Dataset Information

Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial.

ABSTRACT: Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study was to determine whether patient comprehension of telemedicine-enabled research informed consent is noninferior to standard face-to-face (F2F) research informed consent.A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic emergency department (ED) to test whether telemedicine-enabled research informed consent provided noninferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of 0.12% oral chlorhexidine gluconate in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard F2F consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc.) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified quality of informed consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes.A total of 131 patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to F2F consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p = 0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar.Telemedicine is noninferior to F2F consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials.

SUBMITTER: Bobb MR

PROVIDER: S-EPMC4938779 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial.

Bobb Morgan R MR Van Heukelom Paul G PG Faine Brett A BA Ahmed Azeemuddin A Messerly Jeffrey T JT Bell Gregory G Harland Karisa K KK Simon Christian C Mohr Nicholas M NM

Academic emergency medicine : official journal of the Society for Academic Emergency Medicine 20160618 7

<h4>Objective</h4>Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study was to determine whether patient comprehension of telemedicine-enabled research informed consent is noninferior to standard face-to-face (F2F) research informed consent.<h4>Methods</h4>A prospective, open-label randomized controlled trial was performed in a 6 ...[more]

PMID: 26990899

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Project description:BackgroundTelemedicine consultations using real-time videoconferencing has the potential to improve access and quality of care, avoid patient travels, and reduce health care costs.ObjectiveThe aim of this study was to examine the cost-effectiveness of an orthopedic videoconferencing service between the University Hospital of North Norway and a regional medical center in a remote community located 148 km away.MethodsAn economic evaluation based on a randomized controlled trial of 389 patients (559 consultations) referred to the hospital for an orthopedic outpatient consultation was conducted. The intervention group (199 patients) was randomized to receive video-assisted remote orthopedic consultations (302 consultations), while the control group (190 patients) received standard care in outpatient consultation at the hospital (257 consultations). A societal perspective was adopted for calculating costs. Health outcomes were measured as quality-adjusted life years (QALYs) gained. Resource use and health outcomes were collected alongside the trial at baseline and at 12 months follow-up using questionnaires, patient charts, and consultation records. These were valued using externally collected data on unit costs and QALY weights. An extended sensitivity analysis was conducted to address the robustness of the results.ResultsThis study showed that using videoconferencing for orthopedic consultations in the remote clinic costs less than standard outpatient consultations at the specialist hospital, as long as the total number of patient consultations exceeds 151 per year. For a total workload of 300 consultations per year, the annual cost savings amounted to €18,616. If costs were calculated from a health sector perspective, rather than a societal perspective, the number of consultations needed to break even was 183.ConclusionsThis study showed that providing video-assisted orthopedic consultations to a remote clinic in Northern Norway, rather than having patients travel to the specialist hospital for consultations, is cost-effective from both a societal and health sector perspective. This conclusion holds as long as the activity exceeds 151 and 183 patient consultations per year, respectively.Trial registrationClinicalTrials.gov NCT00616837; https://clinicaltrials.gov/ct2/show/NCT00616837 (Archived by WebCite at http://www.webcitation.org/762dZPoKX).

Project description:Background/aimsMany investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies).MethodsIn collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process.ResultsA total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process (p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process.ConclusionThis randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.

Dataset Information

Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial.

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Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial.

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