May 2, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing
Despite logistics and test volume concerns for laboratories, hospital-in-the-home services promise to reduce cost and improve quality of care for patients who might be negatively impacted by the noise, stress, and germs of busy hospitals
In April, The Washington Post highlighted the plight of 71-year-old Phyllis Petruzzelli—a patient with a weakened immune system suffering from pneumonia. Instead of admitting her into a noisy ward and exposing her to other germs and infection vectors, doctors at Brigham and Women’s Faulkner Hospital in Boston chose a different approach. They treated her in her home with a remote monitoring patch and in-home visits. Three days later, she was well and referred to her primary care provider for follow-up.
This is an example of the hospital-in-the-home model of clinical care. It is not a new concept and is being developed in a number of countries. In the United States, managers at medical laboratories, hospitals, and integrated health systems will want to stay informed about the ongoing efforts to use the hospital-in-the-home method as a way to improve patient care while lowering the overall cost of a healthcare encounter. One reason is that patients receiving care in their homes will need to be serviced by clinical laboratories.
David Levine, MD, Clinician-Investigator at Brigham and Women’s Hospital, told The Washington Post that despite initial reservations from staff, their testing of hospital-at-home care has been positive. “[Staff] very quickly realize that this is really what patients want and it’s really good care,” he stated.
Hospital-in-the-Home Costs Less, Better Care
Levine is lead author of a study published in the Journal of General Internal Medicine that compared the costs, quality, safety, and patient experience of 20 adult individuals admitted to emergency departments for an infection, exacerbation of heart failure, chronic obstructive pulmonary disease (COPD), or asthma.
“Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p < 0.01) lower,” the study authors note, “with trends toward less use of home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups.”
Though authors acknowledged the need for a larger trial to create definitive results, they concluded that home-hospitalization resulted in reduced cost while allowing improved physical activity.
David M. Levine, MD (above right), Division of General Internal Medicine and Primary Care at Brigham and Women’s Hospital, describes the home hospital, a novel care model that brings hospital services to patients at home. Click on the image above to view the video. (Photo and caption copyright: Brigham and Woman’s Hospital.)
Hospitals caring for patients in their homes is not a new concept. In 2012, Dark Daily reported on a similar trial involving 323 patients across a year at Presbyterian Healthcare Services in Albuquerque, New Mexico. The study found patients of their hospital-based home care (HBHC) program achieved savings of 19% when compared to costs of similar hospital acute care patients.
And a 2011 study conducted by Deloitte Access Economics found that hospital-in-the-home (HITH) care costs an average of 22% less than hospital care for a range of common conditions and uncomplicated diagnosis. (See Dark Daily, “Australia’s ‘Hospital in the Home’ Care Model Demonstrates Major Cost Savings and Comparable Patient Outcomes,” December 5, 2011.)
Hospital-in-the-Home Care Impacts Pathology Groups and Medical Laboratories
One reason for the reduced costs should concern medical laboratories and other service providers—less diagnostic tests ordered. “During the care episode, home patients had fewer laboratory orders (median per admission: six vs. 19; p < 0.01) and less often received consultations (0% vs. 27%; p = 0.04),” noted the authors of the Brigham and Women’s Hospital study.
Another complication of HITH for clinical laboratories is the patient’s location. When tests are required, clinical laboratory personnel must collect samples in patients’ homes. This could prove a logistical challenge for both independent laboratories and hospital-based labs. Adding overhead for transportation and collection to an already shrinking volume of tests could negatively impact laboratory workflow and revenues alike.
Nevertheless, though HITH is still in its early stages, studies continue to show positive results. The biggest hurdle to adoption of HITH is convincing payers to cover it. Should providers find a way to convince payers to support the new approach, rapid growth of HITH programs is likely.
As more lab-on-a-chip, lab-on-a-fiber, and similar point-of-care diagnostic testing technologies mature and integrate with telehealth solutions and electronic health record (EHR) systems, they also could combine with HITH trends to further impact volumes and margins for clinical laboratories of all sizes.
Healthcare delivery is evolving, and clinical laboratories and pathology groups must remain flexible and support these advances. In adapting to changes and providing flexible services—such as remote collection in HITH care episodes—laboratories can reinforce their value in today’s modern healthcare market and work to compensate for changes in how diagnostic tests and lab results are both utilized and delivered.
