Enhancement of surgical informed consent by addition of repeat back: A multicenter, randomized controlled clinical trial

Aaron S. Fink, Allan V. Prochazka, William G. Henderson, Debra Bartenfeld, Carsie Nyirenda, Alexandra Webb, David H. Berger, Kamal Itani, Thomas Whitehill, James Edwards, Mark Wilson, Cynthia Karsonovich, Patricia Parmelee

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    62 Citations (Scopus)

    Abstract

    Objective: In this randomized, controlled, unblinded trial, we sought to test Repeat Back's (RB) effect on comprehension following informed consent discussions. Summary Background Data: RB has been suggested as a method to improve patient comprehension when obtaining informed consent. In this technique, patients are asked to recount what they have been told in the informed consent discussion. Despite preliminary data, this practice has not been evaluated in any large scale study. Methods: This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent, the VA's computer based platform. Patients scheduled for elective surgeries were randomized to RB (a module added to the iMedConsent package) or standard iMedConsent (no RB). Comprehension was tested after the informed consent using procedure-specific questionnaires. Time stamps in the iMedConsent program estimated the time spent completing the informed consent process. Provider and patient satisfaction were measured using 5-point Likert scales. Statistical comparisons of groups were performed using t-tests and χ tests. Results: A total of 575 patients were enrolled. In the RB group, providers spent 2.6 minutes longer (P <0.0001) obtaining informed consent. The mean comprehension score was significantly higher in the RB group (71.4%) versus the no RB group (68.2%, P = 0.03); the effect was greatest in carotid endarterectomy patients (RB = 73.4% vs. no RB = 67.7%, P = 0.02). Quality of decision making was rated similarly. Providers were neutral to slightly favorable regarding RB. Conclusions: RB implemented within an electronic informed consent system improved patient comprehension. The additional time required was acceptable to providers. RB should be considered as an enhancement to surgical informed consent.This clinical trial was registered at http://www.clinicaltrials.gov (Identifier NCT00288899).

    Original languageEnglish (US)
    Pages (from-to)27-36
    Number of pages10
    JournalAnnals of Surgery
    Volume252
    Issue number1
    DOIs
    StatePublished - Jul 2010

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    Informed Consent
    Randomized Controlled Trials
    Veterans Health
    United States Department of Veterans Affairs
    Carotid Endarterectomy
    Patient Satisfaction
    Decision Making
    Clinical Trials

    ASJC Scopus subject areas

    • Surgery

    Cite this

    Fink, A. S., Prochazka, A. V., Henderson, W. G., Bartenfeld, D., Nyirenda, C., Webb, A., ... Parmelee, P. (2010). Enhancement of surgical informed consent by addition of repeat back: A multicenter, randomized controlled clinical trial. Annals of Surgery, 252(1), 27-36. https://doi.org/10.1097/SLA.0b013e3181e3ec61

    Enhancement of surgical informed consent by addition of repeat back : A multicenter, randomized controlled clinical trial. / Fink, Aaron S.; Prochazka, Allan V.; Henderson, William G.; Bartenfeld, Debra; Nyirenda, Carsie; Webb, Alexandra; Berger, David H.; Itani, Kamal; Whitehill, Thomas; Edwards, James; Wilson, Mark; Karsonovich, Cynthia; Parmelee, Patricia.

    In: Annals of Surgery, Vol. 252, No. 1, 07.2010, p. 27-36.

