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A Clinical Research Interaction Scale for Racial and Ethnic Minority Participants
Jennifer Y Kim1,2, Emily Botto1,2, Ruby Madison Ford1,2
1Tufts School of Medicine, Boston, Massachusetts.
JAMA Network Open
|May 13, 2025
Summary
Low-quality patient-staff interactions in clinical trials decrease trust and willingness to re-enroll among racial and ethnic minority patients. The new Clinical Research Interaction Scale can help improve their trial experience and future participation.
Area of Science:
- Clinical research
- Health equity
- Patient experience
Background:
- Racial and ethnic minorities are underrepresented in clinical trials.
- Patient-staff interactions significantly impact enrollment decisions.
- A validated scale is needed to measure these interactions.
Purpose of the Study:
- To develop and validate the Clinical Research Interaction Scale (CRIS).
- To assess the scale's ability to measure interactions affecting trust and willingness to re-enroll.
Main Methods:
- Mixed-methods study using interviews and online surveys (April 2023-June 2024).
- Scale validation involved exploratory and confirmatory factor analysis.
- Structural equation modeling assessed scale validity and relationships between interactions, trust, and re-enrollment.
Main Results:
- The 22-item CRIS demonstrated high reliability (α=0.96) and validity.
- Low-quality interactions were linked to decreased trust (β=-0.56) and willingness to re-enroll (β=0.80).
- Total sample size was 1113 participants across three cohorts.
Conclusions:
- Poor patient-staff interactions reduce trust and future participation among minority patients.
- The CRIS is a valuable tool for improving minority patient experiences and enrollment in clinical trials.
- Addressing interaction quality is crucial for advancing health equity in research.
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