Construction and Empirical Study of a "Flipped" Discharge Model for Colorectal Cancer Patients With Stoma Based on Response Transformation Theory Research
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of stoma and peristomal skin complications
研究概览
简要总结
This multicenter randomized controlled trial aims to develop and evaluate the effectiveness of a "Flipped Discharge" intervention for colorectal cancer patients with a new intestinal stoma. Guided by the Response to Transition Theory, the model addresses the care gap during the vulnerable post-discharge period by shifting critical support from the hospital to the patient's home. Approximately 200 eligible patients will be randomized into either the intervention or standard care control group. The core "Flipped Discharge" intervention occurs on the third day post-discharge, delivered either as an in-home visit by a specialist stoma nurse (via an "Internet + Nursing Service" platform) or as an intensive, standardized video follow-up with mailed instructional materials. The study's primary outcome is the incidence of stoma-related complications. Secondary outcomes include quality of life, self-care ability, self-efficacy, stoma adaptation, discharge readiness, healthcare costs, and satisfaction. The trial will also explore the mechanisms by which the intervention affects patient outcomes, ultimately seeking to provide evidence for a feasible, patient-centered model to improve care continuity.
详细描述
This study aims to develop and test a "Flipped Discharge" model for colorectal cancer patients with an intestinal stoma (ostomy) based on the Response to Transition Theory. After stoma surgery, patients often face significant physical, psychological, and social challenges during the vulnerable early post-discharge period. Current care models, characterized by shorter hospital stays and limited follow-up support, may leave patients unprepared for self-care, potentially leading to complications, reduced quality of life, and increased hospital readmissions. The proposed "Flipped Discharge" model shifts essential post-discharge assessments and education from the hospital to the patient's home or via enhanced remote support, aiming to provide continuous, specialized care during this critical transition. In this multi-center study, approximately 200 eligible patients will be randomly assigned to either an intervention group receiving the "Flipped Discharge" protocol or a control group receiving standard care. The intervention includes early telephone follow-ups and a core intervention around the third day after discharge, delivered either through an in-home visit by a specialized stoma nurse within an established "Internet + Nursing Service" network or a standardized intensive video follow-up with mailed instructional materials for patients outside the service coverage area. The study will measure outcomes including stoma-related complications (primary outcome), patient quality of life, self-care ability, self-efficacy, adaptation to the stoma, readiness for discharge, healthcare costs, and satisfaction. The research also seeks to understand how factors like self-efficacy influence quality of life, with the ultimate goal of determining if this model is effective and feasible in improving care continuity and patient outcomes, thereby providing evidence for a new patient-centered care model suited to the current healthcare context.
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 (Participant)
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
- •Pathologically diagnosed colorectal cancer patients undergoing their first radical surgery with either abdominoperineal resection (Miles) plus permanent colostomy or sphincter-preserving anterior resection (Dixon) plus temporary ileostomy.
- •Aged 18 years or older.
- •Possess at least elementary school education and are able to read, communicate, and understand questionnaire content. Voluntarily participate and provide written informed consent.
- •Postoperative condition is stable without major complications, and patient is conscious.
- •Meets standard hospital discharge criteria with normally functioning stoma.
排除标准
- •History of psychiatric disorders or severe cognitive impairment.
- •Diagnosis with other concurrent malignancies.
研究组 & 干预措施
Flipped Discharge Model Group
Participants receive the "Flipped Discharge" intervention based on Response to Transition Theory. This includes standardized post-discharge telephone follow-ups on days 1-2. The core intervention occurs around day 3 (±1 day), delivered either via an in-home visit by a certified stoma nurse through the hospital's "Internet + Nursing Service" platform or, for eligible patients outside the service area, a standardized intensive video follow-up (≥30 min) with a mailed stoma care kit. Additional telephone support is provided at 1 week. All interventions follow a central protocol and are conducted by trained, certified stoma care specialists.
干预措施: Response to Transition Theory-based Flipped Discharge Model (Behavioral)
Standard Care Group
Participants receive routine post-discharge care and follow-up as per the current standard practice at their respective hospital centers. This typically includes conventional discharge education and scheduled follow-up contacts (e.g., phone calls) conducted by hospital staff according to local protocols, without the structured, early in-home or intensive video intervention provided to the intervention group.
结局指标
主要结局
Incidence of stoma and peristomal skin complications
时间窗: From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.
The occurrence of complications related to the intestinal stoma and the surrounding skin will be assessed using a standardized Stoma Complication Assessment Form. This form evaluates six major items: changes in peristomal skin, degree of stoma prolapse, presence of parastomal hernia, degree of stoma stenosis, degree of stoma retraction, and degree of stoma mucocutaneous separation. Each item has specific criteria and a scoring system, with a higher total score indicating a greater number and severity of complications.
次要结局
- Level of adaptation to the stoma(From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.)
- Length of Hospital Stay(From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).)
- Level of stoma-related self-efficacy(From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.)
- Readiness for hospital discharge(Assessed at the core intervention point (approximately 3 days post-discharge).)
- Disease-specific quality of life(From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.)
- Self-care ability for stoma management(From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.)
- Healthcare Costs(From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).)
- Intervention Implementation Costs(From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).)
- Hospital Readmission Rate(From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).)
- Patient Trust and Perceived Support(From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.)
研究者
Luo BaoJia
Associate chief nurse
Sun Yat-Sen University Cancer Center