Pilot Study for the Validity of a Content-based Information Provision Tool Aimed at Improving the Hospitalization Experience of Liver Transplant Patients

The investigators aim to evaluate the improvement of the inpatient experience and the usability of a content-based tool (a brochure). This involves consolidating video content for inpatients on a single website and providing access to it via QR codes in a brochure format.

[Patients] Considering this as a pilot study, the investigators plan to recruit around 30 participants. Both the experimental and control groups will receive standard care and information, with the experimental group additionally receiving the brochure. Random assignment will be used for the experimental and control groups. Surveys and interviews will be conducted to assess changes in patient experience and usability before and after providing the brochure.

[Medical Staff] Among the medical staff involved in the liver transplant surgical process, researchers will select participants based on their degree of involvement with the intervention subjects. After obtaining their consent, interviews will be conducted concerning patient experiences and the brochure.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplantation; Inpatients
• Intervention / Treatment: Other: Consolidating content on a single website and providing access to it via QR codes in a brochure format

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Su Min Kim, Ph.D; Phone Number: 821020340550; Email: flyhighsoom@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

[Patients]

• Adults aged 18 and over
• Patients who are scheduled to undergo or have undergone liver transplant surgery
• Recruited through a call for research participants and have consented to participate in this study

[Medical Staff]

• Adults aged 18 and over
• Medical staff at Samsung Medical Center involved in the post-liver transplant treatment process

Exclusion Criteria:

[Patients]

• Individuals who have not consented to participate in this study
• Individuals whose health condition makes it difficult to participate in the intervention
• During the research period, the researcher will check if the brochure content has been shared during surveys or interviews with the research participants (information dissemination). If information dissemination is confirmed, the participant will be excluded from the study.

[Medical Staff]

• Individuals who have not consented to participate in this study
• Medical staff not involved in the liver transplant treatment process

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The group assigned as the control group will receive information in the same manner as it is currently provided to patients.; A survey related to patient experience evaluation will be conducted before discharge. The survey will take about 10 minutes.; The control group will undergo two interviews, one during hospitalization and one before discharge. Each interview will last approximately 30 minutes. Interviews will be recorded or transcribed, and the recordings will be used until the research objectives are met, after which they will be disposed of.
Experimental: Experimental Group; The group assigned as the experimental group will receive information in the same manner as it is currently provided to patients, with the addition of a brochure provided once when moving to a general ward after surgery. The brochure can then be used freely.; A survey related to patient experience evaluation will be conducted before discharge. For the experimental group, an additional survey regarding the provided brochure will be included. The survey will take about 15 minutes.; The experimental group will undergo two interviews, one during hospitalization and one before discharge. Each interview will last approximately 30 minutes. Interviews will be recorded or transcribed, and the recordings will be used until the research objectives are met, after which they will be disposed of.	Other: Consolidating content on a single website and providing access to it via QR codes in a brochure format; The group assigned to the experimental group will receive information in the same manner as current patients do, with the addition of receiving a brochure once when moving to a general ward after surgery. Afterward, they are free to use the brochure. The control group will receive information only in the manner currently provided to patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inpatient Experience 1	Inpatient Experience Evaluation Score, which ranges from a minimum of 0 to a maximum of 100 points, with higher scores indicating better patient experiences.	During the intervention
Inpatient Experience 2	Analysis of survey response trends and frequencies between the experimental and control groups	During the intervention
Inpatient Experience 3	Qualitative research through interviews	Patient: During the intervention and after intervention(Two times)/Medical staff: During the study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Informational value of the intervention tool	Asking informational value of the intervention tool from survey and interview	During the intervention
Usability value of the intervention tool	Survey uses 'System Usability Scail' which ranges a minimum of 0 to a maximum of 100 points, with higher scores indicating better usability. Also related question will be asked by intervew.	During the intervention
Regarding utilization of the intervention tool	A survey and interview on the experience of utilization during hospitalization	During the intervention
Areas for improvement	A survey and interview on the advice for improvement	During the intervention

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 21, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-04-078-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: From the start to the end of the study
• IPD Sharing Access Criteria: Shared with all researchers approved by the IRB
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No