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Ensuring Employees Are OK, Race and Patient Experience, FDA on Trial Diversity-The HSB Blog 11/17/20

5 Ways to Make Sure Your Employees are Okay

Event: On November 12th, Benefits Pro released an article advising five ways employers can make sure their employees can successfully navigate the stressor caused by the COVID pandemic. With millions of people affected by the Virus, Benefits Pro reminds employers not to overlook the toll it can take on the mental health of their employees.

Description: With all of the virus' stressors, U.S. workers are experiencing higher than average levels of mental health issues during the pandemic. While HR and employee relations teams would normally want to step in and help, working remotely makes it difficult to identify exactly who needs assistance. As such, advisers suggest five strategies on how to read between the lines and offer support to employees who may be struggling.1) Set up frequent touchpoints-connect frequently with employees both in team meetings and one-on-one which will allow employers a chance to assess how people are doing. 2) Use analytics to read between the lines-look for anomalies like significant reductions or massive increases in productivity. Either could signal employees are struggling. 3) Understand that women may face more hurdles than men so they may necessitate special focus. Research from CARE indicates COVID-19 is having a disproportionate impact on women, with Mothers, senior-level women and black women particularly at risk. 4) Make sure employees are aware of resources offered. Be proactive and remind employees of your benefits and ensure that furloughed employees are aware of any extensions of mental health benefits (if offered). 5) Share personal experiences to destigmatize mental health issues. For example, invite a C-level executive to share their experiences with employees so people who are struggling know they’re not alone.

Implications: Remaining productive and focused at work is challenging for many employees given pandemic induced stress of being isolated while working from home, balancing work and home-schooling, taking care of vulnerable loved ones, and more. As a result Employers need to be taking additional steps to proactively uncover mental health issues that may be brewing below the surface before problems become more serious. Given experts like Dr. Fauci don’t expect life to return to “some degree of normality” until late 2021 [even with a vaccine] employers will likely need to evaluate and strengthen the breadth and depth of their mental health offerings and the visibility of those offerings, at least for the foreseeable future.

Patient Experience Better When Patients Visit Docs of Same Race

Event: On November 11th, PatientEngagementHIT released a study conducted by the Perelman School of Medicine at the University of Pennsylvania, addressing the correlation between patient experience scores and the race of both patient and doctor. In addition, the study looked at the need for health systems to address racial implicit bias in medical settings. The study concluded that patient experience scores tend to be at their highest when a patient sees a physician of the same race and that health systems must do a better job at addressing implicit racial bias in medical settings.

Description: The researchers looked at approximately 120,000 patient experience scores for an urban academic medical center, focusing on the “likelihood to recommend” domain. The study found that patients who saw physicians of their own race or ethnicity were more likely to rate their physicians higher on patient experience surveys than those who saw physicians of a different race or ethnicity. Although the differences in rating seems small, with black patient’s rating white physicians 0.03 points lower on “likelihood to recommend” than their rating for black physicians, that 0.03 points difference could lower a physicians mean score on Press Gainey ratings from the 100th percentile to the 70th percentile.

Implications: The results of the study reiterate the association between race/ethnicity and patient-physician interaction/ outcomes and the implicit racial bias black patients have experienced in healthcare. This ultimately impacts healthcare delivery, health disparities, and morbidity and mortality rates amongst African Americans. The results serve as a warning for healthcare organizations, especially those that may rely heavily on patient experience scores for compensating physicians, and that addressing the needs of their patients from a culturally diverse perspective is crucial. The study reinforces the belief that cultural competency and efforts to address implicit bias in healthcare is essential as is the need to understand/pay attention to non-verbal social cues.

FDA Releases Final Guidance on Clinical Trial Diversity

Event: On November 9th, the FDA finalized guidance for promoting diversity in clinical drug studies and released its report “Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry ''. The guidance considers both demographic considerations (ex: sex, race, ethnicity, age, location of residence) and non-demographic characteristics (ex: comorbid conditions, disabilities, those at extremes of weight range, etc) of populations.

Description: The FDA’s 21 page guidance includes recommendations on how clinical trial teams can widen eligibility and enrollment groups for those historically underrepresented in trials such as the Black and Latinx community, pregnant women and those with certain physical conditions. Recommendations include, broadening eligibility criteria to increase diversity by among other things, requiring fewer exclusions related to concomitant medications (prescriptions or OTC drugs/supplements that may cause side effects) or comorbidities as more data on drug metabolism and drug-drug side-effects becomes known. In addition, the guidance suggest sponsors should make more effort to enroll participants who reflect the characteristics of clinically relevant populations with regard to age, sex, race and ethnicity stating that sponsors should include an “inclusion plan” no later than the “end of the Phase 2 meeting”. The guidance also states that sponsors should look at trial design and methodological approaches such as adaptive trial design and enrichment to broaden participation.

Implications: The guidance clearly raises the bar for sponsors to be more proactive in trial design and recruitment so that they can “endeavor to include diverse populations to understand …risks and benefits [of medical products] across all groups. In the guidance the FDA made clear that sponsors will be responsible for taking additional steps including offering and making patients aware of financial reimbursements for expenses associated with costs incurred to participate in trials. In addition, study designers are going to have to ensure that they incorporate ways to reduce the frequency of clinic visits for elderly and disabled by using digital tools like electronic informed consent, telehealth and remote blood pressure monitors to replace or supplement in-person visits as well as mobile medical professionals (ex: nurses and phlebotomists) when that isn’t possible. Finally, the guidance notes that to broaden participation sponsors will have to engage underserved populations earlier in the drug development process and work more closely with communities through outreach and public education efforts to assess trial participant needs and drive higher support.

Designing Better Tech for Seniors Means Simplifying Tech for Everyone

Event: A recent article in Mobihealthnews noted that many caregivers have turned towards technology and digital health solutions to keep older adults healthy and independent. A recent report from Rock Health highlighted that 77% of people over the age of 55 say they want to age in place, and only 50% believe they will because of barriers such as home maintenance, lack of transportation and mobility, inadequate preparation, and age-related accessibility.

Description: Since 2010, the 65-and-older population has grown by over a third and by 2030, one in every five Americans will be of retirement age. As the demographics of the U.S. age, many caregivers have turned towards technology and digital health solutions as ways to keep older adults healthy and independent. In addition, according to a recent study, more than 60% of Medicare-eligible seniors say they’ve embraced technology more during the pandemic. Consequently. tech developers need to create products targeted at older adults that are designed to help them age and stay independent without stigmatizing them. Digital technology for seniors should be created with the P’s in mind – purpose, people, and possibilities. Technology built with a purpose makes seniors feel useful in society and their communities. It is associated with fewer heart attacks, better sleep, lower stress hormones, better immune system, and lower healthcare costs. Using digital health technology to connect with people can reduce isolation, affecting about 25% of adults over the age of 65. Isolation and loneliness lead to higher blood pressure risks, heart disease, obesity, a weakened immune system, anxiety, depression, and even death.

Implications: As time progresses, technology is evolving and will outpace the ability to keep up with it. Barriers that keep seniors from using technology include a lack of instructional guidance on using it, a gap in knowledge, poor eyesight and hearing, and cost. Designing technology for everyone means creating customization features for smaller populations critical in making better solutions for seniors while remaining usable for everyone. Digital health technology should be customized to ease and assist seniors in their daily living activities while being in full control of their health. With a disproportionate share of COVID deaths occurring in senior care facilities, more older Americans are likely to want to live independently longer and the design of technology will need to keep pace. If it does, with the increased application of technology, seniors can decrease loneliness and experience better mental and physical health for longer periods without needing to be cared for in an institutional setting thus saving costs and improving quality of care and quality of life.

From Today to Telemedicine: 3 Gaps and Risks

Event: A recent article from Healthcare Dive pointed out the growing trends in telemedicine since the pandemic, and its usefulness for patients who live in remote areas and especially for those who are elderly and/or otherwise at high risk for contracting COVID. However, while the healthcare industry makes the case for greater use of telemedicine, 3 key risks and gaps were identified that must be addressed for it to be a vital and enduring component of virtual care.

Description: As COVID hit, face-to-face office visits dropped, and telemedicine took a sharp rise (tenfold increase). If telemedicine is here to stay for the long run, there are 3 identified risks/gaps to be addressed: 1) Health Care Providers (HCPs) need to be comfortable with telehealth technology-among 1700 physicians surveyed in June only half were comfortable with the current technology, 2) HCPs need tools for going beyond “superficial” observations. Using current technology providers may be able to spot the usual but miss the unusual leading to potential misdiagnosis or medical errors, 3) Policies need to support telemedicine-COVID prompted temporary relief with reimbursement in telemedicine visits, however, until there are comprehensive reimbursement policies, it is likely to still have gaps in telemedicine availability.

Implications: The pandemic has had a tremendous positive impact on telemedicine; it has allowed patients to accept this new platform of care. This method of delivery of care is highly dependent on physicians. Thus physicians must wholeheartedly embrace the new technology and must be responsive. As digital health tools become more widely deployed, additional tools and product development are going to be required to ensure proper remote diagnosis (ex: IoT sensors, bluetooth enabled diagnostic devices, etc.). While a number of regulatory hurdles were quickly set aside during the pandemic, regulators, payers and providers will have to reassess the ecosystem to bring policies and regulations up to date with the years of progress gained in only the last 8-9 months.

Clashing Studies Highlight a Digital Health Void

Event: On November 11th, STAT HealthTech released an article reviewing sharply contradictory studies on a new product from Pear Therapeutics. The new product is reSET-O, a prescription digital therapeutic that uses software to deliver cognitive behavioral therapy to patients with opioid use disorder.

Description: While a study from Expert Review of Pharmacoeconomics & Outcomes Research showed that Pear Therapeutics reduced hospital stays, emergency department visits, and other care in a group of 351 patients, another study from the Institute for Clinical Economic Review presented that reSET-O would actually increase costs by $1,400 over a five-year period compared to the current standard of care. Surprisingly, neither study is necessarily wrong. Each study evaluated the product based on different sets of information over varying time periods.As noted by the Digital Therapeutics Alliance, digital therapeutics rely on high quality software to deliver evidence-based interventions to patients to prevent, manage, or treat disease…[and] can be used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.” As such evaluating their effectiveness involves an entirely different regulatory approach than current therapies.

Implications: The different results from the two studies show that further research and clear evidentiary standards are needed to evaluate digital therapies and services. If conclusions remain conflicted, these products will remain mired in confusion. In addition, without clear standards the category could remain susceptible to fraudulent products or claims. As such, it is incumbent on the industry and trade groups such as the Digital Therapeutics Alliance to develop widely accepted, transparent and reproducible standards of effectiveness.

Clashing Studies Highlight a Digital Health Void (STAT HealthTech-Subscription Required)


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