Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials

Haussen, Diogo C; Doppelheuer, Shannon; Schindler, Kiva M; Grossberg, Jonathan A; Bouslama, Mehdi; Schultz, Meagan; Perez, Hilarie; Hall, Alex; Frankel, Michael; Nogueira, Raul G

doi:10.1161/strokeaha.117.018380

Cited by 29 publications

(46 citation statements)

References 4 publications

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“…The e-Consent was then sent to the LAR’s smartphone for review. The e-Consent design has been previously published 4. In summary, we used REDCap (Research Electronic Data Capture), a secure Health Insurance Portability and Accountability Act-compliant web-based platform designed for research data capture.…”

Section: Methodsmentioning

confidence: 99%

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Legal authorized representative experience with smartphone-based electronic informed consent in an acute stroke trial

Haussen

Craft

Doppelheuer

et al. 2019

J NeuroIntervent Surg

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BackgroundThe pilot use of a smartphone platform for electronic informed consent (e-Consent) in large vessel occlusion acute stroke (LVOS) trials has recently been reported. The degree of satisfaction from Legal Authorized Representatives (LARs) with regard to this process remains to be established.MethodsA single-center study evaluating the experience of LARs with the use of e-Consent in a LVOS randomized trial of an investigational drug administered within 12 hours of last known normal was carried out. A structured survey was used to evaluate the experience of the LARs with the e-consenting process.ResultsFrom February to November 2018, 60 consecutive patients were e-Consented. Of these, 53 LARs completed the survey. The median (IQR) age of the patients was 63 (53–70) years, baseline/discharge National Institutes of Health Stroke Scale score was 17 (12–20)/3(1–12), and 45% were independent at discharge. The survey was applied in person in 43% of cases and via telephone in 57%. Median LAR age was 48 (39–59) years, 64% were female, and a multi-ethnic composition was observed. Forty percent of LARs had less than tertiary level of education (high-school or less). Regarding the e-Consent, 98% of LARs reported to be ‘clear’ and 83% felt ‘very comfortable’ in signing. The overall experience was ‘excellent/good’ in 91%. Despite the positive general impression regarding the use of e-Consent, 12 LARs (22%) would have preferred paper consent. Multivariable regression indicated that lower educational status (tertiary education or less: OR 5.09, 95% CI 1.02 to 25.48; p=0.04) and lower baseline ASPECTS score (OR 0.63, 95% CI 0.41 to 0.96; p=0.03) were independently associated with preference for paper consent.Conclusionse-Consent was overall very well perceived by LARs in a randomized clinical trial of LVOS. A minority of proxies, who were more commonly less formally educated, would have preferred paper consenting.

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Section: Methodsmentioning

confidence: 99%

“…We have recently reported the pilot use of a smartphone platform for electronic informed consenting (e-Consent) in acute stroke trials 4. The e-Consent was found to streamline the consenting process in a RCT involving patients with emergent large vessel occlusion strokes (LVOS).…”

Section: Introductionmentioning

confidence: 99%

Legal authorized representative experience with smartphone-based electronic informed consent in an acute stroke trial

Haussen

Craft

Doppelheuer

et al. 2019

J NeuroIntervent Surg

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“…Current evidence suggests that telemedicine, which can include video conferencing, web-based materials, and other media, under certain circumstances, can provide care equal to that of in-person interactions, with potentially lower cost [30,31]. Additionally, early adopters of remote consent via multimedia platforms have found that utilization of such platforms can streamline the consent process, are appealing to prospective participants as users are more likely to opt for the remote option of consent (if available), and users have demonstrated equal satisfaction with in person vs remote consent options [32,33]. Toward this end, some STRIDE exemplar studies utilized eConsent with a remote consenting component.…”

Section: Remote Consenting and Telemedicinementioning

confidence: 99%

A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent

Lawrence

Dunkel

McEver

et al. 2020

J. Clin. Trans. Sci.

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Introduction: The updated common rule, for human subjects research, requires that consents “begin with a ‘concise and focused’ presentation of the key information that will most likely help someone make a decision about whether to participate in a study” (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613–615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377–381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant’s race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2018; 47(4): 529–534.). Methods: We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information. Results: The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers. Conclusions: Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process.

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“…The wet signature is a feature in REDCap which allows participants to sign consent forms online in real time, by signing their name with their finger or computer mouse on a document as if the participant is using a pen and paper. 41 This process does not require an additional confirmation procedure 42 and is customary in REDCap consenting and data collection. 41 The informed consent document specifies the posting of clinical trial information at Clinical-Trials.…”

Section: Recruitment and Consentmentioning

confidence: 99%

“…41 This process does not require an additional confirmation procedure 42 and is customary in REDCap consenting and data collection. 41 The informed consent document specifies the posting of clinical trial information at Clinical-Trials. gov.…”

Section: Recruitment and Consentmentioning

confidence: 99%

Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial

et al. 2020

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IntroductionMen who are overweight or obese in the rural Midwestern USA are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care and poor lifestyle behaviours that contribute to sedentary lifestyle and unhealthy diet. Self-monitoring of eating and activity has demonstrated efficacy for weight loss. Use of mobile technologies for self-monitoring eating and activity may address rural men’s access disparities to preventive health resources and support weight loss. Our pilot trial will assess the feasibility and acceptability of two mobile applications for weight loss in rural men to inform a future, full-scale trial.Methods and analysisA 6-month randomised controlled trial with contextual evaluation will randomise 80 men using a 1:1 ratio to either a Mobile Technology Plus (MT+) intervention or a basic Mobile Technology (MT) intervention in rural, midlife men (aged 40–69 years). The MT+ intervention consists of a smartphone self-monitoring application enhanced with discussion group (Lose-It premium), short message service text-based support and Wi-Fi scale. The MT group will receive only a self-monitoring application (Lose-It basic). Feasibility and acceptability will be evaluated using number of men recruited and retained, and evaluative focus group feedback. We seek to determine point estimates and variability of outcome measures of weight loss (kg and % body weight) and improved dietary and physical activity behaviours (Behavioral Risk Factor Surveillance System (BRFSS) physical activity and fruit and vegetable consumption surveys, data from Lose-It! application (kcal/day, steps/day)). Community capacity will be assessed using standard best practice methods. Descriptive content analysis will evaluate intervention acceptability and contextual sensitivity.Ethics and disseminationThis protocol was approved by the University of Nebraska Medical Center Institutional Review Board (IRB# 594–17-EP). Dissemination of findings will occur through ClinicalTrials.gov and publish pilot data to inform the design of a larger clinical trial.Trial registration numberNCT03329079; preresults. Protocol V.10, study completion date 31 August 2020. Roles and responsibilities funder: NIH/NINR Health Disparities Section 1R15NR017522-01.

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Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials

Abstract: e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes.

Cited by 29 publications

References 4 publications

Legal authorized representative experience with smartphone-based electronic informed consent in an acute stroke trial

Legal authorized representative experience with smartphone-based electronic informed consent in an acute stroke trial

A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent

Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial

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