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Digital Home Hospital Solutions Can Play a Valuable Role in Decentralized Clinical Trials

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Originally published in PharmaLeaders


Authored and contributed to PharmaLeaders by: Gary Manning, Senior Vice President and General Manager, Healthcare, physIQ, and Mike Petrarca, Senior Vice President and General Manager, Life Sciences, physIQ

For more than a few years, buzz has been steadily building around digital home hospital care models. However, the pandemic has accelerated enthusiasm for taking the development and implementation of this innovative approach to the next level. Furthermore, the proliferation of decentralized clinical trials is paving a new path for driving the expansion and adoption of wearable biosensors and continuous, streaming physiologic data as an essential part of clinical development.

Before we delve into the why, let’s start by defining the digital home hospital care model. The American Hospital Association describes it as a care delivery model that enables some patients to receive acute-level care in their homes rather than in a hospital.1 In 1995, Johns Hopkins created the first hospital-at-home model in the United States and pioneered it in multiple sites across the country. A decade later, the first national study of the model reported numerous benefits, including better clinical outcomes, shorter average length of stay, higher patient and family satisfaction, fewer lab and diagnostic tests, fewer complications and costs savings of up to 30 percent compared to traditional inpatient care.2

Multiple Factors Drive Expansion

Digital home hospital care models have continued to gain traction for several reasons. These include major advances in telehealth and remote monitoring technologies, rising consumer expectations for improved care experiences and pressure from payers for less-expensive care alternatives. Then, of course, there’s the impact of the pandemic.

Patients afraid of being exposed to COVID-19 and its variants prefer being treated at home, and they also appreciate that caregivers and family members can remain with them, unlike in the hospital. For hospitals, pandemic-related benefits of a digital home hospital care model include the ability to keep hospital beds available for the most acutely ill patients and to maximize limited resources, from ICU space to clinicians to PPE.

The pandemic also fueled dramatically increased flexibility in CMS reimbursement policy. CMS’ willingness to begin covering care services provided outside of a hospital setting, including patients’ homes, has removed a significant barrier to the more widespread adoption of digital home hospital/hospital-at-home models. As more hospitals and health systems jump on the digital home hospital bandwagon, the model continues to evolve.  New research shows that up to $265 billion worth of care services for certain Medicare beneficiaries could shift from medical facilities to homes by 2025.3

Digital Technology: The Critical Bridge

Not surprisingly, digital technology is proving to be a critical bridge and enabler to providing the high quality, cost-effective care that both providers and patients want.

Digital home hospital care models typically require eligible patients to be identified in the emergency department or an ambulatory care site. After being admitted/accepted into the program, they receive multiple daily in-person visits by nurses and physicians. Any necessary care infrastructure can be set up right in the home, including arranging for infusion services or medication delivery devices.

Increasingly, clinicians can use technology to replace many of the in-person visits with virtual ones. They can also take advantage of continuous remote patient monitoring (cRPM) to closely track patients’ health and alert them to early signs of potential deterioration. Integrating data with artificial intelligence (AI) and analytics has already shown tremendous promise for delivering personalized patient insights that can transform care at home.

cRPM Finds a Home in Decentralized Clinical Trials

Some of the best proving grounds have been decentralized clinical trials that deploy cRPM technology. When 80 percent of clinical trials shut down during the height of the pandemic to protect participant safety, the benefits of using digital options came clearly into focus. In fact, the wisdom and convenience of bringing the trial to patients rather than vice versa makes so much sense that up to 65 percent of life sciences companies plan to run clinical trials remotely, post-pandemic.4

Typically, clinical trials involve meeting the following goals: identifying the right participants, consenting and engaging them safely and demonstrating and/or evaluating the therapy’s safety and efficacy. In decentralized virtual models for clinical trials, subjects are enrolled via video conference or other digital options including eConsent, which invites discussion between caregivers and patients.  This may eliminate the need to go to the investigator site as previously required. Ideally, during the trial patients are monitored using a medical-grade, scalable platform that can support multiple therapeutic areas.

To optimize clinical trial performance and outcomes, the digital platform should be designed to continuously capture biosensor-generated patient data 24/7.  The platform’s system of analytics should have the ability to transform data into personalized insights using FDA-cleared machine learning (AI) algorithms. This same digital technology that enables trial sponsors, clinicians and patients to adhere to study protocols is also ideal for supporting adherence to care plans in hospital-at-home models.

Innovations Help Address Medication Adherence

With the growing ability to continuously capture and track near real-time physiological data – from respirations to heart rate to movement and more – researchers and clinicians can intervene sooner to preclude adverse events of a serious nature and prevent the need for admission, or readmission, to a hospital. Moving forward, these same capabilities will also support post-market surveillance for new drug therapies used by patients at home, enabling life sciences companies to monitor efficacy, safety (pharmacovigilance) and modify delivery or dosage based on real world data.

Continuing innovation and advances in digital technologies also offer exciting potential for future added-value capabilities in the clinical development and hospital-at-home environment, such as the ability to support improved medication adherence. Medication adherence is crucial to patient health and outcomes, yet it continues to be a significant problem. Poor medication adherence takes the lives of 125,000 Americans annually, and costs the health care system nearly $300 billion a year.5

In the current hospital-at-home model, multiple daily clinician visits support high levels of medication adherence by providing drug delivery oversight comparable to the in-hospital experience. Adding a layer of cRPM on top of this human oversight has the potential to further support medication adherence in several ways.

The continuous flow and analysis of patient data could alert clinicians to changes in their vital signs that might indicate side effects or non-compliance. Highly personalized digital surveys could be sent to patients daily to check on key health indicators. Validating the electronic patient-reported outcomes (ePROs) with the digital data could help clinicians intervene in a timely manner to address issues and prevent complications that affect patient health or safety. Also, advances in technology, such as an app that visually records patients taking their medication, may become another avenue to support medication adherence.

Finally, with the pervasive use of electronic medical records (EMR) across health systems, there’s an opportunity to ensure that home hospital care delivery is annotated into these EMRs through a direct connection with digital home hospital models.

Right Care, Right Medications, Right Time

As critical and transformative as digital technology is for enabling high quality care beyond hospital walls, its ability to improve the patient experience in both clinical research and healthcare may be its superpower. Digital home hospital models have already demonstrated the ability to increase patient and family satisfaction, while digital applications within clinical trials hold the promise of better compliance and more efficient trials. With the right technology, clinicians and researchers can deliver the right care and the right medications at the right time to more patients in the right place – which for many, is in the comfort and familiarity of their own home. When patients, health care systems and life sciences companies trust that hospital-level care can be safely, efficiently and cost-effectively provided at home.

 

Footnotes:

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2621275/

2 https://www.beckershospitalreview.com/patient-safety-outcomes/hospital-at-home-cheat-sheet-7-qs-on-the-care-model-answered.html

3 From Facility to Home: How Healthcare Could Shift by 2025 | McKinsey

TMF Futures 2021 Report, Arkvium (as reported by Fierce Biotech, 8/9/21)

5 Medication Adherence – Taking Your Meds as Directed | American Heart Association