—Jon Stone
Related Information:
Hospitals Are Germy, Noisy Places. Some Acutely Ill Patients Are Getting Treated at Home Instead
Hospital-Level Care at Home for Acutely Ill Adults: A Pilot Randomized Controlled Trial
Wagga Base Hospital Program Gives Patients the Option for Treatment at Home
Admission Rates in a General Practitioner-Based versus a Hospital Specialist Based, Hospital-at-Home Model: ACCESS, an Open-Labelled Randomized Clinical Trial of Effectiveness
Impact of Home Health Care on Health Care Resource Utilization Following Hospital Discharge: A Cohort Study
HAI Data and Statistics
From Micro-Hospitals to Mobile ERs: New Models of Healthcare Create Challenges and Opportunities for Pathologists and Medical Laboratories
Australia’s ‘Hospital in the Home’ Care Model Demonstrates Major Cost Savings and Comparable Patient Outcomes
Two US Studies Show Home-Based Hospital Care Lowers Costs While Improving Outcomes and Patient Satisfaction
Feb 21, 2018 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
It has been regularly demonstrated in recent decades that human breath contains elements that could be incorporated into clinical laboratory tests, so the decision to use this “breath biopsy” test in a therapeutic drug trial will be closely watched
When a major pharma company pays attention to a breath test, implications for clinical laboratories are often forthcoming. Such may be the case with GlaxoSmithKline (GSK). The global healthcare company has selected Owlstone Medical’s Breath Biopsy technology for use in its Phase II clinical trial of danirixin (DNX), a respiratory drug under development by GSK for treatment of chronic obstructive pulmonary disease (COPD), an Owlstone Medical news release announced.
Anatomic pathologists and medical laboratory leaders will be intrigued by GSK’s integration of breath-based specimens in a clinical trial of a respiratory drug. The partners in the trial aim to analyze breath samples to better understand the drug’s treatment effects and to discover personalized medicine (AKA, precision medicine) opportunities.
GSK (NYSE:GSK), headquartered in the UK but with a large presence in the US, researches and develops pharmaceutical medicines, vaccines, and other consumer health products.
Owlstone Medical, a diagnostic company, is developing a breathalyzer for disease and says it is on a mission to save 100,000 lives and $1.5 billion in healthcare costs. Dark Daily previously reported on Owlstone Medical’s Breath Biopsy platform. The Cambridge, England-based company has raised significant funding ($23.5 million) and already garnered credible cancer trial collaborators including the UK’s National Health Service (NHS).
Now, Owlstone Medical has brought its breath analysis technology to bear on chronic disease outside of cancer diagnostics development. A pharmaporum article called Owlstone’s Medical’s work with GSK an “additional boost of confidence” in the company’s technology, as well as a means for revenue.
Billy Boyle, co-founder and Chief Executive Officer, Owlstone Medical (above), shown with the company’s ReCIVA Breath Sampler device. This will be used by GSK in its Phase II respiratory disease clinical trial of danirixin to “capture VOC biomarkers in breath samples.” (Photo copyright: Business Weekly UK.)
GSK Studying Future Treatments for Respiratory Diseases
COPD affects about 700 million people worldwide, an increase of about 65% since 1990, GSK pointed out. In September 2017, GSK presented respiratory disease data and its pipeline medications at the European Respiratory Society in Milan, Italy. Included was information on danirixin (an oral CXCR2 antagonist), which is part of the company’s focus on COPD disease modification, according to a GSK news release.
“Each of our studies sets the bar for our future research and innovation,” noted Neil Barnes, MA Cantab, FRCP, FCCP(Hon), Vice President, Global Franchise Medical Head, GSK Respiratory, in the GSK press release.
Clinical Trial Aimed at Identifying the ‘Right’ Patients
With Owlstone Medical’s breathalyzer, GSK plans to explore how volatile organic compounds (VOCs) can help identify patients who will benefit most from the company’s medications, as well as evaluate Danirixin’s effects. A critical element of personalized medicine.
“It’s part of our efforts to identify the right patient for the right treatment,” said Ruth Tal-Singer, PhD, GSK’s Vice President of Medicine Development Leader and Senior Fellow, Respiratory Research and Development, in the Owlstone Medical news release.
VOCs in breath will be captured in a non-invasive way from patients who wear Owlstone Medical’s ReCIVA Breath Sampler, which, according to Owlstone Medical, has CE-mark clearance, a certification noting conformity with European health and safety standards. The VOCs breath samples will then be sent to Owlstone Medical’s lab for high-sensitivity analysis.
“Non-invasive Breath Biopsy can establish a role in precision medicine applications such as patient stratification and monitoring treatment response,” said Billy Boyle, Owlstone Medical’s co-Founder and Chief Executive Officer.
VOC Biomarkers in Respiratory Disease
VOC profiles can be characteristic of COPD as well as other respiratory diseases including asthma, tuberculosis, and cystic fibrosis, reported Science/Business.
According to Owlstone Medical’s Website, VOCs are gaseous molecules produced by the human body’s metabolism that are suitable for Breath Biopsy. Their research suggests that exhaled breath reflects molecular processes responsible for chronic inflammation. Thus, VOCs captured through Breath Biopsy offer insight into respiratory disease biomarkers.
Breath also includes VOCs that originate from circulation, which can provide information on a patient’s response to medications.
How the Breath Biopsy Platform Works
Owlstone Medical’s platform relies on its patented Field Asymmetric Ion Mobility Spectrometry (FAIMS) technology, which “has the ability to rapidly monitor a broad range of VOC biomarkers from breath, urine and other bodily fluids with high sensitivity and selectivity,” according to the company’s website. During the process:
- Gases are exchanged between circulating blood and inhaled fresh air in the lungs;
- VOC biomarkers pass from the circulation system into the lungs along with oxygen, carbon dioxide, and other gases;
- Exhaled breath contains exiting biomarkers.
It takes about a minute for blood to flow around the body. So, a breath sample during that time makes possible collection and analysis of VOC biomarkers from any part of the body touched by the circulatory system.
The medical analysis is enabled by software in the Owlstone Medical lab, Boyle told the Cambridge Independent.
“There’s an analogy with blood prints—you get the blood and can look for different diseases, and we’ve developed core hardware and technology to analyze the breath sample,” he said.
Another Breath Sample Device
The ReCIVA Breath Sampler is not the only breathalyzer focused on multiple diseases. Dark Daily reported on research conducted by Technion, Israel’s Institute of Technology, into a breath analyzer that can detect up to 17 cancers, and inflammatory and neurological diseases.
But Owlstone Medical stands out due, in part, to its noteworthy partners: the UK’s National Health Service, as well as the:
And now the company can add collaboration with GSK to its progress. Though some question the reliability of breath tests as biomarkers in the areas of sensitivity and specificity required for cancer diagnosis, Owlstone Medical appears to have the wherewithal to handle those hurdles. It is a diagnostics company that many pathologists and medical laboratory professionals may find worth watching.
—Donna Marie Pocius
Related Information:
Owlstone Medical’s Breath Biopsy Platform Integrated into GSK’s Phase II Respiratory Disease Clinical Trial
GSK Utilizes Owlstone Disease Breathalyser for Key Clinical Trials
GSK Presents Respiratory Data from Pipeline to Clinical Practice at ERS
GSK Boosts Medtech First Owlstone with Use of Breath Biopsy in Respiratory Trial
Glaxo to Stratify COPD Trial Using Breath Biopsy Device
Billy Boyle of Owlstone Medical on the Inspiration Behind His Mission to Save 100,000 From Dying of Cancer
Owlstone Medical and UK’s NHS Study Whether Breath Contains Useful Biomarkers
Breath Based Biomarker Detection: Informing Drug Development and Future Treatment Regimes
Clinical Laboratories Could Soon Diagnose 17 Diseases with a Single Breath Analyzer Test from Israel’s Institute of Technology
May 11, 2015 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
If the clinical study validates this patient-friendly, non-invasive approach to diagnosing lung cancer, it could eventually mean fewer referrals of tissue biopsies to medical laboratories
For almost a decade, pathologists have seen a regular stream of news stories about technologies that utilize a sample of human breath to diagnose a disease or health condition. Now comes news that just such a diagnostic test for lung cancer is beginning clinical trials in the United Kingdom.
The clinical trials will evaluate breathalyzer technology developed by Engineer Billy Boyle, M.S., Co-founder and President of Operations at Cambridge-based Owlstone Ltd.. The clinical trials of this new breathalyzer technology to detect lung cancer are taking place at two National Health Service (NHS) hospitals: University Hospitals of Leicester and Cambridge’s Papworth Hospital in the United Kingdom.
The reason why so much research is happening in this field will be familiar to clinical laboratory managers and pathologists. Use of volatile organic compound (VOC) biomarkers in breath to diagnose disease is an ideal concept because it is convenient, non-invasive, and well tolerated by patients. However, until the start of this clinical study, researchers have explored the potential of this diagnostic approach for some time, but with limited success. (more…)
Sep 9, 2011 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology
Recent advances in breath analyzer technologies may give pathologists new diagnostic tools
Does breath analysis have a promising future in pathology and clinical laboratory testing? That day may not be far off. Scientists in multiple research laboratories are developing cost-effective, non-invasive diagnostic test technologies based on breath specimens from patients.
Researchers say that breath analysis can provide critical information in real time and deliver numerous advantages over fluid and image-based testing. In fact, glucose testing via breath specimen may be just around the corner!
On May 31, 2011, Xhale, Inc. was issued a patent for its system and method for non-invasive monitoring of glucose concentrations in blood to provide critical information in the diagnosis and treatment of diabetes. The Xhale system consists of a small handheld device that analyzes exhaled breath condensate. (more…)
Jul 9, 2010 | Laboratory News, Laboratory Pathology
Medicare to do National Demonstration Project Involving Medical Homes
Medical home pilot projects are being closely watched by pathologists and clinical laboratory managers. This is a new model of patient-centered care which has important advocates among primary care practitioners. If the medical home concept catches on, it may require clinical laboratories to provide laboratory testing services in a different way.
In southeastern Pennsylvania, a medical-home pilot project is taking a “do-it-yourself” approach to managing chronic illnesses. This project is viewed by some as a precursor to a national model. The innovative program, which combines the Wagner Chronic Care Model with the patient-centered medical home concept, provides physicians with resources to improve patient–doctor communications. The pilot project is also designed to educate willing patients on how to self-manage their chronic illnesses.
(more…)
