ClinicalTrials.gg
CompletedNCT07525804Updated Apr 13, 2026

Flipped-Discharge Education for PTCD-Managed Malignant Obstructive Jaundice

An interventional study of Flipped-Discharge Education Model and Routine Discharge Education in Malignant Obstructive Jaundice, sponsored by First People's Hospital of Foshan. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by First People's Hospital of Foshan · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Dec 2023, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malignant Obstructive Jaundice

Browse trials for

Keywords

  • PTCD
  • Percutaneous Transhepatic Cholangiodrainage
  • Flipped-Discharge Education
  • Discharge Readiness
  • Self-Care Capacity
03

In context

Jaundice, Obstructive

62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.

This study's enrollment of 80 is close to the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.

Browse Jaundice, Obstructive studies →

Lead sponsor

First People's Hospital of Foshan is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. Readiness for hospital discharge as assessed by the Readiness for Hospital Discharge Scale (RHDS)-Adult Form

    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.

    Time frame: Approximately 28 days after discharge

Secondary outcomes

  1. Family functioning as assessed by the Family APGAR

    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.

    Time frame: Approximately 28 days after discharge

  2. Self-care agency as assessed by the Exercise of Self-Care Agency Scale (ESCA)

    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.

    Time frame: Approximately 28 days after discharge

  3. Physical health quality of life as assessed by the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF)

    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.

    Time frame: Approximately 28 days after discharge

07

Study locations

1 site
  • Foshan First People's Hospital
    Foshan, Guangdong 528000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07525804
Lead sponsor
First People's Hospital of Foshan
Responsible party
Xia Xiang (Nurse, First People's Hospital of Foshan) — Principal investigator
First posted
Apr 13, 2026
Start date
Dec 1, 2023
Primary completion
Jun 1, 2024
Completion
Jun 1, 2024
Last update
Apr 13, 2026

Study contacts

Xia Xiang, BS
principal investigator · First People's Hospital of Foshan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion