INFORMATION ON THE COVID-19 VACCINES

12/16/20

For this post, the Department of Quality and Safety asked George X. Huang, MD, a fellow in the Division of Allergy and Clinical Immunology, and Paige Wickner, MD, MPH, a faculty member and the head of Quality and Safety for the Division of Allergy and Clinical Immunology at Brigham and Women’s Hospital, to provide information about the Pfizer-BioNTech COVID-19 vaccine.

On Dec. 11, 2020, the U.S. Food and Drug Administration (FDA) approved an Emergency Use Authorization for the COVID-19 vaccine produced by Pfizer and BioNTech to be distributed in the United States to those ages 16 and older.1 This vaccine (which is called BNT162b2) is delivered via two injections to the arm muscle which are given three weeks apart. The vaccine works by using advanced technology to deliver an RNA molecule to the body, which then instructs it to make a modified version of the spike protein of the SARS-CoV-2 virus.

Although researchers have been studying them for many years, this is the first RNA-based vaccine to be approved in the U.S. RNA-based vaccines are generally considered safer than other vaccines as they are not produced using any infectious virus elements, and the benefits of RNA-based vaccines are the same as all other vaccines: those vaccinated gain protection against certain infectious diseases. Moderna, another biotechnology company, has also produced an RNA-based COVID-19 vaccine that is currently under review by the FDA.

To study their vaccine’s safety and efficacy, Pfizer conducted clinical trials which included over 43,000 participants from several different countries including the U.S., Argentina, Brazil, and South Africa. Data from these trials showed that the vaccine prevented 95 percent of COVID-19 infections compared to participants who received a “fake” vaccine, also known as a placebo.2

There will certainly be further developments as other companies’ COVID-19 vaccines undergo review by the FDA. At the Brigham, we are closely following all data related to these vaccines, including their efficacy and safety. We have put measures in place as we begin vaccinations to ensure the safety of our patients and staff. Based on recommendations by the Centers for Disease Control (CDC), and in alignment with the state’s approach to vaccine distribution, we have begun vaccinating eligible health care workers this week.

For additional information on COVID-19 vaccines, please reference the links below in addition to consulting state-specific guidelines:

References:

    1. U.S. Food & Drug Administration. Pfizer-BioNTech COVID-19 Vaccine. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine
    2. Polack et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N  Engl J Med. 2020. PMID: 33301246

 

Making the Invisible, Visible: Identifying Victims of Intimate Partner Violence

11/16/20

For this post, the Department of Quality and Safety asked Bharti Khurana, MD, founding director of the Trauma Imaging Research and Innovation Center, and Assistant Professor at Harvard Medical School, to talk about her groundbreaking project that works to more quickly and easily identify victims of intimate partner violence (IPV) based on imaging results.

Did you know? Approximately 1 in 4 women and 1 in 7 men report experiencing some form of intimate partner violence (IPV) at some point in their lives.1 Launched by the Brigham and Women’s Physicians Organization in 2013, the Brigham Care Redesign Incubator and Startup Program (BCRISP), works to improve the care we provide to our patients across the Brigham with the goal of solving leading healthcare challenges, such as IPV. BCRISP invests in proposals led by front-line clinicians, facilitates testing of promising ideas, scales successful projects and creates programs that deliver clinical, operational and financial value. The program has engaged every clinical department across our hospital and has sponsored 74 pilots over the past seven years.

In its most recent cohort, BCRISP supported a project led by Dr. Khurana, a radiologist at the Brigham, entitled “Making the Invisible Visible: Intimate Partner Violence.” As research on the COVID-19 pandemic continues to show increased rates of IPV nationwide,2 this work on early and more streamlined identification of IPV has become even more critical.

This project started because Dr. Khurana realized that while radiologists can easily identify child abuse, there were still opportunities for identifying adult cases of intimate partner violence. With a background in both trauma identification and artificial intelligence, Dr. Khurana began thinking about how to incorporate artificial intelligence into adult IPV identification.

Through BCRISP and additional funding, Dr. Khurana and her team have reviewed numerous images of patients who have experienced IPV. Based on patterns they have identified, they are in the process of creating an algorithm to more easily spot victims and, ultimately, give them the resources they need to prevent future harm. Dr. Khurana is partnering with the Massachusetts Institute of Technology on the development of the algorithm and it is her hope that it will be completed by the end of 2021. The team is optimistic that this algorithm will inform standard clinical care at the Brigham and be helpful to hospitals and patients nationwide.

