located in remote areas to be studied in places with no sleep laboratories.

Barriers to Disease Management

Barriers to managing disease in underserved populations can include technological literacy, cellular/broadband access, and data integration and interoperability. Opportunities to improve care include enhanced home point-of-care assessments, remote patient monitoring, and novel pulmonary rehabilitation approaches.