Browsing by Author "Krieger, Janice L."

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    Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial
    (Oxford University Press, 2019-07) Harle, Christopher A.; Golembiewski, Elizabeth H.; Rahmanian, Kiarash P.; Brumback, Babette; Krieger, Janice L.; Goodman, Kenneth W.; Mainous, Arch G., III; Moseley, Ray E.; Health Policy and Management, School of Public Health
    Objective In the context of patient broad consent for future research uses of their identifiable health record data, we compare the effectiveness of interactive trust-enhanced e-consent, interactive-only e-consent, and standard e-consent (no interactivity, no trust enhancement). Materials and Methods A randomized trial was conducted involving adult participants making a scheduled primary care visit. Participants were randomized into 1 of the 3 e-consent conditions. Primary outcomes were patient-reported satisfaction with and subjective understanding of the e-consent. Secondary outcomes were objective knowledge, perceived voluntariness, trust in medical researchers, consent decision, and time spent using the application. Outcomes were assessed immediately after use of the e-consent and at 1-week follow-up. Results Across all conditions, participants (N = 734) reported moderate-to-high satisfaction with consent (mean 4.3 of 5) and subjective understanding (79.1 of 100). Over 94% agreed to share their health record data. No statistically significant differences in outcomes were observed between conditions. Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting. Conclusions A large majority of patients were willing to share their identifiable health records for research, and they reported positive consent experiences. However, incorporating optional additional information and messages designed to enhance trust in the research process did not improve consent experiences. To improve poorer consent experiences of racial and ethnic minority participants and those with lower education, other novel consent technologies and processes may be valuable.
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    Patient preferences toward an interactive e-consent application for research using electronic health records
    (Oxford University Press, 2017-12-19) Harle, Christopher A.; Golembiewski, Elizabeth H.; Rahmanian, Kiarash P.; Krieger, Janice L.; Hagmajer, Dorothy; Mainous III, Arch G.; Moseley, Ray E.; Health Policy and Management, School of Public Health
    Objective: The purpose of this study was to assess patient perceptions of using an interactive electronic consent (e-consent) application when deciding whether or not to grant broad consent for research use of their identifiable electronic health record (EHR) information. Materials and Methods: For this qualitative study, we conducted a series of 42 think-aloud interviews with 32 adults. Interview transcripts were coded and analyzed using a modified grounded theory approach. Results: We identified themes related to patient preferences, reservations, and mixed attitudes toward consenting electronically; low- and high-information-seeking behavior; and an emphasis on reassuring information, such as data protections and prohibitions against sharing data with pharmaceutical companies. Participants expressed interest in the types of information contained in their EHRs, safeguards protecting EHR data, and specifics on studies that might use their EHR data. Discussion: This study supports the potential value of interactive e-consent applications that allow patients to customize their consent experience. This study also highlights that some people have concerns about e-consent platforms and desire more detailed information about administrative processes and safeguards that protect EHR data used in research. Conclusion: This study contributes new insights on how e-consent applications could be designed to ensure that patients' information needs are met when seeking consent for research use of health record information. Also, this study offers a potential electronic approach to meeting the new Common Rule requirement that consent documents contain a "concise and focused" presentation of key information followed by more details.
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    Perspectives of Pregnant and Breastfeeding Women on Participating in Longitudinal Mother-Baby Studies Involving Electronic Health Records: Qualitative Study
    (JMIR, 2021-03-05) Hentschel, Austen; Chen, Lynn Y.; Wright, Lauren; Shaw, Jennifer; Du, Xinsong; Flood-Grady, Elizabeth; Harle, Christopher A.; Reeder, Callie F.; Francois, Magda; Louis-Jacques, Adetola; Shenkman, Elizabeth; Krieger, Janice L.; Lemas, Dominick J.; Health Policy and Management, Richard M. Fairbanks School of Public Health
    Background: Electronic health records (EHRs) hold great potential for longitudinal mother-baby studies, ranging from assessing study feasibility to facilitating patient recruitment to streamlining study visits and data collection. Existing studies on the perspectives of pregnant and breastfeeding women on EHR use have been limited to the use of EHRs to engage in health care rather than to participate in research. Objective: The aim of this study is to explore the perspectives of pregnant and breastfeeding women on releasing their own and their infants' EHR data for longitudinal research to identify factors affecting their willingness to participate in research. Methods: We conducted semistructured interviews with pregnant or breastfeeding women from Alachua County, Florida. Participants were asked about their familiarity with EHRs and EHR patient portals, their comfort with releasing maternal and infant EHR data to researchers, the length of time of the data release, and whether individual research test results should be included in the EHR. The interviews were transcribed verbatim. Transcripts were organized and coded using the NVivo 12 software (QSR International), and coded data were thematically analyzed using constant comparison. Results: Participants included 29 pregnant or breastfeeding women aged between 22 and 39 years. More than half of the sample had at least an associate degree or higher. Nearly all participants (27/29, 93%) were familiar with EHRs and had experience accessing an EHR patient portal. Less than half of the participants (12/29, 41%) were willing to make EHR data available to researchers for the duration of a study or longer. Participants' concerns about sharing EHRs for research purposes emerged in 3 thematic domains: privacy and confidentiality, transparency by the research team, and surrogate decision-making on behalf of infants. The potential release of sensitive or stigmatizing information, such as mental or sexual health history, was considered in the decisions to release EHRs. Some participants viewed the simultaneous use of their EHRs for both health care and research as potentially beneficial, whereas others expressed concerns about mixing their health care with research. Conclusions: This exploratory study indicates that pregnant and breastfeeding women may be willing to release EHR data to researchers if researchers adequately address their concerns regarding the study design, communication, and data management. Pregnant and breastfeeding women should be included in EHR-based research as long as researchers are prepared to address their concerns.
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    Typology of delivery quality: latent profile analysis of teacher engagement and delivery techniques in a school-based prevention intervention, keepin' it REAL curriculum
    (Oxford University Press, 2014-12) Shin, YoungJu; Miller-Day, Michelle; Pettigrew, Jonathan; Hecht, Michael L.; Krieger, Janice L.; Department of Communications Studies, School of Liberal Arts
    Enhancing the delivery quality of school-based, evidence-based prevention programs is one key to ensuring uniform program effects on student outcomes. Program evaluations often focus on content dosage when implementing prevention curricula, however, less is known about implementation quality of prevention content, especially among teachers who may or may not have a prevention background. The goal of the current study is to add to the scholarly literature on implementation quality for a school-based substance use prevention intervention. Twenty-five schools in Ohio and Pennsylvania implemented the original keepin' REAL (kiR) substance use prevention curriculum. Each of the 10, 40-45 min lessons of the kiR curriculum was video recorded. Coders observed and rated a random sample of 276 videos reflecting 78 classes taught by 31 teachers. Codes included teachers' delivery techniques (e.g., lecture, discussion, demonstration and role play) and engagement with students (e.g. attentiveness, enthusiasm and positivity). Based on the video ratings, a latent profile analysis was run to identify typology of delivery quality. Five profiles were identified: holistic approach, attentive teacher-orientated approach, enthusiastic lecture approach, engaged interactive learning approach and skill practice-only approach. This study provides a descriptive typology of delivery quality while implementing a school-based substance use prevention intervention.