An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine

Elizabeth H Golembiewski; Arch G Mainous 3rd; Kiarash P Rahmanian; Babette Brumback; Benjamin J Rooks; Janice L Krieger; Kenneth W Goodman; Ray E Moseley; Christopher A Harle

doi:10.1370/afm.2610

An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine

Ann Fam Med. 2021 Jan-Feb;19(1):16-23. doi: 10.1370/afm.2610.

Authors

Elizabeth H Golembiewski¹, Arch G Mainous 3rd^{2

3}, Kiarash P Rahmanian³, Babette Brumback⁴, Benjamin J Rooks³, Janice L Krieger⁵, Kenneth W Goodman⁶, Ray E Moseley³, Christopher A Harle⁷

Affiliations

¹ Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota golembiewski.elizabeth@mayo.edu.
² Department of Health Services Research, Management and Policy, University of Florida, Gainesville, Florida.
³ Department of Community Health and Family Medicine, University of Florida, Gainesville, Florida.
⁴ Department of Biostatistics, University of Florida, Gainesville, Florida.
⁵ Department of Advertising, University of Florida, Gainesville, Florida.
⁶ Institute for Bioethics and Health Policy, Miller School of Medicine, University of Miami, Miami, Florida.
⁷ Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida.

Abstract

Purpose: Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research.

Methods: A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months.

Results: A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09; P <.001) and subjective understanding (B = 18.04; SE = 2.58; P <.001). At 6-month follow-up, compared with the interactive e-consent, participants who used the trust-enhanced e-consent reported greater satisfaction (B = 0.9; SE = 1.0; P <.001) and subjective understanding (B = 32.2; SE = 2.6, P <.001).

Conclusions: Patients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.

Keywords: consumer health informatics; electronic health records; health communication; informed consent; trust.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural

MeSH terms

Adult
Aged
Consumer Health Informatics*
Electronic Health Records
Electronics
Family Practice / organization & administration*
Female
Health Communication
Humans
Informed Consent*
Male
Middle Aged
Patient-Centered Care*
Telemedicine
Trust*

Grants and funding

R01 HD086700/HD/NICHD NIH HHS/United States