NCT00288899

Brief Summary

This is a VA Merit Review Study involving 7 VA medical centers participating in a parallel group randomized trial comparing "repeat back" versus standard electronic consent for 4 common elective surgical procedures (total hip arthroplasty, carotid endarterectomy, laparoscopic cholecystectomy, and radical prostatectomy). Baseline covariates include health status (SF-12), reading ability (REALM), and demographics. Primary outcomes are patient comprehension of the informed consent, patient satisfaction with the informed consent and decision making processes, patient satisfaction with care, anxiety (STAI), and provider assessment of the "repeat back" process. In addition, we are electronically capturing data detailing time spent in each phase of the consent process including "repeat back".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
575

participants targeted

Target at P75+ for phase_1 surgery

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_1 surgery

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

August 7, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2009

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

2.6 years

First QC Date

February 6, 2006

Last Update Submit

June 2, 2017

Conditions

SurgeryCholecystectomy, LaparoscopicProstatectomyArthroplasty, Replacement, HipEndarterectomy, Carotid

Keywords

Informed ConsentMedical Record Systems, computerizedComprehensionAnxietyPersonal Satisfactin

Outcome Measures

Primary Outcomes (1)

  • Patient comprehension; Patient satisfaction; Patient anxiety; Patient compliance; Provider acceptance

    45 days

Secondary Outcomes (1)

  • Risk-adjusted surgical outcomes

    Surgical outcome data is collected by VA NSQIP program within 45 days of each surgical procedure. This data will be linked with study data at end of study enrollment, during the data analysis phase.

Study Arms (2)

Arm 1

OTHER

standard VA surgical iMedConsent process

Other: standard surgical iMedConsent process

Arm 2

EXPERIMENTAL

enhanced version of VA surgical iMedConsent process (repeat-back)

Other: Enhanced surgical iMedConsent process (with "repeat back")

Interventions

Enhanced surgical iMedConsent process (with "repeat back")OTHER

Consent process engages patient in discussion about why they are having procedure, risks, benefits, alternatives. Then provider asks patient to "repeat back"what they understand.

Arm 2
standard surgical iMedConsent processOTHER

Patients are consented in standard VA consent process, where are not necessarily asked to repeat back and no discussion is necessarily documented.

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans who are scheduled for one of the four elective surgical procedures;
  • who give informed consent to participate in the study;
  • and who are also part of the NSQIP.

You may not qualify if:

  • Inability to give informed consent;
  • requirement for surrogate consent;
  • non-elective surgery;
  • requirement for more than one elective surgery;
  • refusal to participate;
  • inability to communicate in English;
  • severe visual problems;
  • severe psychiatric illness;
  • ongoing substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (9)

  • Kaafarani HM, Itani KM. Classification versus valuation and grading of surgical complications. J Am Coll Surg. 2009 Aug;209(2):290-1; author reply 291-2. doi: 10.1016/j.jamcollsurg.2009.05.020. No abstract available.

    PMID: 19632618RESULT

  • Itani KM. Let us not forget the Association of VA Surgeons (AVAS). Surgery. 2009 Sep;146(3):525; author reply 525-6. doi: 10.1016/j.surg.2008.11.013. No abstract available.

    PMID: 19715815RESULT

  • Itani KM, Kim L. Mechanical bowel preparation or not for elective colorectal surgery. Surg Infect (Larchmt). 2008 Dec;9(6):563-5. doi: 10.1089/sur.2008.9957.

    PMID: 19216667RESULT

  • Itani KM, Akhras KS, Stellhorn R, Quintana A, Budd D, Merchant S. Outcomes associated with initial versus later vancomycin use in patients with complicated skin and skin-structure infections. Pharmacoeconomics. 2009;27(5):421-30. doi: 10.2165/00019053-200927050-00006.

    PMID: 19586079RESULT

  • 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. Predictors of comprehension during surgical informed consent. J Am Coll Surg. 2010 Jun;210(6):919-26. doi: 10.1016/j.jamcollsurg.2010.02.049.

    PMID: 20510800RESULT

  • 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. Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial. Ann Surg. 2010 Jul;252(1):27-36. doi: 10.1097/SLA.0b013e3181e3ec61.

    PMID: 20562609RESULT

  • Rosen AK, Loveland SA, Romano PS, Itani KM, Silber JH, Even-Shoshan OO, Halenar MJ, Teng Y, Zhu J, Volpp KG. Effects of resident duty hour reform on surgical and procedural patient safety indicators among hospitalized Veterans Health Administration and Medicare patients. Med Care. 2009 Jul;47(7):723-31. doi: 10.1097/MLR.0b013e31819a588f.

    PMID: 19536029RESULT

  • Volpp KG, Rosen AK, Rosenbaum PR, Romano PS, Itani KM, Bellini L, Even-Shoshan O, Cen L, Wang Y, Halenar MJ, Silber JH. Did duty hour reform lead to better outcomes among the highest risk patients? J Gen Intern Med. 2009 Oct;24(10):1149-55. doi: 10.1007/s11606-009-1011-z. Epub 2009 May 20.

    PMID: 19455368RESULT

  • Prochazka AV, Fink AS, Bartenfeld D, Henderson WG, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Patient perceptions of surgical informed consent: is repeat back helpful or harmful? J Patient Saf. 2014 Sep;10(3):140-5. doi: 10.1097/PTS.0b013e3182a00317.

    PMID: 24522223DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Aaron S Fink, MD

    Atlanta VA Medical and Rehab Center, Decatur, GA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 8, 2006

Study Start

August 7, 2006

Primary Completion

March 31, 2009

Study Completion

March 31, 2009

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

US(7)