County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 40 to 70 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Hypertension, Diabetes Mellitus Type 2, Cardiovascular Diseases

Being tested

Team-based care, Risk-stratified care pathway, Strengthened health education, Financial incentives for integration of care, Supporting health information system

Medical subject headings

Hypertension, Diabetes Mellitus, Type 2, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Team-based careOther

  The RISIMA model is provided by a family healthcare team composed of one village doctor, one general physician at township health centers and one specialist including cardiologists, neurologists or endocrinologists from county hospital. For villages without village doctor, public health professionals from township health centers would join the service team as the supplement. Within the team, three team members carry the different function. Village doctor is responsible for regular home visits, CVD risk measurement and organizing health education course. GP as the core service provider in the team is responsible for CVD risk monitoring, providing health education course for middle-high risk participants, and generating integrated care plans for each participant. Specialist is responsible for providing guidance particularly for high-risk population management to township and village doctors within the team.

• Risk-stratified care pathwayProcedure or surgery

  Based on WHO/ISH score, baseline population will be divided into three groups-low risk (10-year CVD risk: \<10%), middle risk (10-year CVD risk: 10%~20%) and high risk (10-year risk: \>20%). With the support from experts and health care professionals, study had developed a risk-stratified care pathway on the basis of clinical guidance. According to the pathway, participants at different risk tertile are provided with differentiated management plan especially in terms of health education, follow-up frequency and treatment plan.

• Strengthened health educationBehavioural

  The education comprised 8 monthly sessions developed by GP and village doctors. At the 4th month, individual health counseling by village doctors will be done to encourage the imitation and maintenance of self-management behaviors, and to identify any potential problems in the program. It took half an hour per each participant. At the 8th month, self-management evaluation will be done to assess personal self-management ability. High risk participants are required to take the education course, and middle risk participants are only encouraging to take. All participants would receive the education messages twice a month, which introduce tips about the management of hypertension, diabetes and CVD risk factors.

• Financial incentives for integration of careOther

  Specialists receive reimbursement for case discussion and high risk population management; GP receive reimbursement for providing education program and risk monitoring; Village doctor receive reimbursement for assisting education program, risk measurement and home visits. And overall services quality will be measured, and taken into account for annual performance evaluation.

• Supporting health information systemOther

  A dynamic patient risk monitoring information system is established for simplifying the risk data collection and entry for village doctors, meanwhile, GP and specialist can receive the updates of risk scores simultaneously. Apart from the function of risk monitoring, this system also incorporates the e-records of home visits, health education attendance as well as medical records including outpatient visits and hospitalizations. The upgraded information systems not only can support the healthcare professionals with comprehensive and real-time data, but also provide the performance evaluation data for policymakers.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 10-year CVD risk score

   This study intervention is designed to address CVD risk by introducing an integrated care package. Therefore, a validated risk score is required to properly evaluate the effect of interventions. The WHO/ISH score is a tool to estimate the risk of CVD development based on age, sex, BP, total cholesterol, smoking and diabetes. The primary objective of this study is to evaluate whether or not the intervention can substantially lower the risk at 1 year. The primary outcome is the mean difference in WHO/ISH risk score change from baseline to 12 months between the intervention and control townships. The WHO/ISH risk score will be calculated using the lab-based measurements, but if there are missing, a nonlaboratory measurements will be used.

   Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted8 Mar 2024
2. Study start20 May 2024
3. Primary completion20 Oct 2025 (estimated)
4. Study completion20 Dec 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for HypertensionStudies of the same condition, open and under way.
• More trials run by Peking UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.