Flipped-Discharge Education for PTCD-Managed Malignant Obstructive Jaundice

NCT07525804 | Completed

• 1 other identifier: gdshsxh2023ms48-PTCD-RCT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Obstructive Jaundice

Keywords

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

Outcome Measures

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.

  Approximately 28 days after discharge

Secondary Outcomes (3)

• Family functioning as assessed by the Family APGAR

  Approximately 28 days after discharge

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

  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)

  Approximately 28 days after discharge

Study Arms (2)

Flipped-Discharge Education

EXPERIMENTAL

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

Routine Education

ACTIVE COMPARATOR

Participants received routine discharge education, including standard written and verbal PTCD catheter care instructions and post-discharge precautions.

Behavioral: Routine Discharge Education

Interventions

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.

Routine Education

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.

Flipped-Discharge Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychiatric disorders
• Active severe infection
• Hematologic disease
• Language barriers
• Anticipated loss to follow-up
• Disease progression, death during the study period, or voluntary withdrawal

Sponsors & Collaborators

• First People's Hospital of Foshan: lead

Study Sites (1)

Foshan First People's Hospital

Foshan, Guangdong, 528000, China

Location

Study Officials

• Xia Xiang, BS

  First People's Hospital of Foshan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the educational nature of the intervention, participants and educators were not blinded. Outcome assessors and data analysts were blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 13, 2026
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)