Reframing Recruitment: Evaluating Framing in Authorization for Research Contact Programs

Abstract

Background

The changing clinical research recruitment landscape involves practical challenges but introduces opportunities. Researchers can now identify large numbers of eligible patients through electronic health record review and can directly contact those who have authorized contact. Applying behavioral science-driven strategies to design and frame communication could affect patients’ willingness to authorize contact and their understanding of these programs. The ethical and practical implications of various strategies warrant empirical evaluation.

Methods

We conducted an online survey (n = 1070) using a nationally-representative sample. Participants were asked to imagine being asked for authorization for research contact in clinic. They were randomly assigned to view one of three flyers: #1-neutral text flyer; #2-a positive text flyer; or #3-positive graphics-based flyer. Primary outcomes included likelihood of enrollment and comprehension of the program. Chi-Square tests and regression analyses were used to examine whether those who saw the positive flyers were more likely to enroll and had increased comprehension.

Results

Compared to the neutral flyer, individuals who received the positive text flyer were numerically more likely to enroll, but this was not statistically significant (24.2% v. 19.0%, p = 0.11). Individuals who received the positive graphics flyer were more likely to enroll (28.7% v. 19.0%, p = 0.002). After adjustment, individuals assigned to both novel flyers had increased odds of being likely to enroll (OR = 1.55 95%CI [1.04, 2.31] and OR = 1.95 95%CI [1.31, 2.91]). Flyer type did not affect overall comprehension (p = 0.21), and greater likelihood of enrollment was observed only in individuals with better comprehension.

Conclusions

This study demonstrated that employing behavioral science-driven communication strategies for authorization for research contact had an effect on likelihood of hypothetical enrollment but did not significantly affect comprehension. Strategies using simple, positive language and visual tools may be effective and ethically appropriate. Further studies should explore how these and other approaches can help to optimize research recruitment.

Keywords:

• Informed consent
• clinical research
• recruitment
• electronic health records
• research ethics
• survey

Acknowledgements

The authors would like to thank Holly Taylor for her assistance with project development.

Author contributions

CDS, CG, Y-AK, SAK, ARM, NKN, BGP, KMP, SKS, JS, BSW, and NWD contributed to the design, interpretation, drafting, and critical revision of the work, as well as the final approval of the version to be published. Data collection and analysis were completed by CDS, Y-AK, NKN, and NWD. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Disclosure statement

Dr. Sugarman is a member of Merck KGaA’s Bioethics Advisory Panel and Stem Cell Research Oversight Committee; IQVIA’s Ethics Advisory Panel; Aspen Neurosciences’ Scientific Advisory Board; and has consulted with Portola Pharmaceutical’s, Inc. Dr. Dickert reports research funding from NCATS. No other authors report any significant financial conflicts of interest.

Ethical approval

The study protocol was approved by the Emory University Institutional Review Board.

Additional information

Funding

This work was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Grant [UL1TR002378] and [UL1 TR002319]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.