A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas

Not Applicable

Recruiting

• Conditions: Incontinence; Prolapse

• Registration Number: NCT06679621
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

There are 3 aims of this study. In Aim 1 community patient partners will be enrolled to help guide the research being performed in all of the aims. Investigators will also administer a survey that will help determine factors associated with surgical preparedness. In Aim 2 investigators will develop an intervention to increase surgical preparedness using Human Centered Design Methods. Aim 3 will pilot test the intervention using mixed methods to determine feasibility and implementation outcomes.

Detailed Description

The purpose of this project is to understand surgical preparedness in Latinas undergoing urogynecologic surgery and to develop TIPPS-Latina a refined version of our telehealth intervention for Latinas undergoing urogynecologic surgery using HCD and D\&I methods. The goal of the first aim is to develop a participatory design approach and understand surgical preparedness in Latinas undergoing urogynecologic surgery. This cross-sectional study will run in parallel to the other aims. The participatory action framework will guide Aims 1-3. The goals of Aim 2 and Aim 3 are develop and test TIPPS-Latina using the Discover, Design/Build, and Test (DDBT) framework, which is a HCD method to generate evidence-based interventions and their implementations9. During the Discover phase investigators will identify preferences for refinement of TIPPS-Latina and its contextual deployment using mixed methods. During the Design/Build phase investigators will use an iterative process to generate, modify, and adapt our intervention. During the Test phase investigators will conduct pilot testing of TIPPS-Latina using a mixed methods approach that determines feasibility and implementation outcomes. Throughout our study, surgical preparedness will be measured using the Surgical Preparedness Assessment (SPA), a validated survey for measuring preparedness in women undergoing urogynecologic surgery that was developed by our group

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-07
• Study Start: 2024-11-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 357

Inclusion Criteria

Patients who

• Self-report as female
• 18 years and older
• Self-report as Hispanic ethnicity
• Scheduled to undergo a surgery for a urogynecologic condition in the operating room (surgery to correct pelvic organ prolapse, urinary/fecal incontinence, fistula, urethral masses)
• Able to read and write English and/or Spanish

Urogynecologists who -Routinely perform urogynecologist surgeries to correct pelvic organ prolapse, urinary/fecal incontinence, fistula, urethral masses

Nurses who

• Spend most of their time at a urogynecologic clinic
• Engage in the process of preparing patients for urogynecologic surgery

Exclusion Criteria

Patients who

• Self-report as male
• Are less than 18 years of age
• Self-report as not of Hispanic ethnicity
• Scheduled to undergo a surgery for a condition that is not urogynecologic or is not in the operating room
• Patients undergoing procedures that are traditionally performed in the office (bladder Botox, pelvic floor Botox, urethral bulking)

Urogynecologists who

-Do not routinely perform urogynecologic surgery

Nurses who

• Do not spend most of their time at a urogynecology clinic
• Do not engage in the process of preparing patients for urogynecologic surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of the Intervention	Day of Surgery, before surgery, in the preoperative holding	A feasible study will be defined a 1) \>4 on 1-5 Likert-type scales of acceptability, appropriateness, and feasibility; 2) \>70% for adherence; and 3)\> 90% for dose delivery, and percent completed intervention.; Acceptability will be measured by the Acceptability of the Intervention Measure Appropriateness will be measured by the Intervention Appropriateness Measure Feasibility will be measured by the Feasibility of Intervention Measure
Acceptability of the Intervention	Day of Surgery, before surgery, in the preoperative holding	As measured by the Acceptability of the Intervention Measure
Appropriateness of the Intervention	Day of Surgery, before surgery, in the preoperative holding	As measured by the Intervention Appropriateness Measure

Secondary Outcome Measures

Name	Time	Method
Postoperative Anxiety/Depression	Preoperative Visit, before surgery	As measured by the Hospital Anxiety/Depression Scale
Decisional Conflict	Day of Surgery, before surgery, in the preoperative holding	As measured by the Decisional Conflict Scale
Surgical Preparedness	Day of Surgery, before surgery, in the preoperative holding	As measured by the Surgical Preparedness Assessment survey
Health Literacy	Preoperative Visit, before surgery	As measured by the Brief Health Literacy Screen
Self-Efficacy	Preoperative Visit, before surgery	As measured by the General Self-Efficacy Scale
Trust in Provider	Preoperative Visit, before surgery	As measured by the Trust in Provider Scale
Satisfaction with Healthcare Services	Postoperative Visit 6-8 weeks after surgery	As measured by the CAHPS Clinician \& Group Visit Adult Survey

Trial Locations

Locations (1)

University of Alabama Birmginham; 🇺🇸 Birmingham, Alabama, United States