Clinical trial NCT06679621: A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas
Official title: A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incontinence
Prolapse
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-11-07
Enrollment: 357
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomized design is for Aim 3 of our study.
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: Day of Surgery, before surgery, in the preoperative holding
measure: Acceptability of the Intervention
timeFrame: Day of Surgery, before surgery, in the preoperative holding
measure: Appropriateness of the Intervention
timeFrame: Day of Surgery, before surgery, in the preoperative holding
Secondary outcomes:
measure: Surgical Preparedness
timeFrame: Day of Surgery, before surgery, in the preoperative holding
measure: Health Literacy
timeFrame: Preoperative Visit, before surgery
measure: Self-Efficacy
timeFrame: Preoperative Visit, before surgery
measure: Trust in Provider
timeFrame: Preoperative Visit, before surgery
measure: Decisional Conflict
timeFrame: Day of Surgery, before surgery, in the preoperative holding
measure: Postoperative Anxiety/Depression
timeFrame: Preoperative Visit, before surgery
measure: Satisfaction with Healthcare Services
timeFrame: Postoperative Visit 6-8 weeks after surgery
Other outcomes:
measure: Demographics
timeFrame: Preoperative Visit 6-8 weeks after surgery
measure: Surgical Data
timeFrame: Day of Surgery, before surgery, in the preoperative holding
measure: Adverse Events
timeFrame: Postoperative Visit 6-8 weeks after surgery
measure: Symptom Bother - PFDI 20
timeFrame: Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery
measure: Symptom Bother - PGI-S
timeFrame: Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery
measure: General Health
timeFrame: Preoperative Visit, before surgery and Postoperative Visit 6-8 after surgery
measure: Self-Esteem
timeFrame: Preoperative Visit, before surgery
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmginham
state: Alabama
Study officials:
affiliation: Assistant Professor
name: Gabriela Halder, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: