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Sleep and Respiratory Care Update

November/December 2016

Feature article

Philips-sponsored study shows great promise for improving quality of life for millions of patients suffering from COPD


Philips Respironics has announced preliminary results of an independent, multi-center Home Oxygen Therapy–Home Mechanical Ventilation, (HOT-HMV) study carried out by respiratory experts at St. Thomas’ Hospital in London. Preliminary study results released at the European Respiratory Society (ERS) International Congress 2016 reveal that patients using HOT with HMV are half as likely to be readmitted to the hospital.
The HOT-HMV study used a randomized controlled trial that compared the use of HMV and HOT therapies with HOT alone in 116 patients with persistent hypercapnia. Lead investigators included Dr. Nicholas Hart, professor and clinical and academic director of Lane Fox Respiratory Unit at St. Thomas' Hospital, Dr. Patrick Murphy, consultant physician at Guy’s and St. Thomas’ NHS Trust and honorary senior lecturer at King’s College London and their colleagues.
“Our goal with this study was to find a way to provide COPD patients with oxygen therapy, as well as home ventilators, in an effort to lower the number of patients being readmitted to hospitals,” said Dr. Hart. “The results of the HOT-HMV study have the ability to change the way COPD patients are treated worldwide. We’re looking forward to continuing the trial over the next five years to monitor survival rates, which we hope will rise, and readmission rates, which will hopefully fall.
This study began in 2010 using the BiPAP Harmony (Philips Respironics, not sold in the U.S.) and the VPAP3 S/T (ResMed). The study has been submitted for publication. At this time, only the abstract is available. Please note: HMV and Non-invasive ventilation (NIV) are used interchangeably.

Click on the tabs below to review details about the trial.

ABSTRACT: Home Mechanical Ventilation (HMV) Trial Following Life Threatening Exacerbations of COPD¹

¹ ABSTRACT--Home Mechanical Ventilation (HMV) Following Life Threatening Exacerbations of COPD: A UK Multicentre Randomised Controlled Trial (HoT-HMV Trial NCT00990132)

Respiratory therapists touch patients’ lives in home care 

By: Gail Watkins Varcelotti, Founder and Vice President of Ganesco, Inc. 

As we all know, the Affordable Care Act and other health care initiatives have encouraged health care providers to look for ways to improve outcomes in a time of declining reimbursements. But as these reimbursements decline, it’s still important to consider how we can increase efficiencies by providing care in the best environment, especially for patients with respiratory and sleep disorders.

The desired goal is to have a patient’s condition managed in the home without constant readmission to the acute care setting. This can be accomplished through the use of advanced technology and by offering convenient support inside the home.

Alongside home care patients are the respiratory therapists who are vital in helping them achieve independence and mobility and continue to participate with their family and the community. As the American Association for Respiratory Care noted during the 2016 Respiratory Care Week, respiratory therapists are real-life heroes. They provide outpatient treatment support that lead to improvement in activities of daily living, better maintenance of oxygen levels, diminished dyspnea and improved sleep.

When asked about her opinion of being a respiratory therapist in homecare, Lee Caporali, a RT with the Allegheny Health Network Home Medical Equipment in Pittsburgh, Penn. stated: “Homecare respiratory therapists are seeing patients in their home environment, educating how to reduce their symptoms and maximize their energy to maintain valued independence and improving their quality of life while in their home….and we get to work with one patient at a time.”

 

Echoing those benefits, Kim Wiles, RRT (also from Allegheny Health Network Home Medical Equipment) noted: “The value the homecare respiratory therapist brings to the patient is immeasurable. We are part of the patient’s solution to their healthcare at home. We provide education on equipment and their related disease states at the same time as providing the security they need to remain in their home.”

Other therapists mention how much they value the flexibility when they get to work with patients of different ages and clinical conditions, and how patients and therapists get satisfaction in seeing patients works to restore themselves to “normal” function, in the environment where it’s most comfortable and convenient — at home. It’s coordinated care at its best. Everyone benefits: the patient, the family, the physicians and specialists.

Ms. Gail Watkins Varcelotti is a founder and vice president of Ganesco, Inc. She has over 33 years of experience in the area of cardiopulmonary medicine education and most recently was the president of Education on the GO, a consulting service in development and training in health care topics and venues. In addition, she was an assistant professor and program director of Respiratory Care at Gannon University for 15 years and was also employed as a consultant and manager of Corporate Medical Education and Training for Respironics, Inc.

Sleep and Respiratory Care (SRC) medical education update

Three new online continuing medical education activities are now available on the CHESTTM Journal website in the CME Resource Center:

*Presentations available in German and English

COPD Advanced Patient Management: Post-acute care

  • Activity Three: Airway Secretion and Clearance with Jens Geiseler, MD.


Servo Ventilation Therapy for Sleep Disordered Breathing

  • Activity Two: Managing Sleep Disordered Breathing In Heart Failure with Winfried Randerath, MD.
  • Activity Three: Technology of Servo Ventilation with Michael Arzt, MD.

