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Study to Evaluate Satisfaction Using Personal Health Wallet Service

Primary Purpose

Emergencies

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Personal health wallet service for emergency situation
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Emergencies

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. SUS-based usability assessment and survey

    • Patient and caregivers of emergency room at Samsung Medical Center
    • Adults over 19 years old.
    • Those who voluntarily agreed to participate in the research
    • Patients who are past the acute period and in stable condition can agree with them
  2. Interview

    • Users of the personal health wallet service for emergency situations among patients and caregivers in the emergency room of Samsung Medical Center
    • Medical staffs at Samsung Medical Center and associated hospitals
    • Adults over 19 years old.
    • Those who voluntarily agreed to participate in the research

Exclusion Criteria:

  1. SUS-based usability assessment and survey

    • 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. )
  2. Interview

    • Patient is the same as SUS based usability assessment and exclusion criteria for survey participants
    • In the case of medical staffs, those who do not agree with this study

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients(Care givers)

Medical staffs

Arm Description

1,000 patients(caregivers) are enrolled and use the personal health wallet service. They fill out questionnaire to evaluate the service Some of them are invited for an in-depth interview.

12 medical staffs are enrolled and use the personal health wallet service. After that, they are invited for an in-depth interview.

Outcomes

Primary Outcome Measures

SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health care for emergency situations
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health care for emergency situations. 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.

Secondary Outcome Measures

A qualitative study on the satisfaction of patients(caregivers) and medical staffs through interviews
A qualitative study on the satisfaction of patients(caregivers) and medical staffs through interviews

Full Information

First Posted
November 26, 2019
Last Updated
December 1, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04180618
Brief Title
Study to Evaluate Satisfaction Using Personal Health Wallet Service
Official Title
Multi-centered Study to Evaluate Patient Satisfaction and Work Efficiency of Medical Staff When Using Personal Health Wallet Service for Emergency Situation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
November 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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 three 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.
Detailed Description
Background: In emergency situations there are difficulties for treatment in that patient health records are not immediately provided because patient information is separately managed by each hospital. Another reason for the difficulty is that if the patients don't know their personal health record, they can't inform medical staffs of it. In addition, the increase of emergency situation of the chronically ill is also problematic. And patients have a growing desire for their health information. In this situation, 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. Objective: This study evaluates the effectiveness and satisfaction of the developed service in the emergency situation Design: Mixed method(questionnaires and interview) Setting: In the Department of Emergency at the Samsung Medical Center, the Asan Medical Center, the Dong-A Medical Center, and cooperative hospitals Enrollment: 1,000 patients(care givers) and about 12 medical staffs Intervention Patients or care givers 1,000 patients(care givers) are enrolled and use the personal health wallet service. The participants fill out questionnaire to evaluate the service Some of them are invited for an in-depth interview. Medical staffs About 12 medical staffs are enrolled and use the personal health wallet service. After that, the medical staffs are invited for an in-depth interview.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1010 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients(Care givers)
Arm Type
Experimental
Arm Description
1,000 patients(caregivers) are enrolled and use the personal health wallet service. They fill out questionnaire to evaluate the service Some of them are invited for an in-depth interview.
Arm Title
Medical staffs
Arm Type
Experimental
Arm Description
12 medical staffs are enrolled and use the personal health wallet service. After that, they are invited for an in-depth interview.
Intervention Type
Other
Intervention Name(s)
Personal health wallet service for emergency situation
Intervention Description
Patients(caregivers) and medical staffs will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service.
Primary Outcome Measure Information:
Title
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health care for emergency situations
Description
SUS(System Usability Scale)-based assessment of patients or care givers satisfaction using personal health care for emergency situations. 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.
Time Frame
2 month for enrollment and study
Secondary Outcome Measure Information:
Title
A qualitative study on the satisfaction of patients(caregivers) and medical staffs through interviews
Description
A qualitative study on the satisfaction of patients(caregivers) and medical staffs through interviews
Time Frame
2 month for enrollment and study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: SUS-based usability assessment and survey Patient and caregivers of emergency room at Samsung Medical Center Adults over 19 years old. Those who voluntarily agreed to participate in the research Patients who are past the acute period and in stable condition can agree with them Interview Users of the personal health wallet service for emergency situations among patients and caregivers in the emergency room of Samsung Medical Center Medical staffs at Samsung Medical Center and associated hospitals Adults over 19 years old. Those who voluntarily agreed to participate in the research Exclusion Criteria: SUS-based usability assessment and survey 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. ) Interview Patient is the same as SUS based usability assessment and exclusion criteria for survey participants In the case of medical staffs, those who do not agree with this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taerim KIM
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33320102
Citation
Kim SM, Kim T, Cha WC, Lee JH, Kwon IH, Choi Y, Kim JS. User Experience of Mobile Personal Health Records for the Emergency Department: Mixed Methods Study. JMIR Mhealth Uhealth. 2020 Dec 15;8(12):e24326. doi: 10.2196/24326.
Results Reference
derived

Learn more about this trial

Study to Evaluate Satisfaction Using Personal Health Wallet Service

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