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

Peking University

Status: Not yet enrolling

Conditions: Hypertension; Diabetes Mellitus Type 2; Cardiovascular Diseases

Treatments: Behavioral: Strengthened health education; Other: Financial incentives for integration of care; Procedure: Risk-stratified care pathway; Other: Team-based care; Other: Supporting health information system

Study type: Interventional

Funder types: Other

Identifiers

NCT06302127

CCHDS

Details and patient eligibility

About

The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management.

Enrollment: 2,560 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged between 40 and 70 years old;
2. Patients with hypertension or diabetes;
3. Permanent residents of the county where the research is conducted;
4. Already signed up with the family doctor team in the township where the research is located.

Exclusion criteria

1. Unable to independently carry out the interventions required for the study;
2. Residing far from the village or township health center where the research is located, making it difficult to cooperate with visits;
3. Patients who refuse to participate;
4. Patients with comorbidities such as cancer that may interfere with the study visits or intervention effects;
5. Pregnant or lactating women

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,560 participants in 2 patient groups

Control

No Intervention group

Description:

During the study, control participant will be provided with existing essential public health service including quarterly follow-ups and annual physical examination, and be advised to see their usual provider for care, as appropriate.

Intervention

Experimental group

Description:

Intervention group will receive the risk-stratified integrated CVD management (RISIMA) model consisting of 5 core elements provided as a package: (1) Team-based care; (2) Risk-stratified care pathway; (3) Strengthened health education; (4) Financial incentives for integration of care; (5) Supporting health information system.

Treatment:

Other: Financial incentives for integration of care

Procedure: Risk-stratified care pathway

Behavioral: Strengthened health education

Other: Team-based care

Other: Supporting health information system