Transition care programs bridge healthcare gap to reduce hospital readmissions

Poorly executed care transitions negatively affect patients’ health, well-being and family resources while unnecessarily increasing health care system costs. For high risk patients and individuals with multiple chronic conditions, this transition takes on an even greater importance.¹ High risk patients are identified as one or more of the following: those admitted to the hospital twice or more in the last year, they or their caregivers may be unable to replicate equipment operation instructions after returning home, or patients who demonstrate low confidence in self-care at home.²

Curbing rehospitalizations is a large focus area for hospitals, especially when financial consequences accompany the estimated one third of chronically ill patients who will be readmitted within 30 days of being discharged.³

Care programs and partnerships bridge the gap in patient care from the hospital to home. These programs provide comprehensive discharge planning and home follow up, patient education, and most importantly, they identify avoidable health complications early-on, thus curbing the risk of rehospitalizations for high risk patients.⁴ Although this type of care occurs largely outside of the hospital, it starts in the hospital.²


Home healthcare services organizations are adopting quality measures to demonstrate their value proposition -- improved outcomes and lower readmission rates, especially for patients with conditions associated with high-rate readmissions, such as heart failure, COPD, pneumonia and diabetes. Measurements focus on emergency room visits, patient satisfaction, care giver competence, and patient compliance.²

Published research on successful transition care programs to home recommend a set of interventions introduced before and continued after discharge to be effective.² Patient and family engagement, alliance and collaboration among the care team (clinicians, staff and home healthcare organizations)² and patient monitoring are all important in a patient’s transitional care comprehensive plan.

Listed are some examples of evidence-based transition care programs outlining the factors above:²

1. Care Transitions Program

2. State Action on Avoidable Rehospitalizations (STAAR)

3. The Bridge Model - Geriatric Resources for Assessment and Care of Elders (Also known as Project Red)

4. Transitional Care Model

5. Better Outcomes for Older Adults Through Safe Transitions (BOOST)

6. Guided Care

References:

1. Rutherford et al. How-to Guide: Improving Transitions from the Hospital to Community settings to Reduce Avoidable Rehospitalizations. Cambridge, MA: Institute for Healthcare Improvement; June 2013.

2. Labson, M. Innovative and Successful Approaches in Improving Care Transitions From Hospital to Home. Home Health Now Feb 2015;33(2):88-95

3. Alliance for Health Reform. Covering Health Issues 2006-2007: Available at: http:www.allhealth.org/sourcebooktoc.asp?sbid=1.

4. www.evidencebasedprograms.org/1366-2/transitional-care-model-top-tier

A success story of an intervention care program:
Retrospective assessment of home ventilation to reduce rehospitalization in chronic obstructive pulmonary disease

 

A single center enrolled 397 patients in a quality improvement program. Patient criteria consisted of two hospitalizations in a single year with an acute COPD exacerbation, diagnosed with COPD GOLD stage 2-4, had a Bode Index Score ≥5, and one of the following: PaO2 ≤60 mm HG, PaCO2 ≥52 mm Hg, or FEV1 ≤40%. Prior to study 3.8% of the patients used Bi-Level support and 9.3% used CPAP.

Barnes Healthcare Services implemented a multifaceted intervention program consisting of: medication reconciliation, oxygen therapy, noninvasive pressure support (NIV) AVAPS-AE (using Trilogy 100, Philips Respironics, Inc.), patient education, and ongoing respiratory therapist-led care in the home. (All patients using Bi-Level Support or CPAP were switched to Trilogy AVAPS-AE for study)

Hospital readmissions following initiation of quality improvement program
Number of COPD-related Admissions
Patients with admission in the year prior to program initiation (n[%])
Patients with admission in the year post program initiation (n[%])
0
0 (0%)
348 (87.7%)
1
0 (0%)
40 (10.1%)
≥ 2
397 (100%)
9 (2.2%)
Admissions among the 397 COPD patients enrolled in the QI program. N (%), unless otherwise stated.

Primary outcome 


Patients who were readmitted on two or more occasions decreased from 100% (397 of 397) in the year prior to initiation of the intervention to 2.2% (9 of 397) in the following year (x2 758, p < 0.0001).* 

Reference:

Coughlin S et al. Retrospective assessment of home ventilation to reduce rehospitalization in chronic obstructive pulmonary disease.J Clin Sleep Med 2015;11(6):663–670.

 

* Seventy patients died over the one year following initiation of the multifaceted intervention. A composite outcome of rehospitalization and death was associated with inhaled steroids (adjusted odds ratio [adjOR] of 2.13; 95% confidence interval [CI] 1.09, 4.17; p = 0.02), whereas inhaled antimuscarinics tended to be associated with less risk for rehospitalization or death (adjOR 0.56; 95% CI 0.34, 1.03; p = 0.06).

