Surgery Clinical Trial
Official title:
Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
Verified date | June 2017 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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".
Status | Completed |
Enrollment | 575 |
Est. completion date | March 31, 2009 |
Est. primary completion date | March 31, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts |
United States | Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia |
United States | VA Eastern Colorado Health Care System, Denver, CO | Denver | Colorado |
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
United States | VA Portland Health Care System, Portland, OR | Portland | Oregon |
United States | James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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 controll — View Citation
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. d — View Citation
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: 10.2165/00019053-200 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 Me — View Citation
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/s — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient comprehension; Patient satisfaction; Patient anxiety; Patient compliance; Provider acceptance | 45 days | ||
Secondary | 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. |
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