Preoperative 3D Models and Shared Decision-making

Vanderbilt University Medical Center51 enrolled

Overview

The objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.

In this single-center pilot cluster randomized controlled trial, the investigators will prospectively measure patient-reported outcomes on shared decision-making and change in anxiety and knowledge. This study will consist of two arms with at least 20 patients each. Six surgeons will be randomly assigned using the opaque sealed envelope method to counsel patients using a modular 3D-printed model or providing standard care during pre-operative clinic visits. The eligibility criteria for the control and investigational arms will be standardized. The biostatistician will use Student t-tests to compare mean scores and ANCOVA to compare the change in mean scores after the pre-operative clinic visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Shared Decision Making Anxiety Informed Consent

Interventions

3D-printed modelOTHER

The Department of Radiology at Vanderbilt University Medical Center will create a 3D-printed human torso model that includes the colon, rectum, and a stoma on the abdominal wall. This model will be used to provide pre-operative counseling during the surgical consent for patients.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must be \>18 years * Patients scheduled for surgical intervention that would involve partial or complete resection of the colon and/or rectum Exclusion Criteria: * Patients requiring complex surgical reconstruction of organs other than the colon and/or rectum

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Shared decision making

Quantify and compare patient perception of involvement in decision-making in either arm, measured by the validated Shared Decision Making (SDM-Q9) tool.

Time frame: Within 30 minutes after the preoperative counselling session.

Secondary Outcomes

Change in patient anxiety

Quantify and compare patient anxiety levels before and after the pre-operative consent, measured by the validated State-Trait Anxiety Inventory (STAI-6) among the study arms.

Time frame: Within 30 minutes before and 30 minutes after the preoperative counselling session.

Change in patient knowledge using a self-developed questionnaire

Using a self-developed questionnaire to quantify and compare patient knowledge of the essential aspects of anatomy, disease, and surgical procedure covered in preoperative counseling to understand how patient knowledge improves with counseling and compares between the study arms.

Time frame: Within 30 minutes before and 30 minutes after the preoperative counselling session.

Data from ClinicalTrials.gov

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