Malignant Obstructive JaundiceNCT07525804
Flipped-Discharge Education for PTCD-Managed Malignant Obstructive Jaundice
A study testing Flipped-Discharge Education Model and Routine Discharge Education in people with Malignant Obstructive Jaundice, run by First People's Hospital of Foshan at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Obstructive Jaundice
- What is being tested?
- Flipped-Discharge Education Model and Routine Discharge Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychiatric disorders
- Active severe infection
- Hematologic disease
- Language barriers
- Anticipated loss to follow-up
- Disease progression, death during the study period, or voluntary withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Malignant Obstructive Jaundice
- Being tested
- Flipped-Discharge Education Model, Routine Discharge Education
- Keywords
- PTCD, Percutaneous Transhepatic Cholangiodrainage, Flipped-Discharge Education, Discharge Readiness, Self-Care Capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flipped-Discharge Education ModelBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Routine Discharge Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 28 days after discharge
Secondary outcomes (3)
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.
Measured: Approximately 28 days after discharge
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.
Measured: 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)
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.
Measured: Approximately 28 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Dec 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Obstructive JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Xiang, First People's Hospital of Foshan
- Investigators
- Xia Xiang, BS, Principal investigator, First People's Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525804
- Sponsor's protocol ID
- gdshsxh2023ms48-PTCD-RCT
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07525804
- Acronym / sponsor ID
- gdshsxh2023ms48-PTCD-RCT
- Conditions
- Malignant Obstructive Jaundice
- Keywords
- PTCD, Percutaneous Transhepatic Cholangiodrainage, Flipped-Discharge Education, Discharge Readiness, Self-Care Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- First People's Hospital of FoshanUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flipped-Discharge Education | Experimental | Behavioral: Flipped-Discharge Education ModelParticipants 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. |
| Routine Education | Active comparator | Behavioral: Routine Discharge EducationParticipants received routine discharge education, including standard written and verbal PTCD catheter care instructions and post-discharge precautions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Psychiatric disorders
- Active severe infection
- Hematologic disease
- Language barriers
- Anticipated loss to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flipped-Discharge Education ModelStructured 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. | Behavioural | Flipped-Discharge Education |
| Routine Discharge EducationStandard 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. | Behavioural | Routine Education |
Primary outcome
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.
3 secondary outcomes
Family functioning as assessed by the Family APGAR
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Biliary Tract Neoplasms, Biliary Drainage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xia Xiang, BS principal investigator
First People's Hospital of Foshan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flipped-Discharge Education Model and Routine Discharge Education in people with Malignant Obstructive Jaundice, run by First People's Hospital of Foshan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness for hospital discharge as assessed by the Readiness for Hospital Discharge Scale (RHDS)-Adult Form (time frame: Approximately 28 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.