Tag Archive for: PCORI

doctor listening to patients heart

Children’s National leads patient-centered study of adult congenital heart disease

doctor listening to patients heart

The team will work with the 14 research institutions across the United States to collect data and then examine rates of complications or associated illnesses, as well as how adult patients have accessed health care throughout their lives.

Investigators at Children’s National Hospital and the Louisiana Public Health Institute are leading a $4.9 million research effort to study how gaps in health care affect the health and well-being of adults with congenital heart disease (CHD), supported by the Patient-Centered Outcomes Research Institute (PCORI).

The research is led by Anitha John, M.D., Ph.D., medical director of the Washington Adult Congenital Heart Program at Children’s National Hospital and Thomas Carton, Ph.D., chief data officer at the Louisiana Public Health Institute, as well as two patient co-investigators, Ruth Phillippi and Scott Leezer. The study leads also include representatives from the Adult Congenital Heart Association and Anu Agarwal, M.D., who represents the University of California – San Francisco (UCSF).

“With the increasing number of adult patients with CHD, it is important for us to understand how current recommended practices influence patient outcomes,” says Dr. John. “This project will guide us on how to best care for our patients, not just through childhood, but across their entire lifespans. Most importantly, this project will involve direct outreach to patients, incorporating patient reported outcomes as a measure of long-term outcomes.”

Together, the team will work with the 14 research institutions across the United States to collect data and then examine rates of complications or associated illnesses, as well as how adult patients have accessed health care throughout their lives. The findings may help predict which patients are at greater risk of falling out of routine health care, and when these gaps in care are likely to occur across a patient’s lifespan. The study will also correlate findings with how patients are actually feeling in their everyday lives.

The 14 participating institutions are:

  • Ochsner Health
  • Children’s Hospital of Philadelphia
  • Icahn School of Medicine at Mount Sinai
  • University of California – San Francisco
  • Nationwide Children’s Hospital
  • Duke University Health System
  • NYU Grossman School of Medicine
  • Nicklaus Children’s Hospital
  • Children’s Hospital Colorado
  • University of Miami
  • Columbia University Irving Medical Center
  • Cincinnati Children’s Hospital Medical Center
  • Weill Cornell Medical College
  • University of Florida

“This unprecedented look at the health of adults living with congenital heart disease allows us to get a full spectrum view by combining clinical data with patient-reported health data,” says Dr. Carton.

The first patient-powered registry for adults with CHD — the Congenital Heart Initiative (CHI) is a key component of this research. Launched with seed funding from Children’s National and the Heart Research Alliance at UCSF, the CHI is led by Dr. John and her team at Children’s National in addition to a broad multi-stakeholder advisory board, including patients. The CHI was co-developed with input from patients, clinicians and researchers and continues to involve these voices in the advancement of the registry. Patients who are recruited for this research will participate via enrollment in the registry, which will allow researchers to ask patients directly about health, wellness and any specific barriers to care. Learn more about CHI’s progress in their first annual report.

“Patients, like myself, are charting a new course and we desire answers to significant questions, as do our providers, about impact of lifelong specialized care, along with improved understanding of the quality-of-life patients experience,” says Leezer. “This project represents a huge step forward towards obtaining answers for the adult CHD community.”

The study also draws on the vast health data resources of PCORnet®, the National Patient-Centered Clinical Research Institute, to conduct this study more efficiently. With health records for 66 million patients available for observational studies, the PCORI-funded PCORnet provides vast scale to power research on conditions affecting even small numbers of people.

“We are confident that this research will yield critical learnings that will empower the community, align resources and spur future innovation to better meet the specialized care needs of this emerging population,” says Mark Roeder, president and chief executive officer for the Adult Congenital Heart Association.

PCORI is an independent, nonprofit organization authorized by Congress in 2010 to fund research that will provide patients, their caregivers and clinicians and other health care decision makers with the evidence-based information needed to make better-informed health care choices.

pregnant woman getting a checkup

Children’s National awarded $4.2 million to lead maternal mental health research programs

pregnant woman getting a checkup

Mothers and their babies often experience stress, depression and anxiety, which impacts the infant’s brain development.

Children’s National Hospital announces a $4.2 million funding award from the Patient-Centered Outcomes Research Institute (PCORI) to support maternal mental health research. The Developing Brain Institute at Children’s National will lead a new program that seeks to advance perinatal mental health and well-being while addressing racial disparities in access to resources that could boost positive health outcomes for women with few opportunities.

Mothers and their babies often experience stress, depression and anxiety, which impacts the infant’s brain development. Maternal psychological distress is more pronounced among low-income mothers — a health disparity that was exacerbated during the COVID-19 pandemic.

“The new fund will support many scientific research portfolios, including our project that will ensure pregnant women in D.C. get the care they need and deserve,” said Catherine Limperopoulos, Ph.D., director of The Developing Brain Institute at Children’s National and co-principal investigator of the project.

“I’m honored to be working alongside Dr. Limperopoulos and our partners. Collectively, our team aims to meet the needs of African American pregnant and postpartum women and their families during this important transition in their lives by providing services to address social determinants of health and prevent and treat maternal distress,” said Huynh-Nhu Le, Ph.D., the co-principal investigator of the project and professor in the Clinical Psychology program, part of the department of Psychological and Brain Sciences at George Washington University.

