NCT04186104

Brief Summary

In China, the number of children's medical services is still far behind the growing demand for children's health care. The phenomenon of children's parents queuing overnight for registration is no longer surprising. This is because of the increase in the number of children and the shortage of pediatric talents. In the department of pediatrics, the number of patients increases year by year, but pediatrician is short of supply from beginning to end. In addition to outpatient service, pediatricians in large hospitals also perform operations, scientific research and other tasks. As a result, many doctors have to give up their vacations, which makes them miserable and reduces their enthusiasm for work. The long queuing time also reduced the satisfaction of patients, resulting in the intensification of the conflict between pediatric doctors and patients. This research project aims to create a human-computer integrated system and develop a new diagnosis process embedded with artificial intelligence (AI). The function of AI system mainly includes 3 aspects. (1) The patient uses a mobile phone application embedded with AI that allows him to have check-up before see a doctor. The program will ask the patient a number of questions. Then, based on the patient's answers, AI will recommend a series of examination, all of which would be reviewed by the physician beforehand. After the patient pays for it, he could go straight to do the examination. So, next he could go to the doctor with the examination report which saves the patient the trouble of queuing. (2) At the same time, the AI system could also automate the medical history. The patient would complete self-help history collection in the spare time. The AI system collects the medical history and automatically import it to the doctor's computer. Doctors' main job is to modify the medical history generated by AI. To some extent, it lightens the burden of doctors. (3) During the visit, the AI system automatically captures the information in the patient's electronic medical record and generates the possible diagnosis. This process is of great help to junior doctors, and may serve as a cue. In short, this study is helpful to effectively reduce the waiting time of patients and greatly increase their medical experience. While reducing the work intensity of doctors, the outpatient procedure of our hospital has been effectively optimized to alleviate the shortage of pediatricians to some extent.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
626

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

March 21, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

November 12, 2019

Last Update Submit

June 28, 2021

Conditions

Keywords

Artificial IntelligenceOutpatientprocess improvement

Outcome Measures

Primary Outcomes (1)

  • Evaluate the efficiency of the two processes

    Compare the average waiting time for single patient and average visiting time for single patient.

    up to 1 months

Secondary Outcomes (3)

  • Evaluate patients' rate of satisfaction for medical processes

    up to 1 months

  • Economic measurements

    up to 1 months

  • Work efficiency of doctors

    up to 1 months

Study Arms (2)

Patients with routine outpatient service process

EXPERIMENTAL

After registration, the patient waits in line at the door of the doctor's office. His doctor uses traditional methods to enter medical records by hand and make diagnosis independently. Then the patient waits in line to pay the bill and queues up for examination. Finally, the patient would take the examination report back to the doctor.

Other: Routine diagnostic process

Patients with AI assisted outpatient service process

EXPERIMENTAL

After registration, the patient binds his information to the mobile phone application through outpatient' number. First, AI system would ask the patient a series of questions. Then it would make a judgment based on the patient's response. The system transmits the examination items to the doctor's computer and, with the doctor's approval, sends items back to the patient. So, patient could go straight to do the examination. While waiting for his turn, the patient enters the phone program again, and the AI system collects his medical history. The information is sent back to the doctor. When the patient goes to the doctor's office with the examination report, the doctor's computer already has his medical records. The doctor only needs to adjust the history according to the actual situation. After writing the medical history, the AI system could automatically make the diagnosis. Doctor uses the AI' results and his own judgment to make a comprehensive diagnosis.

Other: Artificial intelligence assisted diagnosis process

Interventions

Patients follow the procedures of registration, waiting, attendance, waiting, examination, waiting, attendance.

Patients with routine outpatient service process

Patients follow the procedures of registration, AI recommended examination items, Self-service medical history collection ,examination, waiting, AI-assisted attendance.

Patients with AI assisted outpatient service process

Eligibility Criteria

Age2 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged 2 months to 18 years old and will go to Shanghai children's medical center for treatment.

You may not qualify if:

  • People who don't agree to participate.
  • People who can't cooperate.
  • People who are difficult to follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Shanghai Children's Medical Center

Shanghai, China

Location

Related Publications (16)

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    PMID: 28126242BACKGROUND
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    PMID: 3276267BACKGROUND
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    PMID: 23683341BACKGROUND
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    PMID: 29251699BACKGROUND
  • Kapoor R, Walters SP, Al-Aswad LA. The current state of artificial intelligence in ophthalmology. Surv Ophthalmol. 2019 Mar-Apr;64(2):233-240. doi: 10.1016/j.survophthal.2018.09.002. Epub 2018 Sep 22.

    PMID: 30248307BACKGROUND
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    PMID: 30404897BACKGROUND
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    PMID: 24338557BACKGROUND
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    PMID: 29754806BACKGROUND
  • Huang Q, Zhang F, Li X. Machine Learning in Ultrasound Computer-Aided Diagnostic Systems: A Survey. Biomed Res Int. 2018 Mar 4;2018:5137904. doi: 10.1155/2018/5137904. eCollection 2018.

    PMID: 29687000BACKGROUND
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    PMID: 31830558BACKGROUND
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    PMID: 31767194BACKGROUND
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    PMID: 31826337BACKGROUND
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    PMID: 21525569BACKGROUND

Study Officials

  • Shijian Liu, Ph.D

    Shanghai Children's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
staff of Research Department

Study Record Dates

First Submitted

November 12, 2019

First Posted

December 4, 2019

Study Start

March 21, 2020

Primary Completion

June 29, 2021

Study Completion

June 29, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations