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Fink AS (Atlanta VAMC), Prochazka AV
(Denver VAMC), Henderson WG
(University of Colorado Health Outcomes Program), Bartenfeld DH
(Atlanta VAMC), Nyirenda C
(University of Colorado Health Outcomes Program), Itani K
(Boston VAMC), Webb AL
(Atlanta VAMC), Parmelee PA
(University of Alabama at Birmingham), Bottrell MM
(National Center for Ethics in Healthcare), Rosendale DE
(VHA Washington, DC, OIFO)
Objectives:
Patient comprehension of informed consent (IC) for surgical procedures is limited. Asking patients to "Repeat Back" (RB) key points from the consent has been proposed. This study was designed to test RB’s effectiveness on IC comprehension.
Methods:
Patients scheduled for elective surgeries (total hip arthroplasty (n = 120), carotid endarterectomy (n = 154), laparoscopic cholecystectomy (n = 168), or radical prostatectomy (n = 76)) at 7 VA Medical Centers were enrolled. IC was obtained using iMedConsent, the VA's computer-based IC platform. Patients were randomized to RB (a module added to the iMedConsent package) or standard iMedConsent (STD). In the RB group, the consent could not be completed until the surgeon received satisfactory responses regarding critical procedural elements. Health status was assessed using SF-12v and reading ability with the REALM. Comprehension was tested immediately after the IC discussion using procedure-specific questionnaires (23-26 items, score range 0-100% correct). Provider satisfaction (+/- RB) and patient satisfaction with decision making were measured using 5 point Likert scales (1 worst and 5 best). Time stamps in the iMedConsent program estimated the time spent completing the IC process (+/- RB). Statistical comparisons of groups were performed using t-tests and Chi Square tests.
Results:
518 patients (250 RB and 268 STD) were enrolled; 93% were male and 89% had at least a high school education. The mean age was 61.8 (sd 10.6), mean SF-12 Physical 35.8 (sd 12.6), SF-12 Mental 50.0 (sd 12.7), and mean REALM 62.3 (sd 6.9) indicating high school reading ability level. In the RB group, providers spent 4.4 minutes longer (13.6 RB vs 9.2 minutes STD, p = 0.001) obtaining IC. The mean comprehension score was significantly higher in the RB group (72% RB vs 67% STD, p = 0.0039). The greatest effect was in the carotid endarterectomy group (mean comprehension 74% RB vs 65% STD, p = 0.0004). Quality of decision making was rated similarly (4.74 RB vs 4.74 STD, p = 0.93). Providers were neutral to slightly favorable in their rating of RB (3.45).
Implications:
RB implemented within an electronic informed consent system improved patient comprehension. The additional time required was acceptable to providers.
Impacts:
RB should be considered as a standard enhancement to surgical informed consent.
