A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas (TIPPS-Urogyn)

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.

Study Overview

• Status: Recruiting
• Conditions: Prolapse; Incontinence
• Intervention / Treatment: Behavioral: Telehealth intervention

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 Type: Interventional
• Enrollment (Estimated): 357
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriela Halder, MD, MPH; Phone Number: 205-934-5498; Email: gehalder@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama Birmginham
      • Contact: Gabriela Principal Investigator; Phone Number: 205-934-5498; Email: gehalder@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Preoperative Counseling; Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling.
Experimental: Telehealth intervention; Patient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention.	Behavioral: Telehealth intervention; This telehealth intervention will be made using human centered design methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Intervention	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	Day of Surgery, before surgery, in the preoperative holding
Acceptability of the Intervention	As measured by the Acceptability of the Intervention Measure	Day of Surgery, before surgery, in the preoperative holding
Appropriateness of the Intervention	As measured by the Intervention Appropriateness Measure	Day of Surgery, before surgery, in the preoperative holding

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Baseline Case Report Form	Preoperative Visit 6-8 weeks after surgery
Surgical Data	Surgical Case Report Form	Day of Surgery, before surgery, in the preoperative holding
Adverse Events	Adverse Events Case Report Form	Postoperative Visit 6-8 weeks after surgery
General Health	EQ-5D-5L	Preoperative Visit, before surgery and Postoperative Visit 6-8 after surgery
Self-Esteem	Rosenberg Self-Esteem Scale	Preoperative Visit, before surgery
Symptom Bother - PFDI 20	As measured by the Pelvic Floor Distress Inventory-20	Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery
Symptom Bother - PGI-S	As measured by the Global Impressions of Severity	Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Gabriela Halder, MD, MPH, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Prolapse
• Other Study ID Numbers: 300012104; 1K23HD115269 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No