Example radiographic images of patients who have experienced IPV; taken with permission from the Trauma Imaging and Research Innovation Center and Bharti Khurana. Patient photos have been deidentified.

If you or someone you know is experiencing Intimate Partner Violence (IPV), please reference these resources to seek help:

For more information on BCRISP, please email the team at BCRISP@partners.org. In addition, you can find a recent publication on the program here.

To hear more about the work that Dr.  Khurana and her colleagues are working on around IPV, please reference the following publications and websites:

References:

  1. Breiding, MJ. Black MC. Ryan GW. Prevalence and Risk Factors of Intimate Partner Violence in Eighteen U.S. States/Territories, 2005. American Journal of Preventive Medicine. 2008 Feb. PMID: 18201640.
  2. Evans, ML., Lindauer, M., Farrell ME. A Pandemic within a Pandemic- Intimate Partner Violence During COVID-19. New England Journal of Medicine. 2020 Sept 16. PMID: 32937063.

 

Bringing Frontline Staff to the Forefront of Quality and Safety Improvement

10/13/20

For this post, the Department of Quality and Safety asked one of our team members, Casey McGrath, RN, MSN, senior director of Clinical Quality Improvement, to discuss Brigham Health’s latest project to engage frontline staff in hospital-wide quality improvement and patient safety initiatives.

As a large academic medical center, our employees pride themselves on having innovative ideas. On a daily basis you can hear chatter amongst staff across the hospital as they discuss “light-bulb moments” about new ideas on how best to care for a patient, identify opportunities to improve our workflow and processes, and one of the latest new research projects.

It is well-established in patient safety research that these frontline staff members, those who are responsible for caring for patients at the bedside, are key to identifying hazards in the workplace and proposing the best ways to eliminate them.1 However, it can be challenging to translate the ideas of frontline staff into action. This problem is not specific to Brigham Health; it is something large academic medical centers and hospitals face throughout the country. Recognizing this problem, many academic medical centers have created unit-based team (UBT) structures, allowing frontline staff to be closely involved in continuous patient safety and quality improvement.1,2 This past summer, Brigham Health began the process of launching our own UBT system across our inpatient floors. As part of the UBT model, frontline staff are paired with members of hospital administration and other key stakeholders with the goal of having staff feel empowered to ensure their voices are heard and they are engaged in changes and improvements in the work they do every day to care for patients.

Our UBTs meet weekly and focus on key hospital patient safety and quality improvement initiatives (e.g. catheter-associated urinary tract infections, central line-associated bloodstream infections, hand hygiene, patient satisfaction) as well as local quality, safety and operational metrics. The team reviews data, discusses concerns and identifies and implements improvement initiatives. Currently, BWH has seven active UBTs and is working on expanding to other inpatient units throughout the hospital. By providing units with a standardized structure for identifying concerns, improving performance and sharing ideas, as well as administrative support to assist with designing and implementing improvement initiatives at the frontlines of care, we hope to turn these “light-bulb moments” into reality so that the Brigham and its staff can continue to provide the safest and highest-quality care to patients and their loved ones.

References:

  1. Pottenger, BC., Davis, RO., Miller, J., Allen, L., Sawyer, M., Pronovost, PJ. Comprehensive Unit-based Safety Program (CUSP) to Improve Patient Experience: How a Hospital Enhanced Care Transitions and Discharge Processes. Quality Management in Health Care. 2016 October/December.
  2. Kim CS., King E., Stein J., Robinson E., Salameh M., O’Leary K. Unit-based Interprofessional Leadership Models in Six US hospitals. Journal of Hospital Medicine. 2014 May.

COVID-19 Contact Tracing at Brigham Health

8/21/20

Throughout the COVID-19 pandemic, contact tracing has played a critical role in preventing the virus’ spread. Historically used for several other infectious diseases, contact tracing has been shown to be especially important at the early stages of an outbreak when there is scarce information about the disease and treatments are not yet available.1  Given how little was known about COVID-19, particularly early in the pandemic, the Brigham’s rapid ability to create its own COVID-19 contact tracing program was critical to ensuring our patients and staff remain safe as possible.

According to the Centers for Disease Control and Prevention, contact tracing consists of three main steps:2

  1. Letting people know they may have been exposed to COVID-19 and should monitor their health for signs and symptoms of COVID-19.
  2. Helping people who may have been exposed to COVID-19 get tested.
  3. Asking people to self-isolate if they have COVID-19 or self-quarantine if they are a close contact.