Cognitive-behavioral intervention, patient navigation and peer support, such tailored strategies developed in the program will provide effective mental health screening and care for 1,000 mothers living in Washington D.C. that is responsive to their cultural, social, environmental, behavioral and medical needs. The participants will access the resources either online or in-person, depending on the type of assistance that fits their lifestyle.

“I am overjoyed that PCORI has provided this essential funding, giving life to our project. The research done here will have a grand effect! Our goals are ambitious: To dissect all aspects of maternal health, beyond just mental health, literally creating a detailed timeline of events a mother can anticipate experiencing from pregnancy, at delivery and postpartum,” said Shanae Bond, one of the women whose firsthand experience giving birth in D.C. informed the study design. “With the maternal health crisis we are currently facing, it’s imperative to gain this type of insight to not only support mothers but to learn how they wish to be supported and how to best improve the care they receive – based on how it impacts, improves (or impairs) their lives,” said Bond.

The multidisciplinary group includes doctors, midwives, psychologists, advisors, community leaders and four prenatal care centers, MedStar Washington Hospital Center, Howard University, The George Washington University and Unity Health Care.

“Our initiative brings together obstetrics, pediatrics, and mental health care in an integrated care model. This collaboration brings early identification and immediate care coordination to its rightful place at the center of care,” said Loral Patchen, Ph.D., CNM, vice chair, Innovation and Community Programs at MedStar Washington Hospital Center. “The prenatal period offers an opportunity for us to support emotional healing, build coping strategies, and offer a safe space for people to prepare for the complex transitions that accompany childbearing. Offering services prior to delivery optimizes opportunity for strong parent-infant attachment and mitigates potential disruptions.”

Kristin L. Atkins, M.D., FACOG, assistant professor in the Obstetrics and Gynecology Department at Howard University College of Medicine, mentioned that Howard University is honored to partner with Children’s National Hospital. “The new program will help discover more about prenatal care interventions related to maternal mental health and how they may impact fetal and pediatric brain development,” said Dr. Atkins. “We are just discovering the impact of long-standing stress on health and well-being, and this starts in utero.”

To Jennifer Keller, M.D., MPH, FACOG, associate professor at The George Washington University School of Medicine & Health Sciences, this project is essential. “The events of the last year have had a profound impact on families in this city,” said Dr. Keller. “This project begins at a time of critical mental health needs for pregnant people in D.C.”

Siobhan Burke, M.D., director of OB/GYN at Unity Health Care, is also thrilled to be part of this partnership. “We all know underlying stressors such as financial difficulties, housing instability and systemic racism can impact health, but it’s important to find out what these things do to the developing fetus and to explore strategies to make lives better,” said Dr. Burke.

In 2020, Children’s National established The Clark Parent & Child Network funded by a $36 million investment from the A. James & Alice B. Clark Foundation. The Clark Network aims to provide families with greater access to mental health care and community resources. New projects like the D.C. mother-infant behavioral wellness program underwritten by PCORI funding will become natural extensions of this essential work.

“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to fill an important gap in our health knowledge and give people information to help them weigh the effectiveness of their care options,” said PCORI Executive Director Nakela L. Cook, M.D., M.P.H.. “We look forward to following the study’s progress and working with Children’s National Hospital to share the results.”

This $4.2 million PCORI funding has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

 

Dr. Lauri Tosi examines a patient

Building patient-centered outcomes research in osteogenesis imperfecta

Dr. Lauri Tosi examines a patient

Children’s orthopaedic surgeon Laura Tosi, M.D., is the co-lead on a program to improve patient-centered outcomes research and education in osteogenesis imperfecta that recently received a Eugene Washington Engagement Award of $250,000 from the Patient-Centered Outcomes and Research Institute (PCORI).

Children’s orthopaedic surgeon Laura Tosi, M.D., is the co-lead on a program to improve patient-centered outcomes research and education in osteogenesis imperfecta (OI) that recently received a Eugene Washington Engagement Award of $250,000 from the Patient-Centered Outcomes and Research Institute (PCORI). Dr. Tosi serves as project co-lead alongside colleagues Tracy Hart, project lead, from the Osteogenesis Imperfecta Foundation (OIF) and Bryce Reeve, Ph.D., co-project lead, director of the Center for Health Measurement at Duke University.

The project, which will be housed at the Osteogenesis Imperfecta Foundation, will run for two years and seeks to:

  • Create a community of stakeholders (patients/caregivers/clinicians/researchers) who are trained or training in patient-centered outcomes research, with specific attention to priority topics identified by the OI community.
  • Expand communications and education strategies related to patient-centered outcomes research to enhance the care of the OI community.
  • Establish and extend the capacity among patients, caregivers, clinicians and researchers in OI to participate in both patient-centered outcomes research and comparative effectiveness activities.
  • Develop an OI-specific toolkit focused on disseminating evidence-based clinical care recommendations to stakeholders and care providers, based on sustainable input from the OI community.
  • Extended the reach of these activities to support other rate bone disease communities.

Osteogenesis imperfecta is a group of genetic disorders causing connective tissue dysfunction and bone fragility. It is the most common of nearly 450 rare skeletal disorders and affects an estimated 25,000 to 50,000 people in the U.S. Collecting the patient’s perspective about natural history, clinical best practices, quality of life and research priorities is challenging because, like so many rare diseases, the affected population is relatively small and  geographically dispersed.

“We hope this project will give us the ability to develop a set of best practices for care and research based on research that incorporates the patient’s point-of-view,” says Dr. Tosi. “I’m excited to work with this team and begin to change how we think about and care for OI patients and their families.”