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CDA 08-281 – HSR&D Study

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CDA 08-281
Improving Surgical Informed Consent to Better Meet Patient Preference
Daniel E. Hall MD MDiv MHSc
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, PA
Funding Period: July 2010 - June 2015

BACKGROUND/RATIONALE:
The VA seeks and documents informed consent (IC) over 1 million times each year for the surgical care of Veterans, and to facilitate this process, the VA has implemented a computerized decision-aid called "iMedConsent". However, little research has examined how this tool is used in practice or how it affects the IC process.

OBJECTIVE(S):
(1) To describe how patients and surgeons use iMed to make decisions about surgery; (2) to measure the quality of the iMed IC process; and, ultimately, (3) to develop interventions to maximize the potential of iMed to promote high quality informed decision making. These objectives will be addressed in 2 sequential prospective cohort studies.

METHODS:
Study 1 enrolled a cohort of 42 patients from the general surgery clinic at VA Pittsburgh to (1) describe how VA providers and patients use iMed to obtain and document IC for inguinal herniorrhaphy and cholecystectomy; (2) compare the information documented in the iMed IC form with the information discussed by the surgical provider; and (3) explore changes in patient comprehension of procedure-specific risks, benefits and alternatives before and after using iMed. Patients and providers each participated in semi-structured telephone interviews asking about their experience with IC. The discussions between patients and surgical provider(s) were recorded. Patients completed questionnaires before and after documenting consent with iMed.

Study 2 will enroll a cohort of 400-500 patients from 3 VA sites to: (1) measure changes before and after using iMed to document IC in knowledge, attitudes and anxiety; (2) explore how patient demographics and information preferences affect patient comprehension, ambivalence, trust and anxiety; and (3) explore how the information explicitly discussed between patients and providers explains the changes measured in patient comprehension, ambivalence, trust and anxiety.

FINDINGS/RESULTS:
Not yet available.

IMPACT:
The proposed research developed a sophisticated understanding of how VA providers and patients use iMed to document IC. By measuring changes in variables relevant to IC quality, including information preferences, it may be possible design and test an intervention to improve IC quality.

PUBLICATIONS:

Journal Articles

  1. Morales A, Schultz KC, Gao S, Murphy A, Barnato AE, Fanning JB, Hall DE. Cultures of Practice: Specialty-Specific Differences in End-of-Life Conversations. Palliative medicine reports. 2021 Mar 1; 2(1):71-83.
  2. Hall DE, Arya S, Schmid KK, Carlson MA, Lavedan P, Bailey TL, Purviance G, Bockman T, Lynch TG, Johanning JM. Association of a Frailty Screening Initiative With Postoperative Survival at 30, 180, and 365 Days. JAMA surgery. 2017 Mar 1; 152(3):233-240.
  3. Hall DE, Arya S, Schmid KK, Blaser C, Carlson MA, Bailey TL, Purviance G, Bockman T, Lynch TG, Johanning J. Development and Initial Validation of the Risk Analysis Index for Measuring Frailty in Surgical Populations. JAMA surgery. 2017 Feb 1; 152(2):175-182.
  4. Hall DE, Hanusa BH, Fine MJ, Arnold RM. Do surgeons and patients discuss what they document on consent forms? The Journal of surgical research. 2015 Jul 1; 197(1):67-77.
  5. Hall DE, Hanusa BH, Stone RA, Ling BS, Arnold RM. Time required for institutional review board review at one Veterans Affairs medical center. JAMA surgery. 2015 Feb 1; 150(2):103-9.
  6. Ernst KF, Hall DE, Schmid KK, Seever G, Lavedan P, Lynch TG, Johanning JM. Surgical palliative care consultations over time in relationship to systemwide frailty screening. JAMA surgery. 2014 Nov 1; 149(11):1121-6.
  7. Antiel RM, Reed DA, Van Arendonk KJ, Wightman SC, Hall DE, Porterfield JR, Horvath KD, Terhune KP, Tarpley JL, Farley DR. Effects of duty hour restrictions on core competencies, education, quality of life, and burnout among general surgery interns. JAMA surgery. 2013 May 1; 148(5):448-55.
  8. Ai AL, Hall D, Pargament K, Tice TN. Posttraumatic growth in patients who survived cardiac surgery: the predictive and mediating roles of faith-based factors. Journal of behavioral medicine. 2013 Apr 1; 36(2):186-98.
  9. Hall DE, Morrison P, Nikolajski C, Fine M, Arnold R, Zickmund SL. Informed consent for inguinal herniorrhaphy and cholecystectomy: describing how patients make decisions to have surgery. American journal of surgery. 2012 Nov 1; 204(5):619-25.
  10. Hall DE, Hanusa BH, Switzer GE, Fine MJ, Arnold RM. The impact of iMedConsent on patient decision-making regarding cholecystectomy and inguinal herniorrhaphy. The Journal of surgical research. 2012 Jun 15; 175(2):227-33.
  11. Antiel RM, Van Arendonk KJ, Reed DA, Terhune KP, Tarpley JL, Porterfield JR, Hall DE, Joyce DL, Wightman SC, Horvath KD, Heller SF, Farley DR. Surgical training, duty-hour restrictions, and implications for meeting the Accreditation Council for Graduate Medical Education core competencies: views of surgical interns compared with program directors. Archives of surgery (Chicago, Ill. : 1960). 2012 Jun 1; 147(6):536-41.
  12. Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ: Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne. 2012 Mar 20; 184(5):533-40.
  13. Brewster LP, Palmatier J, Manley CJ, Hall DE, Brems JJ. Limitations on surrogate decision-making for emergent liver transplantation. The Journal of surgical research. 2012 Jan 1; 172(1):48-52.
  14. Brewster LP, Hall DE, Joehl RJ. Assessing residents in surgical ethics: we do it a lot; we only know a little. The Journal of surgical research. 2011 Dec 1; 171(2):395-8.
  15. Neal MD, Alverdy JC, Hall DE, Simmons RL, Zuckerbraun BS. Diverting loop ileostomy and colonic lavage: an alternative to total abdominal colectomy for the treatment of severe, complicated Clostridium difficile associated disease. Annals of surgery. 2011 Sep 1; 254(3):423-7; discussion 427-9.
  16. Ai AL, Hall DE. Divine love and deep connections: a long-term followup of patients surviving cardiac surgery. Journal of aging research. 2011 Jun 15; 2011:841061.
  17. Hall DE. The guild of surgeons as a tradition of moral enquiry. The Journal of medicine and philosophy. 2011 May 16; 36(2):114-32.
  18. Thirunavukarasu P, Brewster LP, Pecora SM, Hall DE. Educational intervention is effective in improving knowledge and confidence in surgical ethics-a prospective study. American journal of surgery. 2010 Nov 1; 200(5):665-9.
Journal Other

