Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program

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ClinicalTrials.gov Identifier: NCT00288899

Recruitment Status : Completed

First Posted : February 8, 2006

Last Update Posted : June 6, 2017

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

Study Description

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".

Condition or disease	Intervention/treatment	Phase
Surgery Cholecystectomy, Laparoscopic Prostatectomy Arthroplasty, Replacement, Hip Endarterectomy, Carotid	Other: Enhanced surgical iMedConsent process (with "repeat back") Other: standard surgical iMedConsent process	Phase 1

Detailed Description:

Background: Informed consent for surgical procedures is critical to patient care in the VA and in other health care settings. Many studies document limitations in current methods of obtaining informed consent. These limitations include poor patient comprehension, inadequate time for discussion, poor documentation of consent, and heightening of patient anxiety regarding surgery. In hopes of addressing these shortcomings, both the NQF and AHRQ have recommended that "repeat back" protocols be added to informed consent methodologies. The VA has opted to address the informed consent issue by computerization of the informed consent process utilizing the iMedConsent program. This latter program is fully integrated with the computerized patient record system (CPRS), includes extensive patient education materials, standardizes risk information and guides the clinician through the consent process. The iMedConsent program is being disseminated via an ongoing national rollout. Despite its apparent advantages, the current iMedConsent platform does not incorporate any methodology to support "repeat back". Dialog Medical, the iMedConsent vendor, has recently developed a new module that can enhance the current version of the program by supporting "repeat back" protocols.

Objectives: We hypothesize that use of the enhanced iMedConsent program (with "repeat back") will improve the surgical patient's comprehension about the surgical technique, treatment alternatives, and risks and benefits of the proposed surgery in comparison with the standard iMedConsent program. We believe that this enhanced program will also lead to better patient satisfaction with the consent process, decision making and the health care received, less anxiety about the operation, and that this program will be acceptable to surgical providers and might lead to better clinical outcomes.

Methods: To address these hypotheses we are conducting a multi-site (7 VA Medical Centers) randomized trial comparing the use of the "standard" and "enhanced" iMedConsent program. We will enroll 600 subjects who are scheduled for elective surgery. Subjects will be individually randomized to the standard or enhanced versions of the iMedConsent program. The surgical procedures to be studied include carotid endarterectomy, total hip arthroplasty, radical prostatectomy and laparoscopic cholecystectomy. The study will be linked to the National Surgical Quality Improvement Program data which will provide baseline data on patient characteristics, intraoperative variables (e.g. operation type, time, anesthesia method, etc.), and the data on 30 day surgical outcomes. We will assess endpoints including patient comprehension, patient satisfaction with the consent process, patient anxiety, providers' acceptance of the informed consent process, and patient satisfaction with health care and with decision making using validated self-report survey instruments.

Findings: We are currently in the final phase of data analysis. The final study report will be submitted within the next several weeks to HSR&D.

Status: Study recruitment and enrollment began in August 2006 and ended June 30, 2008. 575 study subjects were randomized, with 502 study subjects completing the study. 214 surgical providers participated and 192 completed provider questionnaires. We continue with final data analysis phase of the study. Manuscripts are being written, with final HSR&D report due within the next several weeks.

Impact: The results of this study will have important implications for improving the consent process within the VA and beyond.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	575 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Health Services Research
Official Title:	Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
Actual Study Start Date :	August 7, 2006
Actual Primary Completion Date :	March 31, 2009
Actual Study Completion Date :	March 31, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Arm 1 standard VA surgical iMedConsent process	Other: standard surgical iMedConsent process Patients are consented in standard VA consent process, where are not necessarily asked to repeat back and no discussion is necessarily documented.
Experimental: Arm 2 enhanced version of VA surgical iMedConsent process (repeat-back)	Other: Enhanced surgical iMedConsent process (with "repeat back") 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.

Outcome Measures

Primary Outcome Measures :

Patient comprehension; Patient satisfaction; Patient anxiety; Patient compliance; Provider acceptance [ Time Frame: 45 days ]

Secondary Outcome Measures :

Risk-adjusted surgical outcomes [ Time Frame: 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288899

Locations


United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030

Sponsors and Collaborators

VA Office of Research and Development

Investigators


Principal Investigator:	Aaron S Fink, MD	Atlanta VA Medical and Rehab Center, Decatur, GA

More Information

Publications of Results:

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.

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.

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00288899 History of Changes
Other Study ID Numbers:	IAF 05-308
First Posted:	February 8, 2006 Key Record Dates
Last Update Posted:	June 6, 2017
Last Verified:	June 2017

Keywords provided by VA Office of Research and Development:


Informed Consent Medical Record Systems, computerized Comprehension Anxiety Personal Satisfactin

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