A Study to Evaluate Satisfaction of the Personal Health Record Platform for Chronic Patients in Emergency Department

A Multi-institutional Study to Evaluate Patient Satisfaction of the Personal Health Record Management Platform for Chronic Patients in Emergency Department Based on Actual Demand

The investigators developed the service showing patient health record altogether which is managed by each hospital separately and recording the patient health information based on mobile application. This study is a multi-centered study involving two hospitals, providing services to patients, care givers and medical staffs. After the participants use this service, the investigators evaluate the effectiveness and satisfaction of this service through questionnaires and in-depth interviews.

Study Overview

• Status: Completed
• Conditions: Emergencies, Chronic Disease
• Intervention / Treatment: Other: Personal health wallet service for Chronic Patients in Emergency Department

Detailed Description

<Background> Emergency situations for chronic patients are increasing due to aging, eating habits and lifestyle changes. For chronic patients, comprehensive health records and utilization are important for health care and emergency situations. In particular, in the event of an emergency, information on the patient's personal health records, such as recent surgery records, disease history, prescription and dosage history is needed immediately, but it is difficult to check separately for each hospital. In addition, in emergencies, it may take more time for proper treatment to take place if patients themselves cannot directly talk about their medication or past surgical history, or if they are unable to communicate with patients. Recently, conditions have been prepared for the collection and utilization of personal health record information due to changes in policy and technology environment, making it possible to provide services for emergency patients with chronic diseases.

<Objective> To establish a service for collection and utilization of medical records (care, examination, surgery, prescription records) and PGHD for chronic patients and to evaluate its effectiveness.

<Design> Mixed methods study (questionnaires and interview)

<Setting> At the Samsung Medical Center and the Dong-A Medical Center.

<Enrollment> 400 patients(care givers)

<Intervention>

1. 400 patients(care givers) are enrolled and use the personal health wallet service. (Personal Health Record service)
2. The participants fill out questionnaire to evaluate the service
3. Some of them are invited for an in-depth interview.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taerim Kim; Phone Number: 82-10-7114-2342; Email: taerim.j.kim@gmail.com
• Study Contact Backup: Name: Su Min Kim; Phone Number: 82-10-2034-0550; Email: flyhighsoom@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 04742
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

<Inclusion Criteria>

• A chronic patient (or his or her care giver) who visits the emergency department and has a plan to visit outpatient or other hospitals in one month of the visiting emergency department.
• Adults over 19 years old.
• Those who voluntarily agreed to participate in the research

<Exclusion Criteria>

• Anyone who disagrees with this study
• Patients who are not conscious when leaving the emergency room, patients who are not aware of or are not aware of their orientation, patients who are not aware of their level of awareness, or people who are in shock or in deep shutdown situations) (Even in the above cases, caregivers can be included in the clinical trial target if they are present. )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients(Care givers); 400 patients(caregivers) are enrolled and use the personal health wallet service (Personal Health Records service).; They fill out questionnaire to evaluate the service; Some of them are invited for an in-depth interview.	Other: Personal health wallet service for Chronic Patients in Emergency Department; Patients(caregivers) will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.	SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Its score range is 0~100 and the higher the score, the higher the satisfaction level.	The day of the enrollment of the study
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.	SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Its score range is 0~100 and the higher the score, the higher the satisfaction level.	2 weeks after the enrollment
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.	SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Its score range is 0~100 and the higher the score, the higher the satisfaction level.	4 weeks after the enrollment
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service.	SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health wallet service. SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Its score range is 0~100 and the higher the score, the higher the satisfaction level.	8 weeks after the enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A qualitative study on the satisfaction of patients or care givers through interviews	A qualitative study on the satisfaction of patients or caregivers through interviews	through study completion, an average of 3 months"
A quantitative or qualitative study on the log data of the application	A quantitative or qualitative study on the log data of the application	through study completion, an average of 3 months"

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Chronic Disease
• Other Study ID Numbers: 2021-03-019-006

Drug and device information, study documents

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