Patient Registry Tracking COVID-19: ELSO and Extracorporeal Membrane Oxygenation (ECMO)

Patient Registry Tracking COVID-19: ELSO and Extracorporeal Membrane Oxygenation (ECMO)

Patient Registry Tracking COVID-19: ELSO and Extracorporeal Membrane Oxygenation (ECMO)

As we face the continually evolving pandemic of COVID-19, each day brings new challenges and opportunities to learn from our shared experiences. This education is fueled by the hard work and dedication of individual clinicians, care teams, research institutions, and medical specialty societies around the globe.

Coordinated efforts by medical societies and their members have a real impact on our ability to fight against the pandemic. These organizations support the collection, analysis, and proliferation of data about this virus at a global scale.

A global crisis needs global collaboration for a global solution.

ECMO Is Proven to be Effective Treatment for COVID-19 Patients with Severe Respiratory Distress

COVID-19 (the illness caused by the novel coronavirus) causes severe respiratory distress in some patients. Extracorporeal Membrane Oxygenation, commonly referred to as ECMO, is a treatment that uses an artificial heart and lung to support the body when a person's own organs are too sick to do the job. ECMO itself will not cure a patient’s heart or lungs, but it gives them the time needed to heal.

ECMO has proven to be an effective treatment for COVID-19 patients with severe respiratory distress. In addition to ECMO being an effective therapy in the treatment of severe Acute Respiratory Distress Syndrome (ARDS), it is a recommended rescue therapy in COVID-19 patients in guidelines published by the Society of Critical Care Medicine.

Global ECMO Organization Tracks and Educates on COVID-19

The leading global authority on the use of ECMO is the Extracorporeal Life Support Organization (ELSO). Its global patient registry is the world’s largest source of data on patients receiving ECMO. ELSO typically supports medical research, continuing education, guidelines development, and device surveillance.

ELSO is uniquely positioned to lead education efforts around the use of Extracorporeal Life Support (ECLS) and ECMO as a treatment for COVID-19 patients. Dr. Mark Ogino, president of ELSO, said in a recent video summarizing ELSO’s COVID-19 response:

“We remain a real-time authoritative resource because of ELSO’s global member centers, which provide up-to-date information and data to allow our physicians and scientists to continually edit our recommendations.”

ELSO Registry Tracking ECMO for COVID-19

ELSO provides support to institutions delivering ECLS through the maintenance of a comprehensive registry of patient data. The ELSO Registry tracks the use of ECMO as a life-sustaining therapy in patients with severe cardiac or pulmonary distress. The registry tracks patient outcomes and complications occurring during ECMO for patients across a wide variety of clinical presentations and geographic areas. Registry data is not only used for publication, but also for benchmark reporting so that participating ECMO programs can see how their outcomes compare to average.

ELSO is waiving participation fees for new institutions and sites that would like to participate in these important tracking efforts. Get started here.

ECMO COVID-19 Resources

ELSO has organized resources and collected data from member centers across the world. Each resource shares the lessons learned in the parts of the world most affected by COVID-19.

Top ECMO resources for COVID-19:

ELSO’s coordination and leadership allows physicians and care teams working in areas hit hardest by the pandemic to share best practices, clinical guidelines, and recommended clinical indication and contra-indication for ECMO. This type of open collaboration helps improve care for all.

In addition, ICUs in Italy and China have released checklists aimed at limiting exposure to the virus by physicians during intubation. The coronavirus can spread through aerosol and moisture droplets, so it is especially important to limit physician exposure before, during, and after ECMO.

Global Study on ICU Management of COVID-19 Patients

One of the most important projects being undertaken by ELSO centers and physicians is the Extracorporeal Membrane Oxygenation for Coronavirus 19 Acute Respiratory Distress (ECMOCARD) Study. ECMOCARD is a study coordinated by the Asia-Pacific Chapter of ELSO with 104 participating hospitals across 5 continents and 26 countries.

ECMOCARD is currently the only global study to gather data on the ICU management of the sickest and most vulnerable COVID-19 patients. The ECMOCARD study will be an invaluable resource to manage the treatment of COVID-19 patients. In a time when so much is unknown, the value of rigorously documenting and disseminating the lessons learned every day is of immeasurable value. In the words of ELSO’s founder Dr. Robert Bartlett, “Our most important weapon in this crisis is data to predict and plan – on a global scale.”

