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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
200
This is a structured, multi-component continuing care intervention initiated after hospital discharge for colorectal cancer patients with an intestinal stoma. Based on the Response to Transition Theory, it aims to support patients' adaptation during the critical early post-discharge period. The core intervention is a standardized assessment and education session conducted around the third day post-discharge. This is delivered flexibly based on patient location: either an in-home visit by a certified enterostomal therapist via a hospital-approved "Internet + Nursing Service" platform, or a standardized, intensive video follow-up (≥30 minutes) coupled with a mailed stoma care kit for those outside the service area. The intervention is complemented by protocol-driven telephone follow-ups on days 1-2 and at 1 week to reinforce education, provide psychological support, and address individual concerns.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Incidence of stoma and peristomal skin complications
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.
Time frame: From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.
Level of adaptation to the stoma
Measured using the Chinese version of the Ostomy Adjustment Scale (OAS) . The scale consists of 34 items rated on a 6-point Likert scale, with total scores ranging from 34 to 204. A higher total score indicates better psychological and social adaptation to living with a stoma.
Time frame: From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.
Level of stoma-related self-efficacy
Measured using the Chinese version of the Stoma Self-Efficacy Scale (SSES) . This 22-item scale assesses patients' confidence in managing their stoma (stoma efficacy) and in social situations (social self-efficacy) using a 5-point Likert scale. Total scores range from 22 to 110. A higher score indicates greater self-efficacy.
Time frame: 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
Measured using the Chinese version of the Readiness for Hospital Discharge Scale (RHDS) . This 12-item scale assesses a patient's self-perceived preparedness for discharge across three dimensions: personal status, coping ability, and expected support. Each item is scored on a 0-10 scale, with total scores ranging from 0 to 120. A higher total score indicates better readiness for discharge.
Time frame: Assessed at the core intervention point (approximately 3 days post-discharge).
Disease-specific quality of life
Measured using the Chinese version of the Stoma Quality of Life Scale (Stoma-QOL-C) . This 20-item scale evaluates the impact of the stoma on various life domains over the past month across four dimensions (e.g., sleep, social relationships). Each item is scored on a 4-point Likert scale (1 = always, 4 = never), with total scores ranging from 20 to 80. A higher total score indicates better stoma-specific quality of life.
Time frame: 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
Measured using the Chinese version of the Stoma Self-Care Scale - Early Stage version (SSCS-early) . This 10-item scale specifically assesses a patient's skill in independently changing the stoma appliance. Each item is scored on a 5-point Likert scale (1 = very unskilled, 5 = very skilled), with total scores ranging from 10 to 50. A higher score indicates greater self-care ability.
Time frame: 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
Measured as the average length of the index hospital admission in days.
Time frame: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Healthcare Costs
Includes total medical costs during the study period, covering Western and traditional Chinese medicine, stoma center fees, and supplies. Measured in RMB.
Time frame: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Intervention Implementation Costs
The direct costs of implementing the "Flipped Discharge" intervention (e.g., provider travel expenses, personnel time) will be quantified separately. Measured in RMB.
Time frame: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Hospital Readmission Rate
The rate of hospital readmission during the follow-up period. Measured as a percentage (%) .
Time frame: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Patient Trust and Perceived Support
Assessed using a self-developed questionnaire evaluating the nurse-patient relationship. The tool includes two subscales: Trust subscale: Scores range from X to Y, with higher scores indicating greater patient trust in the nurse-patient relationship. Support subscale: Scores range from X to Y, with higher scores indicating greater perceived support from the stoma nurse. Each item is rated on a Likert scale (e.g., 1 = not at all to 5 = completely), and subscale scores are calculated by summing the individual item scores.
Time frame: From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.
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