Brigham Health’s Occupational Health, Infection Control and Quality and Patient Safety teams came together early in the pandemic to create a process by which each of these contract tracing steps could be accomplished within our hospital and community so that possible COVID-19 exposures are identified and communicated, and patients and staff with possible exposures are supported as much as possible. The communication strategies we have undertaken have even been published in The Joint Commission Journal on Quality and Patient Safety. Additional details on our health care staff communication strategies can be found here, and patient communication strategies here.

Through our program, any patient or staff member who tests positive for COVID-19 within the Brigham Health system is thoroughly reviewed for possible exposures. Interviews are conducted with all staff with confirmed positive test results and any possible employee or patient exposures are identified.

Additionally, all patients who test positive at a Brigham Health site, either at the hospital or at an ambulatory clinic, have manual reviews performed of their medical record to identify any possible exposures to COVID-19 that may have occurred. Exposures are also analyzed using a medical record tracing function, allowing Infection Control to identify staff who interacted with the patient and subsequently may have been exposed.

Once any possible exposure risks are identified, staff are contacted by Occupational Health, and patients received a phone call from a physician. The physicians ensure all patients’ questions and concerns are addressed and that appropriate resources, such as social work and communication with the patient’s primary care provider, are offered. Staff and patients are also educated on the latest Centers for Disease Control and Prevention recommendations around symptom monitoring and isolation precautions and are given assistance and information on how to get testing.

We firmly believe that our efforts to implement contact tracing within our hospital helped to prevent countless additional infections from occurring. As the pandemic is ongoing, we are committed to ensuring this process continues and that transparency and the safety of our staff and patients remains our highest priority.

References:

1Keeling, MJ., Hollingsworth, TD., Read, JM. Efficacy of Contact Tracing for the Containment of the 2019 Novel Coronavirus (COVID-19). J Epidemiol Community Health. 2020 Jun 22. PMID: 32576605

2Centers for Disease Control and Prevention. Notification of Exposure: A Contact Tracer’s Guide for COVID-19.

https://www.cdc.gov/coronavirus/2019-ncov/php/notification-of-exposure.html

A Near Miss, An Important Reminder

7/23/20

While the COVID-19 pandemic continues to pose a significant global health threat, one recent near-miss patient safety event at Brigham and Women’s Hospital was a reminder of the need for continued focus on all public health issues, transparency and our culture of safety.

According to the U.S. Department of Health and Human Services, over 130 individuals die daily from opioid-related drug overdoses across the country, with over 10.8 million Americans misusing prescription opioids in 2018.1 In 2017, the opioid crisis was declared a public health emergency and efforts have been ongoing to, among other things, reduce the number of opioid prescriptions written overall, as well as reduce the number of opioid pills ordered per prescription. Research shows that electronic medical records, computer systems used to manage patients’ information while at the hospital, may make the issue of overprescribing opioids worse by setting automatic suggestions for the number of pills doctors should prescribe following certain procedures.2

In June of this year, one of our General Surgery residents experienced this problem when ordering opioids for several of his patients in our electronic medical record system. When prescribing oxycodone, an opioid typically prescribed for severe pain management, like that experienced after surgery, the pre-populated quantity in the electronic medical record prescription suggested he order 450 pills, far more pills than necessary, rather than the five he originally intended to prescribe. Concerned that this suggestion would result in his patients receiving many more pills than they needed, and aware this can put patients at an increased risk for addiction, overdose and even death,3 he alerted the Information Technology, Pharmacy, and Patient Safety teams so they could work to eliminate this automatic suggestion. The teams worked quickly, and within 10 hours, the issue was fixed not only at our organization, but across all hospital systems that use the same technology.

We are grateful that we can consider this event a “near miss” in which no patients received more opioid pills than they needed. We are fortunate to have a culture of transparency in which this physician was willing to speak up about the patient safety issue he identified.

References:

1U.S. Department of Health and Human Services. What is the Opioid Epidemic? https://www.hhs.gov/opioids/about-the-epidemic/index.html.

2Makary, MA., Overton, HN, Wang, P. Overprescribing is a Major Contributor to Opioid Crisis. BMJ. 2017 Oct 19. PMID: 29051174

3Centers for Disease Control and Prevention. 2018 Annual Surveillance Report of Drug-Related Risks and Outcomes — United States. Surveillance Special Report.

https://www.cdc.gov/drugoverdose/pdf/pubs/2018-cdc-drug-surveillance-report.pdf.