Clinical trial NCT06583577: Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
Official title: 3D Ostomy Simulation for Patient Education
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ostomy
Ileal Conduit
Keywords: Patient education
Simulation
Quality of life
Ostomy adjustment
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to two treatment groups. The experimental group will receive preoperative hands on education on stoma care using a new 3D model. The comparator group will receive standard preoperative education.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate the feasibility of using a realistic and anatomically accurate 3D printed simulation model for urologic bowel diversion patient education. Using a randomized two group design, we aim to determine whether the use of this model enhances patient knowledge, self-care skills, and confidence in ostomy care. We will also evaluate changes in quality of life (QOL) and patient satisfaction comparing patients exposed to the 3D model to those receiving standard of care.

The secondary aim of the study is to examine the differences between groups on patient outcomes including hospital duration, mortality, emergency/urgent health care visits, readmissions, and infections.

Participants will be educated using 3D model simulation as part of their preoperative education (experimental group) or have standard education without using the simulation model (comparator group). Both groups will complete quality of life (QOL), ostomy adjustment, and satisfaction with education surveys during their preoperative education visit and again during their routine follow-up visits (a) within 3 weeks after surgery, (b) between 5- 8 weeks after surgery, and (c) at approximately 3 months after surgery.

Detailed description: Inclusion Criteria:

Age\>18 and planning to undergo bowel diversion urologic surgery.

Exclusion Criteria: Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.

Radom allocation and concealment: During a regularly schedule preoperative clinic visit participants that consent to the study will be asked to complete a short 36 item quality-of-life questionnaire (SF-36). The participant then be placed in either the experimental or comparator group using a random method similar to flipping a coin. Random allocation sequencing will be predetermined by a database specialist, who has no other role in the study. Therefore, all study staff, clinic staff and investigators will be blinded to the allocation sequencing, and will not be able to influence the group participants are assigned to.

Preoperative education: The clinic staff will provide participants with preoperative education according to their group assignment. Participants in the experimental group, will receive standard ostomy education supplemented by use of the simulation model. Those allocated to the comparator group will receive standard preoperative education.

Surveys: During the preoperative visit prior to receiving education, all participants will be asked to complete a quality of life survey, the SF-36. After the education, participants will be asked to complete the Ostomy Adjustment scale (OAS), and a visual analog scale (VAS) indicating their satisfaction with the ostomy education.

During regular postoperative visits within 3 weeks, between 5-8 weeks and approximately 3 months after leaving the hospital, participants will be asked to complete the SF-36, the OAS, and VAS. All study procedures will be conducted at the surgeon's clinic.

Eligibility criteria: Inclusion Criteria:

* Age\>18, undergoing bowel diversion urologic surgery.

Exclusion Criteria:

* Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.

Primary outcomes:
measure: Develop 3D printed model for urologic bowel diversion
timeFrame: Models were created and approved prior to start of the project
measure: Quality of life using SF-36 scale
timeFrame: Preoperatively before education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
measure: Adjustment of Ostomy
timeFrame: Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
measure: Satisfaction with ostomy education
timeFrame: Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
Secondary outcomes:
measure: Post operative hospital duration
timeFrame: Day the patient is deemed ready for hospital discharge, up to 52 weeks
measure: In-hospital mortality
timeFrame: Up to 12 weeks
measure: Unplanned visit to urgent healthcare after discharge from the hospital
timeFrame: Measured at 3 weeks and 3 months
measure: Hospital readmission after discharge from the hospital.
timeFrame: Measured at 3 weeks and 3 months
measure: Surgical site infection
timeFrame: Measured at 3 weeks and 3 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: