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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HD115269 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Preoperative Counseling | No Intervention | Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling. | |
| Telehealth intervention | Experimental | Patient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth intervention | Behavioral | This telehealth intervention will be made using human centered design methods |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Intervention | 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 | Day of Surgery, before surgery, in the preoperative holding |
| Acceptability of the Intervention | As measured by the Acceptability of the Intervention Measure | Day of Surgery, before surgery, in the preoperative holding |
| Appropriateness of the Intervention | As measured by the Intervention Appropriateness Measure | Day of Surgery, before surgery, in the preoperative holding |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Preparedness | As measured by the Surgical Preparedness Assessment survey | Day of Surgery, before surgery, in the preoperative holding |
| Health Literacy | As measured by the Brief Health Literacy Screen |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | Baseline Case Report Form | Preoperative Visit 6-8 weeks after surgery |
| Surgical Data | Surgical Case Report Form | Day of Surgery, before surgery, in the preoperative holding |
Inclusion Criteria:
Patients who
Urogynecologists who -Routinely perform urogynecologist surgeries to correct pelvic organ prolapse, urinary/fecal incontinence, fistula, urethral masses
Nurses who
Exclusion Criteria:
Patients who
Urogynecologists who
-Do not routinely perform urogynecologic surgery
Nurses who
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Halder, MD, MPH | Contact | 205-934-5498 | gehalder@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gabriela Halder, MD, MPH | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmginham | Recruiting | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The randomized design is for Aim 3 of our study.
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| Preoperative Visit, before surgery |
| Self-Efficacy | As measured by the General Self-Efficacy Scale | Preoperative Visit, before surgery |
| Trust in Provider | As measured by the Trust in Provider Scale | Preoperative Visit, before surgery |
| Decisional Conflict | As measured by the Decisional Conflict Scale | Day of Surgery, before surgery, in the preoperative holding |
| Postoperative Anxiety/Depression | As measured by the Hospital Anxiety/Depression Scale | Preoperative Visit, before surgery |
| Satisfaction with Healthcare Services | As measured by the CAHPS Clinician & Group Visit Adult Survey | Postoperative Visit 6-8 weeks after surgery |
| Adverse Events | Adverse Events Case Report Form | Postoperative Visit 6-8 weeks after surgery |
| Symptom Bother - PFDI 20 | As measured by the Pelvic Floor Distress Inventory-20 | Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery |
| Symptom Bother - PGI-S | As measured by the Global Impressions of Severity | Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery |
| General Health | EQ-5D-5L | Preoperative Visit, before surgery and Postoperative Visit 6-8 after surgery |
| Self-Esteem | Rosenberg Self-Esteem Scale | Preoperative Visit, before surgery |