Clinical trial NCT03988569: Enhanced Consent and Preparedness for Surgery Trial
Official title: Enhanced Consent and Preparedness for Surgery (ECAPS) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Urge Incontinence
Pelvic Organ Prolapse
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the proposed study is to test the null hypothesis that there is no difference in surgical preparedness between women who receive a standard surgical consent for pelvic reconstructive surgery (control) and those who receive a standard surgical consent that is enhanced with an audiovisual decision aid (treatment) for the same surgery. Equivalently, the null hypothesis is that the odds ratio is 1.00.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To develop an audiovisual decision aid (AVDA) to improve the informed consent process. The investigators aim to examine the impact of a comprehensible AVDA that is written below the 8th grade reading level. The AVDA would be used for surgical consent compared to traditional verbal consent. Additionally, the investigators plan to determine whether this effect varies across the measured levels of health literacy of our patients.

Detailed description: To address the limitations of consent, interventions have been developed to improve the quality of information provided to patients including written pamphlets, videos, and websites. Such interventions have been called decision aids. Decision aids may promote informed consent through greater knowledge and consistency of personal values or attitudes with an enacted choice. Providing adequate information increases satisfaction, more rapid symptom resolution, reduced emotional distress, reduced use of analgesia, and possibly shorter hospital admissions. Cochrane reviews have established that audiovisual decision aids enhance informed surgical consent, yet little data exists about the benefits of such aids in Female Pelvic Medicine and Reconstructive Surgery (FPMRS)4.

Eligibility criteria: Inclusion Criteria:

* Patients electing for surgical intervention of pelvic organ prolapse, stress urinary incontinence, urgency urinary incontinence by treating physicians in the Female Pelvic Medicine \& Reconstructive Surgery.

Exclusion Criteria:

* Patients ≤ 18 years old
* Non-English speaking patients
* Patients with video or audio impairments who are unable to view the AVDA

Primary outcomes:
measure: Preparedness for surgery
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola Medical Center
state: Illinois
Study officials:
affiliation: Loyola Medical Center
name: Marian G Acevedo-Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vos IML, Schermer MHN, Bolt ILLE. Recent insights into decision-making and their implications for informed consent. J Med Ethics. 2018 Nov;44(11):734-738. doi: 10.1136/medethics-2018-104884. Epub 2018 Jul 21.
citation: Weiss BD, Blanchard JS, McGee DL, Hart G, Warren B, Burgoon M, Smith KJ. Illiteracy among Medicaid recipients and its relationship to health care costs. J Health Care Poor Underserved. 1994;5(2):99-111. doi: 10.1353/hpu.2010.0272.
citation: Institute of Medicine (US) Committee on Health Literacy; Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: A Prescription to End Confusion. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216032/
citation: Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999 Sep;38(1):33-42. doi: 10.1016/s0738-3991(98)00116-5.