Incontinence, Prolapse
Conditions
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
Interventions
BEHAVIORALTelehealth intervention
This telehealth intervention will be made using human centered design methods
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The randomized design is for Aim 3 of our study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention | 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 |
| Appropriateness of the Intervention | Day of Surgery, before surgery, in the preoperative holding | As measured by the Intervention Appropriateness Measure |
| Acceptability of the Intervention | Day of Surgery, before surgery, in the preoperative holding | As measured by the Acceptability of the Intervention Measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Literacy | Preoperative Visit, before surgery | As measured by the Brief Health Literacy Screen |
| Surgical Preparedness | Day of Surgery, before surgery, in the preoperative holding | As measured by the Surgical Preparedness Assessment survey |
| Self-Efficacy | Preoperative Visit, before surgery | As measured by the General Self-Efficacy Scale |
| Trust in Provider | Preoperative Visit, before surgery | As measured by the Trust in Provider Scale |
| Decisional Conflict | Day of Surgery, before surgery, in the preoperative holding | As measured by the Decisional Conflict Scale |
| Postoperative Anxiety/Depression | Preoperative Visit, before surgery | As measured by the Hospital Anxiety/Depression Scale |
| Satisfaction with Healthcare Services | Postoperative Visit 6-8 weeks after surgery | As measured by the CAHPS Clinician & Group Visit Adult Survey |
Other
| Measure | Time frame | Description |
|---|---|---|
| Surgical Data | Day of Surgery, before surgery, in the preoperative holding | Surgical Case Report Form |
| Symptom Bother - PGI-S | Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery | As measured by the Global Impressions of Severity |
| General Health | Preoperative Visit, before surgery and Postoperative Visit 6-8 after surgery | EQ-5D-5L |
| Self-Esteem | Preoperative Visit, before surgery | Rosenberg Self-Esteem Scale |
| Symptom Bother - PFDI 20 | Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery | As measured by the Pelvic Floor Distress Inventory-20 |
| Demographics | Preoperative Visit 6-8 weeks after surgery | Baseline Case Report Form |
| Adverse Events | Postoperative Visit 6-8 weeks after surgery | Adverse Events Case Report Form |
Countries
United States
Contacts
Primary ContactGabriela Halder, MD, MPH
Outcome results
None listed