Malignant Obstructive Jaundice
Conditions
Keywords
PTCD, Percutaneous Transhepatic Cholangiodrainage, Flipped-Discharge Education, Discharge Readiness, Self-Care Capacity
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFlipped-Discharge Education Model
Structured education delivered by a multidisciplinary team, including PTCD catheter-care training, individualized discharge planning, and weekly telehealth follow-up during the first 4 weeks after discharge.
BEHAVIORALRoutine Discharge Education
Standard discharge education delivered by healthcare providers, including self-guided review of health manuals, verbal explanation of PTCD catheter care, and a checklist of post-discharge precautions.
Sponsors
First People's Hospital of Foshan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the educational nature of the intervention, participants and educators were not blinded. Outcome assessors and data analysts were blinded to group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Psychiatric disorders * Active severe infection * Hematologic disease * Language barriers * Anticipated loss to follow-up * Disease progression, death during the study period, or voluntary withdrawal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Readiness for hospital discharge as assessed by the Readiness for Hospital Discharge Scale (RHDS)-Adult Form | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family functioning as assessed by the Family APGAR | Approximately 28 days after discharge | The Family APGAR is a 5-item scale that assesses satisfaction with family functioning. Each item is scored from 0 to 2, and the total score ranges from 0 to 10, with higher scores indicating better family functioning and therefore a better outcome. |
| Self-care agency as assessed by the Exercise of Self-Care Agency Scale (ESCA) | Approximately 28 days after discharge | The Exercise of Self-Care Agency Scale (ESCA) assesses an individual's self-care agency. This 35-item scale is scored on a 5-point Likert scale from 0 to 4 for each item, yielding a total score ranging from 0 to 140. Higher scores indicate greater self-care agency and therefore a better outcome. |
| 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 | The World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) assesses quality of life across four domains. The physical health domain score is calculated using the standard WHOQOL-BREF scoring method. Scores range from 4 to 20, with higher scores indicating better quality of life in the physical health domain. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXia Xiang, BS
First People's Hospital of Foshan
Outcome results
None listed