At a time when each day bring new and unique challenges, it is more important than ever to collect, document and share experience globally; for in an increasingly interconnected world only through cooperation and solidarity can we overcome a global pandemic.

To stay up to date on the latest information regarding the use of ECMO for COVID-19, visit https://www.elso.org/COVID19 and follow ELSO on Twitter at @ELSOOrg.

If you have any questions or would like to learn more about clinical data registry software, contact me at lleon@arbormetrix.com.


Top Examples of Quality Improvement through Clinical Registries

Top Examples of Quality Improvement through Clinical Registries

Top Examples of Quality Improvement through Clinical Registries

Achieving real-world quality improvement in healthcare delivery benefits everyone. Patients have improved outcomes and a higher quality of life. Physicians use evidence-based insights to make decisions and advance care. Hospitals and payers achieve efficiencies and greater savings.

This win-win-win of quality improvement can be achieved locally with the right infrastructure, data, processes, and people involved. But what happens when many institutions come together to collaborate, share data, and learn from one another?

Improvements are achieved at greater scale. More people benefit. Today's biggest issues facing patient safety and outcomes are addressed.

Let’s look at the top examples of quality improvement at scale and how they achieved it: One from a regional surgical quality collaborative and another from a national network of pediatric hospitals with cardiac ICUs. Both use healthcare analytics and clinical registries to achieve significant results.

Example 1: Post-surgical Patient Opioid Consumption Drops by 50%

The opioid epidemic is a top priority for physicians and healthcare providers across the continuum of care. This is especially true in surgery. Surgeons prescribe 10% of opioids across the United States, and research shows “the vast majority of these pills are not used, potentially leading to opioid dependence, misuse, or diversion into the community." [1]

With this issue top of mind, in partnership with Michigan OPEN, the Michigan Surgical Quality Collaborative (MSQC) successfully launched a program to reduce the number of opioids prescribed to surgical patients over a 16-month time frame. [2]

The project involved researchers at Michigan OPEN developing evidence-based prescribing guidelines for five operations, based on MSQC-collected data on patient-reported opioid consumption after surgery. MSQC’s registry collected opioid prescribing, consumption, and satisfaction data for more than 10,000 patients over several months. They transformed this data into knowledge and defined and disseminated new opioid prescribing guidelines. Then they continued to collect data, and track and analyze outcomes.

Did the new guidelines make a difference? The results published in the New England Journal of Medicine were clear. They found:

  • A 30% decrease in post-operative opioid prescribing.
  • A 50% decline in post-operative opioid consumption.
  • No change in patient-reported satisfaction with care and pain in the week after surgery.

How did they achieve it?

Reaching these outcomes required MSQC’s deliberate planning, coordination and collaboration, and information and data sharing.

Data-Driven and Patient-Centric Program Design

MSQC organized this initiative and leveraged their infrastructure exceptionally well:

  1. They used existing research and new data to understand the problem and inform the program.
  2. They used real-time analytics to accelerate findings.
  3. They included patient-reported outcomes and satisfaction after surgery.

Their post-surgical opioid prescribing reduction program is best summarized an excerpt from a recent paper:

“Opioids prescribed after surgery have gained national attention for their role in the escalating opioid epidemic.14, 15 To learn about this problem, the MSQC team sought feedback from the collaborative sites, reviewed scientific and practice‐based research, and solicited patient experiences. With this knowledge, the MSQC clinical leadership designated postsurgical opioid prescribing as a quality improvement focus area with high priority. The coordinating center team added additional data collection variables to the MSQC data platform to determine the amount of opioids prescribed after surgery. They also added patient‐reported opioid consumption, and other patient‐reported outcomes including satisfaction with care and postoperative pain. Data were collected on a subset of patients undergoing five of the most commonly performed operations in the MSQC database.” [2]

Flexible and Robust Data System

MSQC’s clinical data registry on the ArborMetrix platform plays a central role in all of its quality improvement programs.

