Clinical trial NCT00288899: Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
Official title: Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Surgery
Cholecystectomy, Laparoscopic
Prostatectomy
Arthroplasty, Replacement, Hip
Endarterectomy, Carotid
Keywords: Informed Consent
Medical Record Systems, computerized
Comprehension
Anxiety
Personal Satisfactin
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-02-08
Enrollment: 575
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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".

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 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.

Primary outcomes:
measure: Patient comprehension; Patient satisfaction; Patient anxiety; Patient compliance; Provider acceptance
timeFrame: 45 days
Secondary outcomes:
measure: Risk-adjusted surgical outcomes
timeFrame: 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.
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver, CO
state: Colorado
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Aaron S Fink, MD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.