  1. Johanning JM, Hall D, Arya S. Frailty and Mortality After Noncardiac Surgery in Elderly Individuals: Metrics, Systems, and the Elephant. JAMA surgery. 2016 Jun 1; 151(6):545-6.
  2. Morreim H, Antiel RM, Zacharias DG, Hall DE. Should age be a basis for rationing health care? The virtual mentor : VM. 2014 May 1; 16(5):339-47.
Book Chapters

  1. Hall DE, Angelos P, Dunn G, Hinshaw D, Pawlik T. Ethics, palliative care, and care at the end of life. In: Brunicardi F, Anderson D, Billiar T, Dunn D, Hunter J, Matthews J, Pollock zR, editors. Schwartz's Principles of Surgery. 10 ed. McGraw-Hill Education; 2014. 1941-54 p.
  2. Hall DE, Arnold RM, Lidz CW. Clinical aspects of consent in health care. In: Bioethics. 4 ed. Macmillan Reference USA; 2014. eBook. 3535 p.
Center Products

  1. Hall DE, Arya S. Current concepts in surgical frailty: systematic review and interventions for frailty [didactic session webinar for the Surgical Outcomes Club/Association of Academic Surgeons/Society of University Surgeons]. 2015 Apr 23.
  2. Hall DE. IRB quality and efficiency (Office of Research Oversight Live Meeting). 2015 Jan 13.
  3. Hall DE. Who decides when the patient cannot? (Multimedia Peer-Reviewed Module for the American Board of Surgery SCORE Curriculum). 2014 Jul 1.
  4. Hall DE. Describing IRB efficiency, quality and procedures: an interim report [Invited Presentation to VA Office of Research and Development]. 2013 Oct 9.
VA Cyberseminars

  1. Hall DE. Examining medical ethics through the lens of health services research. [Cyberseminar]. 2015 Feb 10.
Conference Presentations

  1. Hall DE, Purviance G, Prelerson J, Schmid KK, Varley P, Lynch T, Johanning J. Preliminary Validation of the Risk Analysis Index (RAI) of Frailty. Paper presented at: Association of VA Surgeons Annual Meeting; 2016 Apr 10; Virginia Beach, VA.
  2. Freeman M, Varley P, Hall DE, Lynch T, Edes T, Schmid KK, Arya S, Purviance G, Wilson M, Malhotra G, Johanning J. Feasibility of a Rapid, Objective Multi-Metric Frailty Assessment for Clinical Practice Settings. Paper presented at: Association of VA Surgeons Annual Meeting; 2016 Apr 9; Virginia Beach, VA.
  3. Moreno JD, Hall DE, Antiel RM, Koski G. Ethical Issues in Surgical Innovation and Research. Presented at: American Society for Bioethics and Humanities Annual Meeting; 2015 Oct 22; Houston, TX.
  4. Hall DE. The frailty assessment: what tool(s) to use. Paper presented at: Association of VA Surgeons Annual Meeting; 2015 May 4; Miami Beach, FL.
  5. Klune R, Feske U, Stone RA, Hanusa BH, Gao S, Zhang S, Ling BS, Lidz C, Switzer GE, Dobalian A, Arnold RM, Hall DE. Prioritizing initiatives for IRB quality improvement. Paper presented at: VA Association of Surgeons Annual Meeting; 2015 May 3; Miami, FL.
  6. Antiel RM, Lorish P, Bishop JP, Hall DE. Ethics and Emergence: The Facts of the Case. Paper presented at: Medicine and Religion Annual Conference; 2015 Mar 7; Boston, MA.
  7. Antiel RM, Lorish P, Bishop JP, Hall DE. Ethics and Emergence: The Facts of the Case. Presented at: American Society for Bioethics and Humanities Annual Meeting; 2014 Oct 17; San Diego, CA.
  8. Hall DE, Hausmann LR, Fine MJ. Intervening equitably to eliminate health care disparities. Paper presented at: American Society of Biomechanics Annual Meeting; 2014 Oct 17; San Diego, CA.
  9. Hall DE. Faith in the practice of medicine: why religion matters for the decisions physicians face. Paper presented at: Baylor University Institute for Faith and Learning Medical Ethics Banquet; 2014 Oct 10; Waco, TX.
  10. Hall DE, Hanusa BH, Fine MJ, Arnold RM. The time required for IRB review at one VA Medical Center. Paper presented at: VA Association of Surgeons Annual Meeting; 2014 Apr 6; New Haven, CT.
  11. Bishop J, Hall DE, VanderWeele T, Balboni T. Using empirical research to study religion, spirituality, and their relationship to medicine. Presented at: Medicine and Religion Annual Conference; 2014 Mar 8; Chicago, IL.
  12. Volk B, Volk J, Shuman J, Hall DE. Rendering the body in poetry, art and medicine. Presented at: Medicine and Religion Annual Conference; 2014 Mar 8; Chicago, IL.
  13. Hall DE, Hanusa BH, Fine MJ, Arnold RM. Documents and discussions: do the VA’s procedure-specific informed consent documents specify the information actually discussed between surgeons and patients? Paper presented at: Academic Surgical Congress; 2014 Feb 5; San Diego, CA.
  14. Hall DE, Berlin A. Case 4 - Ethics Colloquium: End of Life Issues in Surgery. Presented at: American College of Surgeons Annual Clinical Congress; 2013 Oct 8; Washington, DC.
  15. Hall DE, Morrison PK, Nikolajski C, Arnold RM, Fine MJ, Zickmund SL. Informed consent to inguinal herniorrhaphy and cholecystectomy: differences between what surgeons say they discuss and what they actually do discuss. Paper presented at: Academic Surgical Congress; 2013 Feb 7; New Orleans, LA.
  16. Hall DE, Hanusa BH, Fine MJ, Arnold RM. Telling the truth: do the VA’s procedure-specific informed consent documents specify the information actually discussed between surgeons and patients? Poster session presented at: VA HSR&D / QUERI National Meeting; 2012 Jul 17; National Harbor, MD.
  17. Hall DE, Morrison PK, Nikolajski C, Fine MJ, Arnold RM, Zickmund SL. Not just for surgeons any more: iMed Consent as an early tool for informed decision making. Presented at: Association of Veteran Affairs Surgeons Annual Meeting; 2012 Apr 2; Miami Beach, FL.
  18. Hall DE, Hanusa BH, Switzer GE, Fine MJ, Arnold RM. The impact of iMedConsent(TM) on patient decision making among Veterans considering cholecystectomy and inguinal herniorrhaphy. Poster session presented at: VA HSR&D National Meeting; 2011 Feb 17; National Harbor, MD.
  19. Garza MA, Chatman J, Hall DE, Fryer CS, Thomas SB. Examining racial differences in the association of religiousness and trust in research and participation. Presented at: American Public Health Association Annual Meeting and Exposition; 2009 Nov 9; Philadelphia, PA.


DRA: Health Systems, Digestive Diseases
DRE: Treatment - Observational, Research Infrastructure
Keywords: Surgery
MeSH Terms: none

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