    Research output: Contribution to journalArticle

    Fink, AS, Prochazka, AV, Henderson, WG, Bartenfeld, D, Nyirenda, C, Webb, A, Berger, DH, Itani, K, Whitehill, T, Edwards, J, Wilson, M, Karsonovich, C & Parmelee, P 2010, 'Enhancement of surgical informed consent by addition of repeat back: A multicenter, randomized controlled clinical trial', Annals of Surgery, vol. 252, no. 1, pp. 27-36. https://doi.org/10.1097/SLA.0b013e3181e3ec61
    Fink, Aaron S. ; Prochazka, Allan V. ; Henderson, William G. ; Bartenfeld, Debra ; Nyirenda, Carsie ; Webb, Alexandra ; Berger, David H. ; Itani, Kamal ; Whitehill, Thomas ; Edwards, James ; Wilson, Mark ; Karsonovich, Cynthia ; Parmelee, Patricia. / Enhancement of surgical informed consent by addition of repeat back : A multicenter, randomized controlled clinical trial. In: Annals of Surgery. 2010 ; Vol. 252, No. 1. pp. 27-36.
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    abstract = "Objective: In this randomized, controlled, unblinded trial, we sought to test Repeat Back's (RB) effect on comprehension following informed consent discussions. Summary Background Data: RB has been suggested as a method to improve patient comprehension when obtaining informed consent. In this technique, patients are asked to recount what they have been told in the informed consent discussion. Despite preliminary data, this practice has not been evaluated in any large scale study. Methods: This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent, the VA's computer based platform. Patients scheduled for elective surgeries were randomized to RB (a module added to the iMedConsent package) or standard iMedConsent (no RB). Comprehension was tested after the informed consent using procedure-specific questionnaires. Time stamps in the iMedConsent program estimated the time spent completing the informed consent process. Provider and patient satisfaction were measured using 5-point Likert scales. Statistical comparisons of groups were performed using t-tests and χ tests. Results: A total of 575 patients were enrolled. In the RB group, providers spent 2.6 minutes longer (P <0.0001) obtaining informed consent. The mean comprehension score was significantly higher in the RB group (71.4{\%}) versus the no RB group (68.2{\%}, P = 0.03); the effect was greatest in carotid endarterectomy patients (RB = 73.4{\%} vs. no RB = 67.7{\%}, P = 0.02). Quality of decision making was rated similarly. Providers were neutral to slightly favorable regarding RB. Conclusions: RB implemented within an electronic informed consent system improved patient comprehension. The additional time required was acceptable to providers. RB should be considered as an enhancement to surgical informed consent.This clinical trial was registered at http://www.clinicaltrials.gov (Identifier NCT00288899).",
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    AU - Prochazka, Allan V.

    AU - Henderson, William G.

    AU - Bartenfeld, Debra

    AU - Nyirenda, Carsie

    AU - Webb, Alexandra

    AU - Berger, David H.

    AU - Itani, Kamal

    AU - Whitehill, Thomas

    AU - Edwards, James

    AU - Wilson, Mark

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    N2 - Objective: In this randomized, controlled, unblinded trial, we sought to test Repeat Back's (RB) effect on comprehension following informed consent discussions. Summary Background Data: RB has been suggested as a method to improve patient comprehension when obtaining informed consent. In this technique, patients are asked to recount what they have been told in the informed consent discussion. Despite preliminary data, this practice has not been evaluated in any large scale study. Methods: This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent, the VA's computer based platform. Patients scheduled for elective surgeries were randomized to RB (a module added to the iMedConsent package) or standard iMedConsent (no RB). Comprehension was tested after the informed consent using procedure-specific questionnaires. Time stamps in the iMedConsent program estimated the time spent completing the informed consent process. Provider and patient satisfaction were measured using 5-point Likert scales. Statistical comparisons of groups were performed using t-tests and χ tests. Results: A total of 575 patients were enrolled. In the RB group, providers spent 2.6 minutes longer (P <0.0001) obtaining informed consent. The mean comprehension score was significantly higher in the RB group (71.4%) versus the no RB group (68.2%, P = 0.03); the effect was greatest in carotid endarterectomy patients (RB = 73.4% vs. no RB = 67.7%, P = 0.02). Quality of decision making was rated similarly. Providers were neutral to slightly favorable regarding RB. Conclusions: RB implemented within an electronic informed consent system improved patient comprehension. The additional time required was acceptable to providers. RB should be considered as an enhancement to surgical informed consent.This clinical trial was registered at http://www.clinicaltrials.gov (Identifier NCT00288899).

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