Flipped-Discharge Education for PTCD-Managed Malignant Obstructive Jaundice

April 7, 2026 updated by: Xia Xiang, First People's Hospital of Foshan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Foshan First People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Flipped-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.
Active Comparator: Routine Education
Participants received routine discharge education, including standard written and verbal PTCD catheter care instructions and post-discharge precautions.
Behavioral: Routine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readiness for hospital discharge as assessed by the Readiness for Hospital Discharge Scale (RHDS)-Adult Form
Time Frame: 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.
Approximately 28 days after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family functioning as assessed by the Family APGAR
Time Frame: 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.
Approximately 28 days after discharge
Self-care agency as assessed by the Exercise of Self-Care Agency Scale (ESCA)
Time Frame: 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.
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)
Time Frame: 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.
Approximately 28 days after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Foshan

Investigators

  • Principal Investigator: Xia Xiang, BS, First People's Hospital of Foshan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • gdshsxh2023ms48-PTCD-RCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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