Abstract WP307: Patients’ and Surrogates’ Experiences and Views of Consent in Acute Stroke Trials

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Abstract

Introduction: Informed consent for clinical trials in acute stroke is challenging. Enrollment decisions must be made quickly, in stressful situations, and typically by a surrogate. Moreover, trials are complex and unfamiliar. Understanding patients’ and surrogates’ experiences may help maximize respect for them while facilitating important studies.

Methods: Telephone interviews were conducted with consented patients or surrogates for patients enrolled in acute stroke trials at 3 US sites between 2011 and 2016. Interviews assessed trial recall, experiences with consent, and preferences regarding consent. Questions were primarily closed-ended. Descriptive statistics were calculated, and bivariate analyses (Fisher’s exact) were conducted to examine predictors of consent preference.

Results: Eighty-four respondents (69 surrogates, 15 patients) across 3 sites and 10 trials were interviewed and included in final analysis. Nine did not recall enrollment, and only about half (53%) recalled that the trial involved an intervention. Of 75 respondents who remembered enrolling, 65 (87%) remembered signing a consent form, 52 (80%) of whom said they read at least some of it. Most respondents reported being treated respectfully during consent. Only 12 respondents (16%) wished they had been enrolled in the trial without prospective consent. Individuals with low health literacy were less likely to prefer enrollment without consent (p<0.0007) but more likely to wish they had not had to sign a consent form (p<0.0001). Forty-six (61%) recalled someone talking with them about the study after enrollment.

Conclusions: Patients and surrogates in stroke trials reported mostly positive consent experiences and generally appreciated having been asked for consent prior to enrollment. Recall of trial details, however, was low, and post-enrollment contact was recalled to be somewhat infrequent. Further work may help to identify the most context-appropriate strategies.

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