A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 357
- 试验地点
- 1
- 主要终点
- Appropriateness of the Intervention
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 其他
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 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
排除标准
- 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
研究组 & 干预措施
Telehealth intervention
Patient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention.
干预措施: Telehealth intervention (Behavioral)
Routine Preoperative Counseling
Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling.
结局指标
主要结局
Appropriateness of the Intervention
时间窗: Day of Surgery, before surgery, in the preoperative holding
As measured by the Intervention Appropriateness Measure
Feasibility of the Intervention
时间窗: 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
Acceptability of the Intervention
时间窗: Day of Surgery, before surgery, in the preoperative holding
As measured by the Acceptability of the Intervention Measure
次要结局
- Decisional Conflict(Day of Surgery, before surgery, in the preoperative holding)
- Postoperative Anxiety/Depression(Preoperative Visit, before surgery)
- Satisfaction with Healthcare Services(Postoperative Visit 6-8 weeks after surgery)
- Surgical Preparedness(Day of Surgery, before surgery, in the preoperative holding)
- Health Literacy(Preoperative Visit, before surgery)
- Self-Efficacy(Preoperative Visit, before surgery)
- Trust in Provider(Preoperative Visit, before surgery)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06679621
- 其他研究编号
- 300012104, 1K23HD115269
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (8个月后)
- 研究完成日期
- (8个月后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否