health disparities

Grand Rounds January 17, 2025: Design for Diversity: Designing Studies for Representativeness and Generalizability (Christopher J. Lindsell, PhD)

Posted on by Sophia Ramirez

Speaker

Christopher J. Lindsell, PhD
Professor and co-Chief, Biostatistics, Duke University
Director, Data Science and Biostatistics, DCRI
Director, Biostatistics and Bioinformatics, CTSI
Editor in Chief, Journal of Clinical and Translational Science

Keywords

Study Design; Diversity; Health Disparities; Evidence Generation

Key Points

  • Health disparities are factors that contribute to preventable differences in health status and outcomes. They can be environmental, sociocultural, behavioral, and biological. These are preventable differences with adverse effects for populations.
  • When research teams don’t consider factors that change outcomes for certain populations but not others, research can contribute to a difference in health status and outcomes. A flawed evidence generation system compounds the problem.
  • One popular solution is to measure and adjust for diversity variables; however, research teams often get the variable wrong or use it incorrectly.
  • By designing for diversity, research teams can begin to address the generalizability of evidence; develop an understanding of factors that contribute to success or failure of interventions among diverse populations; and remove the evidence generation system as a contributor to health disparities.
  • Designing for diversity is an optimization problem. Historically, study designs have been optimized for the researcher; Dr. Lindsell proposed that researchers optimize for the participant.
  • Research that is optimized for the participant is rigorous and flexible; safe and practical; and complete and simple. Participants should be embedded in every part of the research process. This can be difficult – there are tradeoffs involved – but it is effective.
  • The interface between data generation and data use is crucial. Making systems that work to bring in the right information and systems that use that information appropriately are two pieces of the same puzzle.
  • Dr. Lindsell included a call to ditch the ordinary subgroup analysis, noting that groups are not binary and not all groups have meaning. He suggested a focus on interaction terms.

Discussion Themes

Institutions should be supporting research teams in their ability to achieve diversity; this should be a matter of course, rather than something to be achieved without support and then celebrated as a remarkable accomplishment.

Looking forward, as data infrastructure becomes increasingly robust, research teams and communities may be able to collaborate to build a more complete understanding of individuals’ health states and who may be in need of an intervention.

Grand Rounds December 13, 2024: Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial (Gbenga Ogedegbe, MD, MPH, FACP)

Posted on by Sophia Ramirez

Speaker

Gbenga Ogedegbe, MD, MPH, FACP
Dr. Adolph & Margaret Berger Professor of Population Health
NYU Grossman School of Medicine
Director, Institute for Excellence in Health Equity (IEHE)
NYU Langone Health

Keywords

Hypertension; Racial Disparities; Case Management; Telemonitoring

Key Points

  • There are significant racial disparities when it comes to stroke outcomes in the U.S., with Black and Hispanic populations experiencing poorer outcomes than Caucasian populations. A major predictor for these disparities is hypertension (HTN); controlling HTN is key to secondary stroke prevention.
  • Home Blood Pressure Telemonitoring (HBPTM) and Nurse Case Management (NCM) have proven efficacy in addressing multilevel barriers to HTN control. However, their effectiveness remains untested in stroke patients, and their implementation is sub-optimal in Black and Hispanic patients.
  • The research team looked at the comparative effectiveness of HBPTM alone versus HBPTM plus telephone-based NCM when administered to Black and Hispanic stroke survivors with uncontrolled hypertension. They measured within-patient change in systolic blood pressure (SBP) from baseline to 12 months and the rate of recurrent stroke at 24 months.
  • This was a multisite, practice-based, comparative effectiveness randomized clinical trial conducted at six public hospitals and three academic medical centers in New York City. About 225 patients were randomized to each of the two arms.
  • The study population was defined by low-income, minoritized communities with significant comorbidity. This is a departure from much of the existing literature, Dr. Ogedegbe noted, in which patient populations tend to be more insured, more highly educated, and have higher employment rates.
  • The research team found that both groups experienced significant SBP reduction at both the six-month and 12-month mark. The telehealth intervention that combined HBPTM with NCM led to greater SBP reduction than HBPTM alone. There was no significant difference in the rate of recurrent stroke between the two groups across a 24-month period.
  • These findings provide strong empirical evidence for widespread implementation in low-income stroke survivors with multiple comorbidities. Policymakers can use this evidence to implement these strategies in minority patients with stroke and uncontrolled hypertension.
  • Implementation challenges will include coverage of HBPM, which varies among private payers and Medicaid programs; clinical support services for use; access to the internet, to transmit data for virtual care; and integration of data into electronic medical records.

Discussion Themes

To effectively address inequities in hypertension, researchers must partner with policymakers, payers, and community-based organizations ahead of time, with a focus on team-based care.

Sustainment can be an Achilles Heel for embedded trials, as programs that have been shown to be successful aren’t always covered by insurance. Chronic disease management with team-based care is a good step that practices can invest in in the interim.

The fidelity to the NCM intervention, measured by the participation in 20 NCM calls and the compliance with HBPTM, was around 68% – a decent figure given the challenges of conducting a trial in a real-world setting, Dr. Ogedegbe noted.

Front-line doctors were instrumental in helping the research teams onboard the sites and think through recruitment.

May 22, 2023: EMBED Finds Racial and Ethnic Differences in Buprenorphine Initiation for Opioid Use Disorder

Posted on by Damon Seils

EMBED logoIn a secondary analysis from the EMBED pragmatic clinical trial, Black patients with opioid use disorder were less likely than White patients to be initiated on buprenorphine in the emergency department.

The study’s findings were published recently in Academic Emergency Medicine.

EMBED, an NIH Collaboratory Trial, was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States. The trial evaluated a clinical decision support system for initiating buprenorphine in emergency department settings.

The racial disparity in buprenorphine initiation remained after adjustment for patient, clinician, and site characteristics. Even in emergency departments in academic hospitals, where rates of buprenorphine were higher overall, Black patients received proportionally less buprenorphine initiations than White patients. Hispanic patients were more likely to receive buprenorphine than non-Hispanic patients in both community and academic emergency departments. However, adjustment for discharge diagnosis attenuated the association between ethnicity and buprenorphine initiation.

“Attention should be focused on identifying continued disparities in [emergency department] treatment of opioid use disorder by race and ethnicity,” the authors concluded, “as well as the barriers and inequities that continue to limit patients’ ability to access the [emergency department] for treatment of opioid use disorder.”

EMBED was supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and received logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about EMBED in the Living Textbook, and learn about the other NIH Collaboratory Trials.

Read the full report.

March 17, 2022: NIH Will Fund New NIH Collaboratory Trials That Address Health Disparities

Posted on by Damon Seils

Promotional banner for funding opportunity announcementThe NIH released a request for applications (RFA) for new NIH Pragmatic Trials Collaboratory Trial grants that address health disparities. NIH program and review staff will discuss the funding opportunity in an upcoming webinar. Registration for the webinar is required.

The RFA for this funding opportunity encourages applications that focus on improving health outcomes in populations that experience health disparities, such as higher rates of disease or mortality compared with the general population. Applications are due June 17, 2022. Letters of intent are due 30 days prior (May 17, 2022).

For the purposes of this funding opportunity, the NIH-designated U.S. health disparity populations definition includes: Blacks/African Americans, Hispanics/ Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. 

Similar to the NIH Pragmatic Trials Collaboratory’s other NIH Collaboratory Trials, the new projects will have a planning and implementation phase and will be large-scale pragmatic or implementation trials that are embedded in healthcare delivery systems. The overarching goal of the projects is to improve care delivery and health outcomes across the lifespan.

Read our Living Textbook chapter about how to develop a compelling grant application for a pragmatic clinical trial.

October 25, 2021: NIH HEAL Initiative Issues RFA for Projects that Advance Health Equity in Pain Management

Posted on by terren.green@duke.edu

The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM recently announced a funding opportunity for new studies that aim to develop, test, and implement interventions that mitigate bias, discrimination, socioeconomic, or environmental barriers to quality pain assessment, treatment, and management for populations that experience health disparities (HDPs) in the United States.

For the purposes of this funding opportunity, the NIH-designated U.S. health disparity populations definition includes: Blacks/African Americans, Hispanics/ Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.

The NIH HEAL Initiative supports research to improve treatment for opioid misuse and addiction and enhance pain management. This RFA calls for applications that “demonstrate an existing health disparity or health disparities in acute and/or chronic pain in the population of interest and outline a detailed plan for an evidence-based intervention to mitigate or eliminate the disparity(disparities) to improve pain and pain-related outcomes.”

Applications are due by 5pm on December 9, 2021.  Letters of intent are due 30 days prior (November 9, 2021).

This award will support a 1 to 2-year, milestone-driven planning phase (R61) with the possibility of an additional 4-year implementation phase (R33).

Read the full request for applications.

The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit: https://heal.nih.gov.

October 19, 2021: NIH Issues RFA for New NIH Collaboratory Trials That Address Health Disparities

Posted on by Karen Staman

NIH logoThe NIH recently released a request for applications (RFA) for new NIH Collaboratory Trial grants. The RFA encourages applications that focus on improving health outcomes in populations that experience health disparities, such as higher rates of disease or mortality compared with the general population. These populations may be defined by race, ethnicity, geography, or socioeconomic status.

Applications are due December 15, 2021. Letters of intent are due 30 days prior (November 15, 2021).

For the purposes of this funding opportunity, the NIH-designated U.S. health disparity populations definition includes: Blacks/African Americans, Hispanics/ Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. 

Similar to the NIH Collaboratory’s other NIH Collaboratory Trials, the new projects will have a planning and implementation phase and will be large-scale pragmatic or implementation trials that are embedded in healthcare delivery systems. The overarching goal of the projects is to improve care delivery and health outcomes in Americans across the lifespan.

Read the full request for applications.

Read our Living Textbook chapter about how to develop a compelling grant application for a pragmatic clinical trial.