Research recruitment through the patient portal: perspectives of community focus groups in Seattle and Atlanta.

Objective: Research recruitment through patient portals (ie, patient-facing, web-based clinical interfaces) has the potential to be effective, efficient, and inclusive, but best practices remain undefined. We sought to better understand how patients view this recruitment approach. Materials and Methods: We conducted 6 focus groups in Atlanta, GA and Seattle, WA with members of patient advisory committees and the general public. Discussions addressed acceptability of patient portal recruitment and communication preferences. Focus groups were audio-recorded, transcribed, and analyzed using deductive and inductive codes. Iterative team discussions identified major themes. Results: Of 49 total participants, 20 were patient advisory committee members. Participants' mean age was 49 (range 18-74); 59% identified as non-Hispanic White and 31% as Black/African American. Participants were supportive of patient portal recruitment and confident that messages were private and legitimate. Participants identified transparency and patient control over whether and how to participate as essential features. Concerns included the frequency of research messages and the ability to distinguish between research and clinical messages. Participants also discussed how patient portal recruitment might affect diversity and inclusion. Discussion: Focus group participants generally found patient portal recruitment acceptable and perceived it as secure and trustworthy. Transparency, control, and attention to inclusiveness were identified as key considerations for developing best practices. Conclusion: For institutions implementing patient portal recruitment programs, continued engagement with patient populations can help facilitate translation of these findings into best practices and ensure that implemented strategies accomplish intended goals.

Experimenting with modifications to consent forms in comparative effectiveness research: understanding the impact of language about financial implications and key information.

BACKGROUND: Informed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with participating may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown. METHODS: Two online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial. RESULTS: Likelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002). CONCLUSIONS: These findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment.

Reframing Recruitment: Evaluating Framing in Authorization for Research Contact Programs.

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.

Public attitudes toward an authorization for contact program for clinical research.

We conducted an online experimental survey to evaluate attitudes toward an authorization for contact (AFC) program allowing researchers to contact patients about studies based on electronic record review. A total of 1070 participants were randomly assigned to 1 of 3 flyers varying in design and framing. Participants were asked to select concerns about and reasons for signing up for AFC. Logistic regression and latent class analysis were conducted. The most commonly selected concerns included needing more information (43%), privacy (40%), and needing more time to think (28%). A minority were not interested in participating in research (16%) and did not want to be bothered (15%). Latent class analysis identified clusters with specific concerns about privacy, lack of interest in research, and not wanting to be bothered. A novel flyer with simple and positive framing was associated with lower odds of both not wanting to be bothered (P = .01) and not being interested in research (P = .01). Many concerns about AFC programs appear nonspecific. Addressing privacy, lack of interest in research, and not wanting to be bothered warrant further study as ways to enhance recruitment.

High-Yield Birth-Cohort Hepatitis C Virus Screening and Linkage to Care Among Underserved African Americans, Atlanta, Georgia, 2012-2013.

OBJECTIVE: Hepatitis C virus (HCV) infection disproportionately affects certain populations, including those born between 1945 and 1965 (i.e., baby boomers) and African Americans. As part of the Hepatitis Testing and Linkage to Care initiative, which promoted hepatitis B and hepatitis C screening, posttest counseling, and linkage to care at 34 U.S. sites, we conducted routine HCV screening to identify previously undiagnosed, primarily African American baby boomers with chronic hepatitis C infection and link them to care. METHODS: We launched the Internal Medicine Trainees Identifying and Linking to Treatment for Hepatitis C (TILT-C) initiative at the Grady Memorial Hospital Primary Care Center and Grady Liver Clinic in Atlanta, Georgia, in October 2012, and present results from the first year. TILT-C faculty implemented an electronic medical record prompt and conducted educational sessions to boost HCV screening. A project coordinator tracked testing outcomes and linked HCV-positive patients to care. RESULTS: Of 2,894 patients tested for anti-HCV, 201 (6.9%) tested positive. Men had a significantly higher (p<0.001) prevalence of HCV infection than women, with 106 of 1,091 (9.7%) men compared with 95 of 1,803 (5.3%) women testing anti-HCV positive. A total of 174 of 201 (86.6%) anti-HCV-positive patients received HCV ribonucleic acid (RNA) testing. Of 124 patients with a positive HCV RNA test, 122 were referred to care and 120 attended the first appointment. CONCLUSION: The TILT-C screening program was feasible and effective in detecting previously undiagnosed HCV infection and linking patients to care. The unexpectedly high prevalence of HCV infection in this primarily African American, baby boomer population underscores the need for aggressive HCV screening efforts in similar populations.