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Randomized Controlled Trial
. 2021 Jan-Feb;19(1):16-23.
doi: 10.1370/afm.2610.

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

Elizabeth H Golembiewski  1 , Arch G Mainous 3rd  2   3 , Kiarash P Rahmanian  3 , Babette Brumback  4 , Benjamin J Rooks  3 , Janice L Krieger  5 , Kenneth W Goodman  6 , Ray E Moseley  3 , Christopher A Harle  7
Affiliations
Randomized Controlled Trial

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

Elizabeth H Golembiewski et al. Ann Fam Med. 2021 Jan-Feb.

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.

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Figures

Figure 1.
Figure 1.
CONSORT flow diagram of participant randomization, allocation, follow-up, and analysis. CONSORT = Consolidated Standards of Reporting Trials
Figure 2A.
Figure 2A.
Primary outcomes: satisfaction with decision and subjective understanding.
Figure 2A.
Figure 2A.
Primary outcomes: satisfaction with decision and subjective understanding.
Figure 2B.
Figure 2B.
Secondary outcomes: objective knowledge, perceived voluntariness, and trust in medical researchers. Notes: Values for all outcomes represent means by e-consent study arm by follow-up assessment time point based on descriptive analyses of study data. Numbers of participants for all outcomes were 734 at immediate follow-up, 624 at 1-week follow-up, and 510 at 6-month follow-up. Numbers of participants for at each follow-up by e-consent group are shown in Figure 1.
Figure 2B.
Figure 2B.
Secondary outcomes: objective knowledge, perceived voluntariness, and trust in medical researchers. Notes: Values for all outcomes represent means by e-consent study arm by follow-up assessment time point based on descriptive analyses of study data. Numbers of participants for all outcomes were 734 at immediate follow-up, 624 at 1-week follow-up, and 510 at 6-month follow-up. Numbers of participants for at each follow-up by e-consent group are shown in Figure 1.
Figure 2B.
Figure 2B.
Secondary outcomes: objective knowledge, perceived voluntariness, and trust in medical researchers. Notes: Values for all outcomes represent means by e-consent study arm by follow-up assessment time point based on descriptive analyses of study data. Numbers of participants for all outcomes were 734 at immediate follow-up, 624 at 1-week follow-up, and 510 at 6-month follow-up. Numbers of participants for at each follow-up by e-consent group are shown in Figure 1.
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