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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Enrolling

Conditions

Prolapse
Incontinence

Treatments

Behavioral: Telehealth intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06679621
300012104
1K23HD115269 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment

357 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

357 participants in 2 patient groups

Routine Preoperative Counseling
No Intervention group
Description:
Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling.
Telehealth intervention
Experimental group
Description:
Patient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention.
Treatment:
Behavioral: Telehealth intervention

Trial contacts and locations

1

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Central trial contact

Gabriela Halder, MD, MPH

Data sourced from clinicaltrials.gov

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