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NCT Number: NCT07525804

Flipped-Discharge Education for PTCD-Managed Malignant Obstructive Jaundice

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.

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Key information

Conditions

Malignant Obstructive Jaundice

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foshan First People's Hospital

Foshan, Guangdong, 528000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flipped-Discharge Education Model

Behavioral

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.

Routine Discharge Education

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

First People's Hospital of Foshan

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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