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

Research output: Contribution to journalArticlepeer-review

Abstract

PURPOSE Patients are frequently asked to share their personal health informa-tion. 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 fol-low-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.

Original languageEnglish (US)
Pages (from-to)16-23
Number of pages8
JournalAnnals of family medicine
Volume19
Issue number1
DOIs
StatePublished - 2021

Keywords

  • Consumer health informatics
  • Electronic health records
  • Health communication
  • Informed consent
  • Trust

ASJC Scopus subject areas

  • Family Practice

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