Abstract 15108: Patient Centered Approaches to Research Enrollment (P-CARE)
Introduction: Emergent informed consent for clinical trials in acute myocardial infarction (MI) and stroke is complicated by time pressure, severe illness, and stress. Insufficient data exist regarding patients’ and surrogates’ experiences of emergent consent. Such data may help to maximize respect for patients while facilitating important trials.
Methods: We interviewed patients (or surrogates if surrogate provided consent) enrolled in ST-elevation MI or stroke trials at 3 sites from 2011-2016. These structured telephone interviews included domains for trial recall, perceptions of the consent process, and preferences regarding involvement. Questions were primarily closed-ended with some open-ended probes. Descriptive and test statistics (chi-square and Fisher’s exact tests) were used to characterize responses and explore relationships between key domains and the condition under study.
Results: 58 participants from stroke trials (47 surrogates and 11 patients) and 47 participants from MI trials (all patients) were interviewed. 6 stroke and 15 MI participants did not recall being in a trial. Among 84 participants who did recall participation, most felt they were treated appropriately during consent (Table 1). Participants in MI trials recalled the process being shorter than their stroke counterparts; they were also less likely to report reading the consent form or asking questions before enrolling. The large majority appreciated being asked for permission before study inclusion. Many participants did not recall anyone talking with them about the study after enrollment.
Conclusions: Participants in acute MI and stroke trials generally reported positive experiences with emergent consent. Despite challenges intrinsic to these decisions, most participants appreciate being asked for permission before enrollment. Opportunities for improvement exist to better contextualize these processes and improve communication after enrollment.
Author Disclosures: V.M. Scicluna: None. J.C. Blankenship: None. C.M. Devireddy: Consultant/Advisory Board; Modest; Scientific Advisory Board-Medtronic and Vascular Dynamics. M. Frankel: None. S.F. Goldkind: None. G. Kumar: None. Q. Long: Research Grant; Significant; NIH, PCORI, NSF, AHA, CFF. A.R. Mitchell: None. R.G. Nogueira: None. S. Noreen: None. R.M. Parker: None. M.R. Patel: None. R.D. Pentz: None. M. Riedford: Honoraria; Modest; Press Ganey Conference. R. Silbergleit: None. C. Speight: None. K.P. Weinfurt: None. N.W. Dickert: None.
- © 2016 by American Heart Association, Inc.