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BACKGROUND/RATIONALE:
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.
OBJECTIVE(S):
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/RESULTS:
Starting in February 2006, we developed study operations manual, worked on changes to the enhanced (repeat-back) module of iMedConsent program, finished developing and pilot testing our study questionnaires, had all 7 study sites obtain local IRB & R&D approval and sites began hiring study coordinators. We had our initial Steering &DSMB committee mtgs. in 5/06, and our start-up mtg. in 6/06 to train all study team members on the conduct of the study. In 7/06, workflow assessments of all site surgical clinics done and critical risks determined for each of study procedures. Study recruitment and enrollment began at 3 sites 8/06, one started in 9/06 and another at the end of 10/06. The last 2 sites have very recently hired study coordinators so are set to begin recruitment activity. To date, we have randomized 82 patients, across 5 sites, with 35 patients completing the study. 57 providers have been enrolled and feedback obtained from 14. Data entry and analysis are in preliminary stages, with first progress report due for completion by 3/07 for Steering Commitee and DSMB Commitee conference calls.
IMPACT:
The results of this study will have important implications for improving the consent process within the VA and beyond.
PUBLICATIONS:
None at this time.
DRA:
Health Services and Systems
DRE:
Technology Development and Assessment, Communication and Decision Making, Quality of Care
Keywords:
Surgery
MeSH Terms:
Informed Consent
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