Bundled Consent in US Intensive Care Units.
Maria L Espinosa, Aaron M Tannenbaum, Megha Kilaru and 4 others
PMID 32355968WHAT IT FOUND
ICUs using bundled consent for multiple procedures reported performing fewer invasive procedures without documented consent than those using per-procedure consent.
All bundled-consent respondents recommended the practice, though results rely on self-report and do not measure consent quality or patient understanding.
Key findings
01Respondents in ICUs using per-procedure consent were significantly more likely to report performing invasive procedures without documented consent compared to those using bundled consent.
02All respondents from hospitals using bundled consent recommended the practice to other institutions, and nearly half of those using per-procedure consent expressed interest in adopting it.
03Formal training on how to discuss informed consent was rare overall but significantly more common in units using bundled consent.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The primary outcome was self-reported, which introduces social desirability bias; respondents may have overestimated their compliance with consent protocols. The study did not measure the quality of the consent conversation or whether patients and families actually understood the risks and benefits. Most respondents were nurses, which reflects real-world practice but may limit the generalizability of physician-specific perspectives on legal liability or communication preferences. The cross-sectional design cannot prove that bundled consent causes higher consent rates; units that adopt bundled consent may differ in other ways not captured by the survey.
Declared interests
The study protocol was deemed exempt by the University of Chicago IRB. No specific financial conflicts of interest or funding sources are detailed in the provided text.
The easy way to misread this
Do not interpret the higher rate of documented consent in bundled-consent units as evidence that patients understand the procedures better. The study measured only whether consent was documented, not the quality of the conversation or patient comprehension.