Surgery Clinical Trial
Official title:
Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
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".
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.
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