Evaluation of telemedicine-based training for rural primary healthcare providers in China: A randomized controlled trial

ISRCTN	ISRCTN70330907
DOI	https://doi.org/10.1186/ISRCTN70330907
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	AEARCTR-0010327
Sponsor	Shaanxi Normal University
Funder	UBS Optimus Foundation

Submission date: 11/11/2022
Registration date: 23/11/2022
Last edited: 16/09/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Digital technologies have the potential to address some challenges in providing high-quality and equitable healthcare services. In particular, telemedicine services can overcome geographical barriers and provide health service/training to residents/healthcare workers in remote and undeveloped areas. Previous studies have documented the poor quality of primary health care in rural areas of China. This study aims to assess whether a telemedicine-based training program could improve the quality of care delivered by primary healthcare providers in rural areas and what influences rural primary healthcare providers’ engagement in the program.

Who can participate?
Village doctors from rural primary healthcare centers who were practicing Western medicine from randomly selected villages and households in each selected village

What does the study involve?
Following a baseline survey, 40 townships in our trial were randomly assigned to either the intervention group or the control group. In the intervention group, sample primary healthcare providers were offered the opportunity to participate in a telemedicine-based training program for 7 months. Sample primary healthcare providers in the control group did not receive any intervention. Within three months after the training program ended, sample primary healthcare providers were followed up to assess their clinical knowledge and practices, and sample rural residents were followed up to assess patient satisfaction, utilization of primary medical services, their own health behavior and knowledge, as well as health services provided by doctors in their village clinic and township health center.

What are the possible benefits and risks of participating?
The study was expected to benefit rural primary healthcare providers and residents in the townships randomly assigned to the intervention group. Potential benefits to primary healthcare providers include improved clinical knowledge. Rural residents served by primary healthcare providers in the intervention group may benefit from improved care. There are no risks involved in participating in this study.

Where is the study run from?
Shaanxi Normal University (China)

When is the study starting and how long is it expected to run for?
August 2019 to August 2022

Who is funding the study?
UBS Optimus Foundation (Switzerland)

Who is the main contact?
1.Qiufeng Gao, gqiufeng820@163.com
2.Yaojiang Shi, shiyaojiang7@gmail.com

Contact information

Dr Qiufeng Gao
Scientific

Center for Experimental Economics in Education
Shaanxi Normal University
620 Chang'an Rd West
Chang'an District
Shaanxi Province
Xi’an
710119
China

Phone	+86 18292486884
Email	gqiufeng820@163.com

Prof Yaojiang Shi
Scientific

Center for Experimental Economics in Education
Shaanxi Normal University
620 Chang'an Rd West
Chang'an District
Shaanxi Province
Xi’an
710119
China

ORCID ID	0000-0002-0927-0360
Phone	+86 13892833777
Email	shiyaojiang7@gmail.com

Dr Qiufeng Gao
Principal investigator

Center for Experimental Economics in Education
Shaanxi Normal University
620 Chang'an Rd West
Chang'an District
Shaanxi Province
Xi’an
710119
China

