June 25, 2021: Inclusion of Diverse Participants in Pragmatic Clinical Trials: Meeting Participants Where They Are – Outreach, Trust, and Consent to Maximize Diversity (Emily O’Brien, PhD; Jonathan Jackson, PhD; Judith Schlaeger, PhD; Stacy Sterling, DrPH)

Posted on by Gina Uhlenbrauck

Speakers

Panelists:

NIA IMPACT Collaboratory
Jonathan Jackson, PhD
Executive Director
Community Access, Recruitment, and Engagement (CARE) Research Center
Massachusetts General Hospital and Harvard Medical School

GRACE
Judith Schlaeger, PhD, CNM, LAc, FAAN
Associate Professor, Department of Human Development Nursing Science
University of Illinois Chicago

GGC4H
Stacy Sterling, DrPH, MSW, MPH
Research Scientist
Kaiser Permanente Division of Research, Northern California

Guest Moderator:

Emily O’Brien, PhD
Associate Professor, Department of Population Health Sciences
Duke Clinical Research Institute
Duke University School of Medicine

Topic

Inclusion of Diverse Participants in Pragmatic Clinical Trials: Meeting Participants Where They Are – Outreach, Trust, and Consent to Maximize Diversity

Keywords

Participant diversity; Health equity; Outreach strategies; GRACE; Guiding Good Choices for Health (GGC4H); NIA IMPACT Collaboratory; Implementation science

Key Points

  • Health equity is a matter of scientific integrity. Health equity must be front and center when trials are designed and implemented because, without it, access may be undermined and effectiveness could be misrepresented.
  • Study enrollment bias occurs at every level of selection, beyond the participant level. “Healthy worker bias” can occur at the level of the healthcare system too.
  • Health equity is a crucial and unique aspect of embedded PCTs (ePCTs). While the PRECIS-2 (Pragmatic-Explanatory Continuum Indicator Summary) domains show how pragmatic a trial design is, the tool does not identify biases in the design. For research that is truly effective and generalizable, it is vital to implement PRECIS-2 through an equity lens.
  • Among the many practices that can maximize diversity in trial enrollment:
    • Tailored, personalized outreach and community connections
    • Bilingual, bicultural staff
    • Balancing fidelity with feasibility and relatability
    • Cultural and linguistic adaptation
    • Flexible scheduling
  • Incorporating a community-based participatory research model in the design of the study can assist in addressing barriers and build trust.

Discussion Themes

Concerns about racism and bias can affect the emotions and behaviors of study participants. Can these topics be incorporated into the curriculum?

What role do broad stakeholder organizations, such as funders and insurance providers, have in advancing outreach and building trust?

Implementation science offers ways to think about the complex aspects of an intervention that may not be captured in the protocol.

Read more about the GRACE and GGC4H NIH Collaboratory Trials, and visit the NIA IMPACT Collaboratory.

Tags

#pctGR, @Collaboratory1