Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06679621

A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Incontinence Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama Birmginham

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Gabriela Principal Investigator

CONTACT

[email protected]

205-934-5498

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth Intervention

Behavioral

This telehealth intervention will be made using human centered design methods

Primary outcomes

  1. Feasibility of the Intervention

    Time frame: 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

  2. Acceptability of the Intervention

    Time frame: Day of Surgery, before surgery, in the preoperative holding

    As measured by the Acceptability of the Intervention Measure

  3. Appropriateness of the Intervention

    Time frame: Day of Surgery, before surgery, in the preoperative holding

    As measured by the Intervention Appropriateness Measure

Secondary outcomes

  1. Surgical Preparedness

    Time frame: Day of Surgery, before surgery, in the preoperative holding

    As measured by the Surgical Preparedness Assessment survey

  2. Health Literacy

    Time frame: Preoperative Visit, before surgery

    As measured by the Brief Health Literacy Screen

  3. Self-Efficacy

    Time frame: Preoperative Visit, before surgery

    As measured by the General Self-Efficacy Scale

  4. Trust in Provider

    Time frame: Preoperative Visit, before surgery

    As measured by the Trust in Provider Scale

  5. Decisional Conflict

    Time frame: Day of Surgery, before surgery, in the preoperative holding

    As measured by the Decisional Conflict Scale

  6. Postoperative Anxiety/Depression

    Time frame: Preoperative Visit, before surgery

    As measured by the Hospital Anxiety/Depression Scale

  7. Satisfaction with Healthcare Services

    Time frame: Postoperative Visit 6-8 weeks after surgery

    As measured by the CAHPS Clinician & Group Visit Adult Survey

Other outcomes

  1. Demographics

    Time frame: Preoperative Visit 6-8 weeks after surgery

    Baseline Case Report Form

  2. Surgical Data

    Time frame: Day of Surgery, before surgery, in the preoperative holding

    Surgical Case Report Form

  3. Adverse Events

    Time frame: Postoperative Visit 6-8 weeks after surgery

    Adverse Events Case Report Form

  4. Symptom Bother - PFDI 20

    Time frame: Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery

    As measured by the Pelvic Floor Distress Inventory-20

  5. Symptom Bother - PGI-S

    Time frame: Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery

    As measured by the Global Impressions of Severity

  6. General Health

    Time frame: Preoperative Visit, before surgery and Postoperative Visit 6-8 after surgery

    EQ-5D-5L

  7. Self-Esteem

    Time frame: Preoperative Visit, before surgery

    Rosenberg Self-Esteem Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Halder, MD, MPH

CONTACT

[email protected]

205-934-5498

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: TIPPS-Urogyn

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2024
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.