Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a...

Area of Science:

• Medical Informatics
• Patient Safety
• Health Law and Ethics

Background:

• Updated regulatory guidelines emphasize shared decision making (SDM) for informed consent.
• Paper-based consent forms are prone to errors in completion, legibility, and content omission.
• A digital consent process was developed to address these limitations.

Purpose of the Study:

• To compare the quality of digital consent forms against traditional paper-based forms.
• To evaluate patient-reported involvement in shared decision making (SDM) between the two methods.
• To assess the error rates and omission of core risks in digital versus paper consent documentation.

Main Methods:

• A multi-site, single-center study included 223 patients.
• Patients provided consent via paper forms or the Concentric digital consent platform.
• Forms were analyzed for errors, and core risks for 20 orthopaedic operations were assessed for omission. SDM was measured using the 'collaboRATE Top Score'.

Main Results:

• Digital consent forms had 0% errors, while 72% of paper forms had errors (P < 0.0001).
• Core risks were omitted in <2% of digital forms versus 63% of paper forms (P < 0.0001).
• 72% of patients using digital consent reported gold-standard SDM, compared to 28% with paper consent (P < 0.001).

Conclusions:

• Digital consent processes significantly reduce errors and omissions of core risks.
• Implementation of digital consent enhances the quality of SDM and informed consent.
• Digital consent improves the overall patient experience regarding shared decision making.