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Determinants of Patient and Surrogate Experiences With Acute Care Research Consent: A Key Informant Interview Study.

ABSTRACT: Background Informed consent for acute myocardial infarction and stroke research is challenging. Time for enrollment decisions is limited, patients and family are usually stressed, and being asked to participate in research is often unexpected. Despite these barriers, patients and surrogates have reported a preference for prospective involvement in research decisions and generally positive views of the consent process. It is unknown what drives positive or negative consent experiences. These data are crucial to making consent processes more context appropriate. Methods and Results We conducted a qualitative interview study with 27 patients and surrogates enrolled in acute myocardial infarction and stroke trials in the past 5 years. Purposive sampling from the P-CARE (Patient-Centered Approaches to Research Enrollment) study was based on participant characteristics and responses to initial patient-centered interviews. In-depth interviews used open-ended questions to explore factors influencing consent experiences. Qualitative descriptive analysis was performed utilizing a multilevel coding strategy. Participants identified specific researcher behaviors as important, including expressions of respect, professionalism, and nonpressuring communication. Participants preferred consent conversations focused on risks/benefits and the trial protocol. They had varying views of consent forms and communicated several reasons the form was valuable unrelated to informational content. Participants also valued postenrollment interactions as opportunities to ask questions and learn about the study. Conclusions Barriers to consent in acute myocardial infarction and stroke trials are unavoidable, but participants identified productive ways to demonstrate respect for patients during enrollment conversations. These include key researcher behaviors, concentrating consent discussions on what participants find most important, and structured postenrollment follow-up.

SUBMITTER: Scicluna VM

PROVIDER: S-EPMC6915273 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Determinants of Patient and Surrogate Experiences With Acute Care Research Consent: A Key Informant Interview Study.

Scicluna Victoria M VM Goldkind Sara F SF Mitchell Andrea R AR Pentz Rebecca D RD Speight Candace D CD Silbergleit Robert R Dickert Neal W NW

Journal of the American Heart Association 20191108 22

Background Informed consent for acute myocardial infarction and stroke research is challenging. Time for enrollment decisions is limited, patients and family are usually stressed, and being asked to participate in research is often unexpected. Despite these barriers, patients and surrogates have reported a preference for prospective involvement in research decisions and generally positive views of the consent process. It is unknown what drives positive or negative consent experiences. These data ...[more]

PMID: 31698980

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Project description:BackgroundMaternal morbidity and mortality in the United States continue to be a worsening public health crisis, with persistent racial disparities among Black women during the COVID-19 pandemic. Innovations in mobile health (mHealth) technology are being developed as a strategy to connect birthing women to their health care providers during the first 6 weeks of the postpartum period.ObjectiveThis study aimed to inform a process to evaluate the barriers to mHealth implementation in the context of the COVID-19 pandemic by exploring the experiences of mothers and stakeholders who were directly involved in the pilot program.MethodsThe qualitative design used GoToMeeting (GoTo) individual interviews of 13 mothers and 7 stakeholders at a suburban teaching hospital in New Jersey. Mothers were aged ≥18 years, able to read and write in English or Spanish, had a vaginal or cesarean birth at >20 weeks of estimated gestational age, and were admitted for delivery at the hospital with at least a 24-hour postpartum stay. Stakeholders were part of the hospital network's obstetrics collaborative subcommittee comprising administrators, physicians, registered nurses, and informatics. Responses were transcribed verbatim and analyzed for emerging themes. The socioecological framework provided a holistic lens for analyzing the multilevel influences on individual experiences.ResultsA total of 3 major themes were identified: mothers experienced barriers from personal situations at home and with services in the hospital and community, which were intensified by the COVID-19 pandemic; the COVID-19 pandemic negatively impacted hospital services, priorities, and individual staff; and mothers and stakeholders had positive experiences and perceptions of the mHealth intervention.ConclusionsThe use and reach of the mHealth intervention were negatively influenced by interrelated factors operating at multiple levels. The system-wide and multilevel impact of the pandemic was reflected in participants' responses, providing evidence for the need to re-evaluate mHealth implementation with more adaptable systems and structures in place using a socioecological framework.

Project description:Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research.A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008.None.Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults.Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives.Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.

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Determinants of Patient and Surrogate Experiences With Acute Care Research Consent: A Key Informant Interview Study.

Publications

Determinants of Patient and Surrogate Experiences With Acute Care Research Consent: A Key Informant Interview Study.

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