Influence of a Preadmission Procedure-Specific Consent Document on Patient Recall of Informed Consent at 4 Weeks After Total Hip Replacement: A Randomized Controlled Trial

Abstract

Objectives: Consent is a legal and ethical requirement for undertaking surgical procedures; however, the literature suggests that there continues to be poor recall among patients of the surgical risks discussed during the consent process. The aim of this study was to evaluate whether the addition of a preadmission procedure-specific consent document would improve patient recall of surgical risks at 4 weeks after total hip replacement in patients consented with a procedure-specific consent form.

Methods: A prospective randomized controlled trial allocated seventy adult patients who were undergoing a primary total hip replacement to either receive (intervention group) or not receive (control group) a preadmission procedure-specific consent document. All patients were also consented with a procedure-specific consent form on the morning of surgery and were contacted 4 weeks later to assess recall of surgical risks.

Results: There was a very poor recall rate seen in both the intervention group (16%) and the control group (13%), with no statistically significant difference between them (P = 0.49). A large number (30%) of patients could not recall a single risk. A subgroup analysis excluding these "consent nonresponders" did show a significantly increased recall rate in the intervention group (24.5% versus 18.25%, P = 0.02).

Conclusions: Patient recall of potential complications of total hip replacement was poor despite the intervention. Although not effective overall, the use of a preadmission procedure-specific consent document did improve recall of potential complications of surgery in a subset of patients. The phenomenon of consent nonresponders is worth exploring in future research.