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Research ArticleOriginal Research

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

Elizabeth H. Golembiewski, Arch G. Mainous, Kiarash P. Rahmanian, Babette Brumback, Benjamin J. Rooks, Janice L. Krieger, Kenneth W. Goodman, Ray E. Moseley and Christopher A. Harle
The Annals of Family Medicine January 2021, 19 (1) 16-23; DOI: https://doi.org/10.1370/afm.2610
Elizabeth H. Golembiewski
1Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota
PhD, MPH
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  • For correspondence: golembiewski.elizabeth@mayo.edu
Arch G. Mainous III
2Department of Health Services Research, Management and Policy, University of Florida, Gainesville, Florida
3Department of Community Health and Family Medicine, University of Florida, Gainesville, Florida
PhD
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Kiarash P. Rahmanian
3Department of Community Health and Family Medicine, University of Florida, Gainesville, Florida
MPH
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Babette Brumback
4Department of Biostatistics, University of Florida, Gainesville, Florida
PhD
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Benjamin J. Rooks
3Department of Community Health and Family Medicine, University of Florida, Gainesville, Florida
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Janice L. Krieger
5Department of Advertising, University of Florida, Gainesville, Florida
PhD
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Kenneth W. Goodman
6Institute for Bioethics and Health Policy, Miller School of Medicine, University of Miami, Miami, Florida
PhD
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Ray E. Moseley
3Department of Community Health and Family Medicine, University of Florida, Gainesville, Florida
PhD
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Christopher A. Harle
7Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida
PhD
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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.

Key words
  • consumer health informatics
  • electronic health records
  • informed consent
  • health communication
  • trust
  • Received for publication January 20, 2020.
  • Revision received April 27, 2020.
  • Accepted for publication June 3, 2020.
  • © 2021 Annals of Family Medicine, Inc.
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The Annals of Family Medicine: 19 (1)
The Annals of Family Medicine: 19 (1)
Vol. 19, Issue 1
January/February 2021
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An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine
Elizabeth H. Golembiewski, Arch G. Mainous, Kiarash P. Rahmanian, Babette Brumback, Benjamin J. Rooks, Janice L. Krieger, Kenneth W. Goodman, Ray E. Moseley, Christopher A. Harle
The Annals of Family Medicine Jan 2021, 19 (1) 16-23; DOI: 10.1370/afm.2610

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An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine
Elizabeth H. Golembiewski, Arch G. Mainous, Kiarash P. Rahmanian, Babette Brumback, Benjamin J. Rooks, Janice L. Krieger, Kenneth W. Goodman, Ray E. Moseley, Christopher A. Harle
The Annals of Family Medicine Jan 2021, 19 (1) 16-23; DOI: 10.1370/afm.2610
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