ORCID ID	0000-0001-6497-7521
Phone	+86 18292486884
Email	gqiufeng820@163.com

Study information

Primary study design	Interventional
Study design	Interventional cluster randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Telemedicine-based training and the quality of primary care in rural China: A randomized controlled trial
Study objectives	The telemedicine-based training intervention developed for rural primary healthcare providers will improve providers’ clinical knowledge and practices. Participants in the intervention condition will improve more on the primary and secondary outcomes than participants in the control condition.
Ethics approval(s)	1. Approved 22/06/2020, Xi’an Jiaotong University Institutional Review Board (No. 76, Yanta Road West, Yanta District, Xi'an 710061, China; +86 29 82757512; gengjz@xjtu.edu.cn), ref: IRB2020-1239 2. Approved 17/12/2019, Xi’an Gaoxin Hospital Institutional Review Board (No. 16, Tuanjie Road South, Yanta District, Xi'an 710077, China; +86 29 88332206, gxyyec@163.com), ref: IRB2019-KY005
Health condition(s) or problem(s) studied	Primary healthcare quality
Intervention	Within each cluster, sample primary healthcare providers and sample rural residents were randomly selected by computer software. We combined stratified randomization at the county level with clustered randomization at the township level. Specifically, within each county, we planned to use a computerized random number generator to randomly assign half townships to the intervention group and the other half to the control group. Since the number of townships in the sample counties was unevenly distributed, we ultimately assigned 19 townships to the intervention group and 21 townships to the control group by computer software. In each township, we randomly selected 3 eligible doctors in the township health center using a computerized random number generator and included all of the village doctors from 3 randomly selected villages. These doctors were included in our trial and are hereafter referred to as “sample primary healthcare providers.” For each selected village, we used a computerized random number generator to randomly select 5 households to take surveys (hereafter, “sample rural residents”). Sample primary healthcare providers in the intervention group were invited to participate in a telemedicine-based training program for 7 months. During this program, online training and teleconsultation services were provided by experts in an urban comprehensive tertiary hospital who were qualified at least as attending physicians. The voluntary online training consisted of 31 sessions covering a series of common diseases in rural areas. Teleconsultation creates a hands-on approach to learning: sample primary healthcare providers could contact experts via teleconsultation when they needed help with patient cases, which served as another form of training and allowed for learning by doing. Sample primary healthcare providers were allowed to use the teleconsultation services for free during business hours. Sample primary healthcare providers in the control group did not receive any intervention.
Intervention type	Behavioural
Primary outcome measure(s)	1. Clinical knowledge of primary healthcare providers measured using the Vignettes Method and Structural Questionnaire Test within three months after the training program ended Each primary healthcare provider in the sample was administered Vignettes presenting three disease cases: asthma, unstable angina, and child diarrhea. The analysis will focus on process quality, the correctness of diagnoses, and the appropriateness of treatment, which will all be evaluated by experts. A series of ten test items related to common diseases were adopted in a structural questionnaire. The test scores will be calculated based on the number of correctly answered test items, which will also be evaluated by experts. 2. Clinical practice of primary healthcare providers measured using the Standardized Patients Method within three months after the training program ended Unannounced standardized patients (hereafter, “SPs”) were used to assess the clinical practice of primary healthcare providers. We chose three cases presented by Standardized Patients: asthma, unstable angina, and child diarrhea. In principle, each primary healthcare provider received 0 to 2 cases of SP visits based on predetermined rules. The analysis will focus on process quality, the correctness of diagnoses, the appropriateness of treatment, and consultation length, which will all be evaluated by experts.
Key secondary outcome measure(s)	All outcomes are measured within three months after the training program ended： 1. Patient satisfaction with primary healthcare providers is reported by unannounced standardized patients and sample rural residents using the patient experience questionnaire 2. Utilization of primary medical services collected from sample rural residents measured by the frequency of their visits to primary health facilities. Patient load was measured by the number of patient visits reported by sample primary healthcare providers. 3. Health behavior of sample primary healthcare providers collected from sample rural residents measured by how often primary health providers offer chronic disease management services 4. Health behavior and knowledge of residents reported by sample rural residents measured by their medication adherence and self-monitoring of chronic diseases. Health knowledge of residents was measured by a series of test items on chronic diseases.
Completion date	31/08/2022

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	840
Total final enrolment	279
Key inclusion criteria	Primary healthcare providers: 1. Aged 18 years old and over 2. Male or female 3. Employed as doctors who were practicing Western medicine in village clinics and township health centers in the study area Rural residents who were invited to take household surveys: 1. Aged 18 years old and over 2. Male or female 3. Permanent residents in villages in the study area
Key exclusion criteria	1. Primary healthcare providers who were only practicing traditional Chinese medicine 2. Rural residents who were unable to take the survey because of cognitive dysfunction or were temporarily living in the surveyed village
Date of first enrolment	01/01/2021
Date of final enrolment	31/12/2021

Locations

Countries of recruitment

China

Study participating centre

Center for Experimental Economics in Education at Shaanxi Normal University

Shaanxi Normal University
620 Chang'an Rd West
Chang'an District
Shaanxi Province
Xi’an
710119
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other files			16/09/2024	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN70330907_Summary of the participants and flow.pdf: Other files

Editorial Notes

16/09/2024: Summary of participants sampling and flow added as an additional file.
04/07/2024: The intention to publish date was changed from 31/07/2024 to 31/07/2025.
05/12/2023: Total final enrolment added. The intention to publish date was changed from 31/12/2023 to 31/07/2024.
15/11/2022: Trial's existence confirmed by Xi'an Jiaotong University School of Medicine Biomedical Ethics Review Application Form.