Clinical trial NCT06749873: Assessing Hp Diagnosis and Treatment Quality of direct-to Consumer Telemedicine in Mainland China
Official title: Assessing Helicobacter Pylori Diagnosis and Treatment Quality of direct-to Consumer Telemedicine in Mainland China: a Cross-sectional Study Using Unannounced Standardised Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Undeclared Standardized patient (USP) usually refers to a teaching tool used in medical education and training. These standardized patients are trained actors who simulate the conditions, symptoms, and emotional responses of real patients to help physicians improve their clinical skills. In the "undeclared" scenario, these standardized patients may not reveal their identity at the outset, but participate in training or evaluation as real patients, allowing medicine to diagnose and treat without prior preparation. This approach can more realistically simulate the clinical environment and help improve clinical thinking skills, communication skills and understanding of patients.

It is expected that 10 research assistants will be included for USP training.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Guidelines compliance
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Response rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandoang
Study officials:
References: