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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00288899
First received: February 6, 2006
Last updated: February 6, 2014
Last verified: June 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Patient comprehension; Patient satisfaction; Patient anxiety; Patient compliance; Provider acceptance [ Time Frame: 45 days ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

Enrollment: 575
Study Start Date: August 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288899

Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
United States, Florida
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States, 33612
United States, Georgia
VA Medical Center, Decatur
Decatur, Georgia, United States, 30033
United States, Massachusetts
VA Boston Healthcare System, Boston
Boston, Massachusetts, United States, 02130
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97239-2964
United States, Pennsylvania
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Aaron S Fink, MD VA Medical Center, Decatur
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00288899     History of Changes
Other Study ID Numbers: IAF 05-308
Study First Received: February 6, 2006
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Informed Consent
Medical Record Systems, computerized
Comprehension
Anxiety
Personal Satisfactin

ClinicalTrials.gov processed this record on July 24, 2014