Along with its community 70 hospitals, MSQC uses real-world data to focus relentlessly on achieving real-world quality improvement and make Michigan the best place for surgery in the country. Their approach and proven results have made them a national example of how to advance care and reduce costs using high-integrity data. [3]

The post-surgical opioid prescribing reduction program is no different. For this initiative, MSQC leveraged registry technology that:

  • Captures patient feedback after surgery and connects longitudinal data to specific procedures.
  • Provides real-time data in reports to enable a rapid research cycle. This allowed them to know early on whether the new guidelines were working right away. They didn’t have to wait a year or longer.
  • Easily supports the addition of new data collection variables — both from clinical sources and patient-reported outcomes.
  • Flexibly allows for the creation of new reports and dashboards.

Physician Engagement and Performance Feedback

Another central part of MSQC’s model is sharing performance feedback with surgeons and sites through the registry, and giving participants the tools they need to be successful.

  • The registry’s real-time, risk-adjusted reports give personalized performance feedback at the hospital and surgeon level. Participants can easily view their performance in comparison to other member institutions, drill down into specific use cases and patients for deeper evaluation, and export the full dataset for further analysis and research.
  • MSQC’s tool kits provide a “comprehensive ‘one-stop’ information hub” to participants to simplify and disseminate program guidelines.

Example 2: Critical Pediatric Cardiac Deaths Decrease by 24%

Nearly 40,000 infants born in the United States each year have some form of congenital heart disease (CHD), making it the most common birth defect affecting 1 in every 110 babies.

Pediatric cardiologists and researchers have improved outcomes considerably over the past few decades. Yet many children still experience significant health issues over the course of their lifetimes, according to Michigan Medicine C.S. Mott Children’s Hospital. [4]

New approaches are necessary to make the next leap in CHD care.

A group of physicians and researchers, led by Jeffrey Anderson, M.D., M.B.A., Michael Gaies, M.D., M.P.H., and Sara K. Pasquali M.D., M.H.S., organized Cardiac Networks United to address these challenges. Member institutions span more than two thirds of all hospitals caring for congenital heart patients in the United States. [5]

The Pediatric Cardiac Critical Care Consortium (PC4) is one of five founding organizations of CNU. PC4 aims to improve the quality of care for pediatric heart patients through transparent data sharing that allows hospitals to evaluate their own outcomes and learn best practices. [6]

Their efforts are proving effective and the results are outstanding.

Eighteen hospitals significantly reduced mortality and improved care for children with critical heart conditions, according to a paper published in the December 2019 edition of the Journal of the American College of Cardiology. The study analyzed more than 19,000 hospitalizations that included cardiac surgery at the participating sites in the PC4 registry. [7]

Published results include:

  • 24% decrease in postoperative mortality among participating sites between 2014 and 2018.
  • 12% reduction in major complications.
  • 13% decline in time on a ventilator.
  • 5% decrease in length of stay in the ICU.

How Did They Achieve It?

The core principles of collaborative quality improvement drive PC4 and its member community:

  • Purposeful collection of specific clinical data on outcomes and practice.
  • Timely performance feedback to clinicians.
  • Continuous improvement based on empirical analysis.
  • Collaborative learning at various events throughout the year.

Member organizations are committed to sharing data and expertise with one another to accelerate discovery and improvement in the care of patients with pediatric and congenital heart disease.

High Quality, Research-Grade Data

In order to achieve the level of trust and accuracy needed for collaborative quality improvement, PC4 puts a huge emphasis on the quality of the data in its registry. It focuses on three key aspects:

  • Streamlined data collection.
  • Immediate data quality feedback.
  • Routine site audits.

Real-Time Performance Feedback to Clinicians

PC4’s registry provides 24/7 access to real-time data to be used for local quality improvement. Participating hospitals use the registry to support their own physicians and care teams. Importantly, PC4 offers access to unblinded center data to facilitate identification of top performing hospitals and stimulate collaboration among sites to improve patient outcomes.

Tailored Analytics

Another key aspect driving PC4’s success are the powerful analytics behind its registry. Participants have access to risk- and reliability-adjusted comparative analyses on quality metrics selected by the consortium.