Clinical Research: A brief interview with Gary Lotz, Philips Director of Clinical Research 

Clinical research propels advancements within our industry and its data serves as the anchor on which legal, marketing and regulatory departments must base their claims. Gary Lotz, Philips Director of Clinical Research, has managed all aspects of clinical research projects for more than 15 years.

 

In the Q&A below, Lotz shares an overview of clinical research and what is on the horizon for the Philips Sleep & Respiratory Care team.

What is clinical research?


Gary Lotz
: Clinical research is the process of collecting generalizable data to support the development and implementation of new products or solutions for various diseases or conditions.

Clinical research at Philips Sleep and Respiratory Care generally involves human participants. Our Clinical and Scientific Affairs (C&SA) team produces clinical evidence that helps translate research results into new treatments and information to benefit patients.

What laws and regulations are important to consider in clinical research?


Gary Lotz:
There are many laws, regulations and best practices for clinical guidance that must be understood and followed to successfully execute and obtain valid / quality clinical research data. Key regulations include:

 

  • ISO 14155
  • 21CFR’s – 11, 50, 54, 56, 812, 820
  • ICH (International Council for Harmonization) Guidance
  • MDD/MDR
  • HIPAA
  • Philips Global Business Principles (GBP’s)
    - Code of Conduct
    - Anti-Kickback Statute
    - False Claims Act
    - Sunshine Act

What are linkages and why are they important?


Gary Lotz
: Clinical research touches almost every department within this business in one way or another. We call these interconnections linkages. Most often, linkages include interaction with teams in regulatory, quality, engineering, marketing, as well as the executive leadership team.

Regulatory reviews the status of the investigational products, assesses the need for supporting data for marketing submissions or technical details. Quality teams handle product testing against established standards. Engineers create or modify product that will be used in trials. On the marketing side, the C&SA and clinical marketing team meet with the product managers to discuss claims. The executive team oversees the portfolio management.

What is on the horizon for clinical research at Philips?


Gary Lotz
: Philips’ Sleep and Respiratory Clinical & Scientific Affairs team has recently become centralized within the HealthTech Regulatory and Clinical Affairs group. They are constantly evaluating new clinical and data management processes, and are vital participants in leading deployment efforts to harmonize these processes across all of Philips HealthTech. These processes are intended to support the many aspects of designing and executing clinical trials, from initial discussions to final study reports and publications. This is a long and sometimes arduous process that requires a lot of support, professional character, as well as persistence and patience.

Whoopi Goldberg kicks off “Breathe Boldly”, a Philips’ COPD awareness initiative 

On World COPD Day, Philips launched the Breathe Boldly social initiative with the support of the COPD Foundation and the daughter and son-in-law of the late Leonard Nimoy, who died of COPD in 2015. Join us in breathing boldly by posing a selfie of an activity while breathing through a straw. Tag your friends and include the hashtag #BreatheBoldly for #COPD in your post to show empathy and support for those living with COPD.

“We’re hopeful that Breathe Boldly will not only increase global awareness of the disease, but also helps people better identify symptoms of COPD, and gain a better understanding of what it is like to live with this disease that impacts so many people worldwide” said John Frank, General Manager Philips Sleep & Respiratory Care.

To learn more about this social initiative, please visit Philips.com/WorldCOPDDay.

Traveling with Oxygen: Top tips to share with your patients

Any travel takes planning, but add portable oxygen needs, and a simple trip to visit family and friends becomes more complicated than just booking a ticket and arriving on time. Patients with portable oxygen needs should discuss their travel plans with their doctors and check with the approriate travel representatives to ensure oxygen needs are met while complying with set travel guidelines. The following tips are important to consider:

1. Contact your travel carrier (airline, cruise ship, or bus company) several weeks in advance to understand the requirements for traveling with oxygen. Airlines and cruise ships will not allow passengers to bring oxygen cylinders or tanks on board.
 

2. Ask your doctor if you need to change the oxygen settings at any time during your trip, especially during air travel or on destination at a high altitude.

3. Consider getting a portable oximetry device for the trip.

4. Gather all necessary paper work (medical history/insurance cards/medical certificate of POC use, medical emergency information) and a copy of your oxygen prescription including liter flow and duration.
 

5. Contact your home healthcare company. Let them know where you are traveling and how. They can help make arrangements for oxygen at your new destination.

References

1. ©2013 Koninklije Philips N.V. All rights are reserved. Geyer WMB 07/28/13 MCI 4105753 PN 1112007

2. "Portable Oxygen Concentrators." Traveling with Portable Oxygen Concentrators. United Airlines, 2016. Web. 07 Nov. 2016.

3. "Tips for Traveling with Portable Oxygen Concentrators." www.oxygenconcentratorstore.com. American Medical Sales and Rentals, 2016. Web. 7 Nov. 2016. 

We at Philips Sleep and Respiratory Care wish you and yours a happy and safe holiday season.