3081 — Telling the Truth: Do the VA’s Procedure-Specific Informed Consent Documents Specify the Information Actually Discussed between Surgeons and Patients?
Hall DE, CHERP, VA Pittsburgh Healthcare System; Hanusa BH, CHERP, VA Pittsburgh Healthcare System; Fine MJ, CHERP, VA Pittsburgh Healthcare System; Arnold RM, University of Pittsburgh;
High quality documentation of the informed consent process should specify the information actually discussed between surgeons and patients. iMedConsent is VA’s computer-based tool for generating standardized, procedure-specific consent documents. We examined how the iMed documents correspond to the information discussed between surgeons and patients.
We enrolled 75 of165 Veterans presenting consecutively to a general surgery clinic for possible cholecystectomy or inguinal herniorrhaphy from October 2009 to August 2010. Surgery was recommended for 42 patients, and they all documented consent with iMed. Each patient carried a recording device during the clinic visit that captured the patient-provider interactions. Using an open, iterative method, we developed a codebook containing each distinct piece of information printed on the iMed documents or discussed on the audiotapes. A single trained analyst coded the information in each audiotape and each iMed document. We used Wilcoxon signed-rank tests to compare differences between the audiotapes and iMed documents with regard to the number of codes.
The amount of information printed on the iMed documents exceeded the amount of information discussed in the audiotapes for risks (p <=.0002), benefits (p <=.008), alternatives (p <=.036), reasons for (p <=.001), and descriptions of (p <=.0001) both cholecystectomy and herniorrhaphy. For example, the number of risks documented for cholecystectomy (median = 18) exceeded the number of risks discussed (median = 8, p <.0001). However, providers routinely discussed likely peri-operative experiences even though this information was never included in the iMed documents (p <=.0001). 50% of cholecystectomy discussions (11/22) mentioned at least one risk, benefit, alternative, reason for and description of the procedure. Alternatives to herniorrhaphy were rarely mentioned (15%), but 55% of herniorrhaphy discusssions (11/20) mentioned at least one risk, benefit, reason for and description of herniorrhaphy.
iMed documents contain more detailed information about risks, benefits and alternatives than surgeons discuss with their patients. However, surgeons discuss more information about patients’ peri-operative experiences than is found on the iMed documents.
The quality of informed consent documentation might be improved by adapting the iMed tool to ask providers to specify information discussed from a standardized list, so that the document in the patient’s record more closely corresponds to the actual informed consent discussion.