The Effect of the Consent Process on Patient Satisfaction With Pain Management: A Randomized Controlled Trial.

Abstract

We aim to determine whether the timing and context of informed consent affects the subjective outcome of patient satisfaction with pain management. We conducted a randomized controlled trial in a single emergency department (ED). Patients aged 18 years or older with a triage pain score of greater than or equal to 4 provided consent to participate in a pain management study. They were randomized to consent in the ED or at follow-up. All patients were followed up at 48 hours post-ED discharge. Patients who consented at follow-up were unaware of the study until cold called. The primary outcome was patient satisfaction with pain management. Secondary analyses examined effects on follow-up and participation rates. Variables associated with patients' being very satisfied were determined with multivariate logistic regression. Outcome data were obtained on 655 of 825 patients enrolled (79.4%). Patients who provided consent at follow-up were less likely to be very satisfied compared with those who consented in the ED (difference in proportions 11.5%; 95% confidence interval 3.5 to 19.4). Follow-up and participation rates did not differ between the groups. Patients who received pain advice and adequate analgesia (both as defined in this study) were more likely to be very satisfied (odds ratio 5.18, 95% confidence interval 2.82 to 9.52; and odds ratio 1.54, 95% confidence interval 1.07 to 2.22, respectively). The timing and context of informed consent significantly affect the subjective outcome of patient satisfaction, and this should be considered during study design. Clinicians should strive to provide pain advice and adequate analgesia to maximize their patients' satisfaction.