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Completed

NCT Number: NCT06749873

Assessing Hp Diagnosis and Treatment Quality of direct-to Consumer Telemedicine in Mainland China

A quality assessment of the level of H. pylori diagnosis and treatment in mainland China's Direct-to-consumer telemedicine (DTCT) was conducted by means of Unannounced standardized patients (USPs).

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandoang, China

About this study

Direct-to-consumer telemedicine (DTCT) refers to a model in which doctors provide medical advice and services directly to patients through the Internet and communication technologies. Under the background of globalization and information age, DTCT, as an innovative medical service model, is gradually changing the traditional face of the medical industry. Especially in today's highly developed information and network, telemedicine service has become an important way to improve the accessibility of medical services, reduce medical costs, and optimize the allocation of medical resources. In China, with the in-depth implementation of the Healthy China strategy, DTCT is regarded as a key link to deepen medical reform and build a new medical service system. In 2018, the Chinese government began to introduce a series of DTCT policy measures to promote the development of telemedicine. By June 2022, China has approved and set up more than 1,700 Internet hospitals, initially forming an integrated online and offline medical services2. As of February 2024, China's National Health Commission has approved the establishment of more than 2,700 Internet hospitals across the country. In addition to the Internet hospitals dominated by physical hospitals, the enterprise-led Internet medical consulting platform has also gradually flourished and gradually occupied a large market share.

The speed of development of DTCT is encouraging, but the quality of care in DTCT is more uncertain. In 2024, a Chinese study published was the first to evaluate multi-disease online diagnosis and treatment services offered on Chinese Internet diagnosis and treatment platforms, using anonymous standardized patients. The study found that the current quality of Internet diagnosis and treatment services is not ideal: out of 170 anonymous consultations, the access success rate is only 63.5% (108/170); Of the visits successfully completed, only 49 consultations (45%) resulted in a correct diagnosis. In terms of physician adherence to the guidelines, the rate of completion of consultation and disposal was 15% and 31%, respectively.

Helicobacter pylori (Hp) infection is a common gastrointestinal disease, which is closely related to the occurrence of gastritis, peptic ulcer, gastric cancer and other diseases. Globally, 43.1% of the population is infected with Helicobacter pylori. In China, the infection rate is also close to 50%. Hp infection has a huge demand for treatment, and it also faces many problems such as complicated treatment plan. Direct-to-consumer telemedicine services offer new possibilities for the treatment of Hp infection, greatly facilitating patients, especially those in remote areas and primary care facilities. However, there is uncertainty in the quality of H. pylori treatment in telemedicine services.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • An Internet hospital dominated by physical hospitals in the seven geographical regions of gastroenterology specialty reputation shortlisted by the Hospital Research Institute of Fudan University in China
  • Be included in the top 20 enterprise-led Internet medical consulting platforms based on popularity and user recognition

Exclusion criteria

  • Physical hospitals without Internet hospitals
  • The entity hospital of the Internet hospital can only be revisited

Treatment and study plan

Background of different SP information

Other

Sp was asked with the following baseline information: 1. 50 years of age and gender; 2. positive urea breath test; 3. asymptomatic; 4. family history of gastric cancer; 5. gastroscopy: atrophic gastritis; 6. untreated; and 7. no history of drug allergies.

Primary outcomes

  1. Guidelines compliance

    Time frame: 3 months

    For the doctor's inquiry through SP, the doctor's answer will be scored against the current guidelines, and the correct answer according to the guidelines will get the corresponding score, out of 10 points. Adherence to the physician's guidelines will be judged by the high or low scores assessed.

  2. Patient satisfaction

    Time frame: 3 months

    Through the SP for the doctor's inquiry, the doctor's attitude will be scored, and the corresponding score will be obtained. The patient's satisfaction with the physician will be judged by the high or low score of the assessment

Secondary outcomes

  1. Response rate

    Time frame: 3 months

    Ratio of physician responses to consultations in Internet hospitals

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Assessing Helicobacter Pylori Diagnosis and Treatment Quality of direct-to Consumer Telemedicine in Mainland China: a Cross-sectional Study Using Unannounced Standardised Patients

Acronym: Hp

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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