Three-Dimensional-Printed Models and Shared Decision-Making: A Cluster Randomized Clinical Trial

Abstract

Importance: Patients undergoing surgery report a lack of involvement in health care decisions and increased anxiety. Three-dimensional (3D)-printed models serve as educational tools to encourage patient engagement, reduce anxiety levels, and aid understanding.

Objective: To determine the impact of 3D-printed anatomic models on shared decision-making (SDM) and patient anxiety during the preoperative surgical consultation for colon or rectal resection.

Design, setting, and participants: This single-center cluster randomized clinical trial was conducted from March 2022 to June 2023 at a colorectal surgery clinic at an academic medical institution and included adult patients scheduled for partial or complete colon and/or rectal resection for colorectal cancer, diverticular disease, or inflammatory bowel disease.

Intervention: Six surgeons (clusters) were randomized to counsel patients using a modular 3D-printed model or providing usual care during preoperative clinic visits.

Main outcomes and measures: The primary outcome was the patient's perception of involvement in decision-making using the 9-item Shared Decision Making Questionnaire. The secondary outcome was the change in anxiety level measured using the State-Trait Anxiety Inventory. Patient characteristics were compared between the 3D-printed model and usual care arms using a χ2 test for categorical variables and a t test for comparisons between continuous variables.

Results: Among the 51 patients enrolled (mean [SD] age, 50.7 [14.5] years; 28 female [54.9%]), 28 (54.9%) were in the 3D-printed model arm and 23 (45.1%) were in the usual care arm. Patients counseled with the 3D-printed model reported a significantly higher involvement in SDM compared with those in the usual care group (mean [SD] score, 89.5 [17.6] vs 80.5 [14.4]; P = .01). Additionally, using a 3D-printed model significantly reduced mean anxiety scores (from 53.5 [SD, 21.2] to 44.1 [SD, 15.8]) compared with conventional methods (from 50.4 [SD, 18.3] to 48.0 [SD, 15.3]) (P = .04).

Conclusions and relevance: This cluster randomized clinical trial found that counseling aided with 3D models during preoperative clinic visits improved SDM among patients undergoing colorectal surgery. This study highlights the potential of 3D-printed models as a tool to enhance patient-clinician collaborations. Given the findings, further research into the effectiveness and implementation of these tools is recommended in more diverse clinical settings.

Trial registration: ClinicalTrials.gov Identifier: NCT06625008.

Figure 1.. Study Flow Diagram

3D indicates 3-dimensional; SDM-Q-9, 9-item Shared Decision Making Questionnaire; STAI-6, 6-item State-Trait Anxiety Inventory.

Figure 2.. Three-Dimensional–Printed Model of a Human Torso With a Colon and a Rectum

Photographs show detachable magnetic modules (A), ostomy sites (B), and the relationship of the colon and the rectum to the urinary system in an open (C) and closed (D) version of the model. A indicates appendix; C, cecum; L, left or descending colon; R, right or ascending colon (top left) and rectum (bottom center); S, sigmoid.

Figure 3.. Primary and Secondary Outcomes Comparing the 3-Dimensional (3D)-Printed Model With the Usual Care Model

A, Postvisit shared decision-making scores using the 9-item Shared Decision Making Questionnaire (SDM-Q-9), in which scores ranged from 0 to 100, with higher scores indicating the patient’s perception of greater involvement in their care. B, Baseline and postintervention patient anxiety levels using the 6-item State-Trait Anxiety Inventory (STAI-6), in which scores ranged from 0 to 100, with higher scores indicating a higher state of anxiety. Error bars indicate SDs.