A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telehealth intervention.
- Who it may be relevant to
- Registry conditions: Incontinence, Prolapse. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Behavioral Telehealth intervention
This telehealth intervention will be made using human centered design methods
Primary outcome measures
- Feasibility of the Intervention [Time frame: Day of Surgery, before surgery, in the preoperative holding]
- Acceptability of the Intervention [Time frame: Day of Surgery, before surgery, in the preoperative holding]
- Appropriateness of the Intervention [Time frame: Day of Surgery, before surgery, in the preoperative holding]
Secondary outcome measures (7)
- Surgical Preparedness [Time frame: Day of Surgery, before surgery, in the preoperative holding]
- Health Literacy [Time frame: Preoperative Visit, before surgery]
- Self-Efficacy [Time frame: Preoperative Visit, before surgery]
- Trust in Provider [Time frame: Preoperative Visit, before surgery]
- Decisional Conflict [Time frame: Day of Surgery, before surgery, in the preoperative holding]
- Postoperative Anxiety/Depression [Time frame: Preoperative Visit, before surgery]
- Satisfaction with Healthcare Services [Time frame: Postoperative Visit 6-8 weeks after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Alabama Birmginham — Birmingham
Identifiers
NCT: NCT06679621 · 300012104 · 1K23HD115269