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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery, Cholecystectomy, Laparoscopic, Prostatectomy, Arthroplasty, Replacement, Hip, Endarterectomy, Carotid

Intervention / Treatment
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* Other: Enhanced surgical iMedConsent process (with repeat back)
* Other: standard surgical iMedConsent process


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>standard VA surgical iMedConsent process | Other: standard surgical iMedConsent process<br>* Patients are consented in standard VA consent process, where are not necessarily asked to repeat back and no discussion is necessarily documented.<br>|
| Experimental: Arm 2<br>enhanced version of VA surgical iMedConsent process (repeat-back) | Other: Enhanced surgical iMedConsent process (with repeat back)<br>* Consent process engages patient in discussion about why they are having procedure, risks, benefits, alternatives. Then provider asks patient to repeat backwhat they understand.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comprehension; Patient satisfaction; Patient anxiety; Patient compliance; Provider acceptance |  | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk-adjusted surgical outcomes |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Informed Consent, Medical Record Systems, computerized, Comprehension, Anxiety, Personal Satisfactin