A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2027-06-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Incontinence Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The randomized design is for Aim 3 of our study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Routine Preoperative Counseling

Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling.

Group Type NO_INTERVENTION

No interventions assigned to this group

Telehealth intervention

Patient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention.

Group Type EXPERIMENTAL

Telehealth intervention

Intervention Type BEHAVIORAL

This telehealth intervention will be made using human centered design methods

Interventions

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Telehealth intervention

This telehealth intervention will be made using human centered design methods

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes