Impact of a Flipped-Discharge Education Model on Therapeutic Outcomes, Self-Care Capacity, and Quality of Life in PTCD-Managed Malignant Obstructive Jaundice: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Readiness for hospital discharge as assessed by the Readiness for Hospital Discharge Scale (RHDS)-Adult Form
研究概览
简要总结
This single-center randomized controlled trial evaluated whether a structured flipped-discharge education model improves discharge readiness and short-term outcomes compared with routine discharge education in adults with malignant obstructive jaundice managed with percutaneous transhepatic cholangiodrainage (PTCD). Participants were randomized 1:1 to flipped-discharge education or routine education and followed for approximately 28 days after discharge.
详细描述
Adults with malignant obstructive jaundice undergoing PTCD at Foshan First People's Hospital were assigned in a 1:1 ratio to a structured flipped-discharge education intervention or routine discharge education. The flipped-discharge model included staged education beginning before discharge, individualized nursing planning, competency-focused catheter-care teaching, and weekly telephone or video follow-up during the first 4 weeks after discharge. The comparator group received routine health education, including standard written and verbal PTCD catheter care instructions and discharge precautions. The primary endpoint was readiness for hospital discharge assessed around Day 28. Secondary endpoints included family function, self-care capacity, quality of life, laboratory markers, and catheter-related complications during 1-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the educational nature of the intervention, participants and educators were not blinded. Outcome assessors and data analysts were blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Diagnosed with malignant obstructive jaundice
- •Undergoing percutaneous transhepatic cholangiodrainage (PTCD)
- •Clear indication for PTCD, such as unresectable biliary obstruction
- •Preserved consciousness and ability to communicate
- •Provided written informed consent
排除标准
- •Psychiatric disorders
- •Active severe infection
- •Hematologic disease
- •Language barriers
- •Anticipated loss to follow-up
- •Disease progression, death during the study period, or voluntary withdrawal
研究组 & 干预措施
Flipped-Discharge Education
Participants received a structured flipped-discharge education program, including staged pre-discharge training, individualized nursing planning, and weekly telehealth follow-up during the first 4 weeks after discharge.
干预措施: Flipped-Discharge Education Model (Behavioral)
Routine Education
Participants received routine discharge education, including standard written and verbal PTCD catheter care instructions and post-discharge precautions.
干预措施: Routine Discharge Education (Behavioral)
结局指标
主要结局
Readiness for hospital discharge as assessed by the Readiness for Hospital Discharge Scale (RHDS)-Adult Form
时间窗: Approximately 28 days after discharge
The Readiness for Hospital Discharge Scale (RHDS)-Adult Form measures patient readiness to return home following acute care hospitalization. According to the scale developer, the RHDS score is calculated by adding the item scores and dividing by the number of items to obtain a mean item score. Possible scores range from 0 to 10, with higher scores indicating greater readiness for hospital discharge and therefore a better outcome.
次要结局
- Family functioning as assessed by the Family APGAR(Approximately 28 days after discharge)
- Self-care agency as assessed by the Exercise of Self-Care Agency Scale (ESCA)(Approximately 28 days after discharge)
- Physical health quality of life as assessed by the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF)(Approximately 28 days after discharge)
研究者
Xia Xiang
Nurse
First People's Hospital of Foshan