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Newman JE, Clarke L, Athimuthu P, Dhawan M, Owen S, Beiersdorfer T, Parlberg LM, Bangdiwala A, McMillan T, DeMauro SB, Lorch S, Peralta-Carcelen M, Wilson-Costello D, Ambalavanan N, Merhar S, Poindexter B, Limperopoulos C, Davis JM, Walsh M, Bann CM
Supplementing Consent for a Prospective Longitudinal Cohort Study of Infants With Antenatal Opioid Exposure: Development and Assessment of a Digital Tool
Digital Tool to Supplement Consent for a Prospective Longitudinal Cohort Study of Infants with Antenatal Opioid Exposure: Development and Assessment
Jamie E. Newman;
Leslie Clarke;
Pranav Athimuthu;
Megan Dhawan;
Sharon Owen;
Traci Beiersdorfer;
Lindsay M. Parlberg;
Ananta Bangdiwala;
Taya McMillan;
Sara B. DeMauro;
Scott Lorch;
Myriam Peralta-Carcelen;
Deanne Wilson-Costello;
Namasivayam Ambalavanan;
Stephanie Merhar;
Brenda Poindexter;
Catherine Limperopoulos;
Jonathan M. Davis;
Michele Walsh;
Carla M. Bann
ABSTRACT
Background:
The Outcomes of Babies with Opioid Exposure (OBOE) Study examines the impact of antenatal opioid exposure on outcomes from birth to 2 years of age. Social distancing measures in response to the COVID-19 pandemic presented challenges to research coordinators discussing the study at length with potential participants during the birth hospitalization, which impacted recruitment, particularly among mothers of unexposed (control) infants. In response, the OBOE Study developed an interactive digital tool (Consenter video) to supplement the informed consent process and make it more engaging for potential participants.
Objective:
To examine knowledge of the study, experiences with the consent process, and perceptions of the Consenter video among potential participants of the OBOE Study.
Methods:
Analyses included 129 mothers/caregivers who were given the option to view the Consenter video as a supplement to the consent process. Participants selected from three racially and ethnically diverse avatars to guide them through the 11-minute video with recorded voiceovers. After viewing the Consenter video, participants completed a short survey to assess their knowledge of the study, experiences with the consent process, and perceptions of the tool, regardless of their consent decision.
Results:
Participants demonstrated good understanding of the information presented, with 95% correctly identifying the purpose of the study and 88% correctly indicating that their infant would not be exposed to radiation during the MRI. Nearly all indicated they were provided “just the right amount of information” (98%) and that they understood the consent information well enough to decide whether to enroll (96%). Of 81 respondents with known race/ethnicity, 35 (43%) chose avatars to guide them through the video that matched their background.
Conclusions:
This interactive digital tool was helpful in informing prospective participants about the study. Consenter enhanced the informed consent process, reinforced why mothers of unexposed infants were being approached, and was particularly helpful as a resource for families to understand MRI procedures. Clinical Trial: ClinicalTrials.gov NCT04149509
Citation
Please cite as:
Newman JE, Clarke L, Athimuthu P, Dhawan M, Owen S, Beiersdorfer T, Parlberg LM, Bangdiwala A, McMillan T, DeMauro SB, Lorch S, Peralta-Carcelen M, Wilson-Costello D, Ambalavanan N, Merhar S, Poindexter B, Limperopoulos C, Davis JM, Walsh M, Bann CM
Supplementing Consent for a Prospective Longitudinal Cohort Study of Infants With Antenatal Opioid Exposure: Development and Assessment of a Digital Tool