Recently of note, ArborMetrix helped develop a program-level risk adjusted metric on post-operative mechanical ventilation, measuring quality of care from the time a patient enters the OR to the end of their critical care period(s). This metric is part of PC4’s initiative to liberate children from the ventilator.

Registries Make it Possible

Organizations like PC4 and MSQC are the best examples of quality improvement through clinical registries. They show what is possible when you make a clinical data registry rooted in data science your hub of information to support collaborative data sharing, learning, and progress.


Top 3 Takeaways from the 2020 CMS Quality Conference

Top 3 Takeaways from the 2020 CMS Quality Conference

Top 3 Takeaways from the 2020 CMS Quality Conference

Last week, the Centers for Medicare and Medicaid Services (CMS) held its annual Quality Conference in Baltimore, MD. More than 3,000 attendees convened to learn and talk about the present and innovative future of quality improvement on a national scale. Leaders from CMS discussed the current administration’s rapidly-evolving quality agenda.

CMS Administrator Seema Verma outlined key priorities including:

  • Establishing clear and reasonable standards and quality measures, “the rules of the road”.
  • Strengthening the government’s oversight of said standards.
  • Promoting “transparency, competition, and consumer choice” by sharing more information with the public.
  • Modernizing “quality improvement efforts for all” via advances in data analytics and technology.

Three themes clearly emerged.

The Future of FHIR is Bright

CMS is serious about harnessing FHIR to ease the reporting burden for stakeholders. They have taken concrete steps toward a FHIR-based connectivity standard over the past year.

CMS is envisioning a centralized submission solution for quality reporting. This single, FHIR-based CMS receiving system will do all the calculations and exchange data and results with the appropriate quality programs. FHIR will enable future submissions to CMS be less complex. A successful pilot connection with Cerner earlier this year gives CMS confidence in its vision.

This move means great things for medical specialty and patient registries in particular. ArborMetrix uses a FHIR-based infrastructure to promote industry standards and support interoperability. This provides flexibility, efficiency, and scalability for the future. Organizations that focus on interoperability among their source data systems and data assets will have a tremendous advantage and unparalleled information access as initiatives like the one above – and others involving EHRs – are fully in place.

The Voice of the Patient Will Be Heard

Dr. Michelle Schrieber, CMS Director for Quality Measurement and Value Based Incentives, described the addition of patient-reported outcome (PRO) measures to the “Meaningful Measures 2.0” framework and the Merit-Based Incentive Payment System (MIPS).

Patient-reported outcome measures not only unleash the patient voice, but also minimize the burden in data collection. At a time when CMS is looking to reduce the number of MIPS measures overall, they are also looking to increase the number of PRO measures. This reflects their overall shift from process to outcomes measures that lean more heavily on the patient.

ArborMetrix believes patient data is invaluable. But using it requires the right strategy and healthcare analytics technology to be sustainable. PRO response rates are highest when used in shared decision making or when you empower the patient to view and engage with their own data.

Overall, it is clear CMS’s focus on PRO data will benefit organizations who have the technical and nuanced experience in longitudinal patient follow up.

Digital Quality Measures Will Simplify Everything

Representatives from CMS made the bold claim that by 2030, all quality measures will be fully digital. This means clinicians will not have to take time away from patient care to comply with quality programs. This is major progress.

CMS encouraged conference attendees to imagine a world where quality data is seamlessly transmitted from EHRs. This future state is exactly what is needed. Clinicians will finally be unburdened and everything they have to do will blend easily into their workflow—what they have spent years asking for.

ArborMetrix welcomes this transition, as it will amplify our medical specialty society partners’ goals to continue to go beyond MIPS when defining their strategic registry goals, measures, and programs. Our partners who have leveraged their registries to do the most impactful work, harness the collective power of their membership to embark on novel research efforts and quality initiatives that save lives. We look forward to helping medical specialty societies clarify their clinical data registry strategy and continue to improve patient outcomes.

The 2020 CMS Quality Conference was a whirlwind of data, presentations, and bold goals. The future of quality improvement that keeps patients at the forefront, embraces FHIR standards, and make QI compliance simple for clinicians, is one that I am really fully ready to embrace.