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| Name | Class |
|---|---|
| Exhibition Road Community Health Service Center of Xicheng District, Beijing, China | UNKNOWN |
| Xinjiekou Community Health Service Center of Xicheng District, Beijing, China | UNKNOWN |
| Guanwai Community Health Service Center of Xicheng District, Beijing, China |
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Study types and hypotheses: multicenter randomized controlled trials. This study predicts that standardized anticoagulation management of atrial fibrillation in primary health care institutions can reduce the prevalence of atrial fibrillation stroke by 50%.
Formulation and revision of standardized anticoagulation management plan and process for atrial fibrillation in primary health care institutions.
Using the mature anticoagulation management model of atrial fibrillation for reference, based on the clinical data and disease management needs of patients with atrial fibrillation in five community health service centers in Xicheng District of Beijing. To formulate the anticoagulation management plan and process of atrial fibrillation suitable for grass-roots medical institutions. After the completion of the first draft of anticoagulation management plan and process, two rounds of multi-disciplinary experts were organized to demonstrate the feasibility and scientific nature of the first draft. Finally, based on the practice and effect evaluation of clinical application management, the scheme is revised and improved.
To evaluate the feasibility and clinical application effect of standardized anticoagulation management scheme and process for atrial fibrillation.
First of all, the baseline clinical database of patients with multicenter atrial fibrillation was established; secondly, patients with atrial fibrillation who met the entry criteria were randomly included in the trial group or control group and followed up for two years. The anticoagulation treatment rate, the incidence of bleeding and thromboembolic events, anticoagulation compliance rate and knowledge awareness rate of atrial fibrillation in the two groups were compared, and the effect of standardized anticoagulation management of atrial fibrillation in primary medical institutions was evaluated.
To organize experts to formulate a standardized anticoagulation management plan and process for atrial fibrillation in grass-roots medical institutions
To evaluate the clinical effect of standardized anticoagulation management scheme and process for atrial fibrillation.
Observation indicators Main outcome measures: the rate of anticoagulant therapy, the rate of reaching the standard of INR, the incidence of bleeding and thromboembolic events at 3 months, 6 months, 9 months, 12 months, 18 months and 24 months.
Secondary indicators: anticoagulant compliance rate and knowledge awareness rate of atrial fibrillation at 6 months, 12 months and 18 months. Blood routine: hemoglobin, platelet; biochemistry: glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, serum creatinine, urea nitrogen, glomerular filtration rate; electrocardiogram / dynamic electrocardiogram, echocardiography.
Follow-up plan Patients' symptoms and signs, diet and exercise in the process of anticoagulation management were followed up once a month, and when unmanageable new symptoms or drug side effects appeared, they were referred to secondary or tertiary hospitals for treatment in time; a regular comprehensive physical examination was arranged once a year, including blood routine, biochemical, ECG / dynamic electrocardiogram, echocardiography, etc., and the follow-up period was 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The standardized anticoagulation management program of atrial fibrillation in primary medical institutions was implemented for the patients with atrial fibrillation in the intervention group. |
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| Control group | Other | The current general practitioner management mode was continued for the patients with atrial fibrillation in the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions | Behavioral | Compared with the current anticoagulation management service, we pay more attention to early initiation of anticoagulant therapy and long-term follow-up management. |
| Measure | Description | Time Frame |
|---|---|---|
| Anticoagulant treatment rate, % | Anticoagulant therapy rate (%) = number of people actually receiving anticoagulant therapy / number of people who should receive anticoagulant therapy x 100%anticoagulant therapy / the total number of people who should receive anticoagulant therapy x 100%. | Change from Baseline Anticoagulant treatment rate at 24 months |
| Incidence of bleeding and thromboembolic events | Incidence of thromboembolic events / anticoagulation related bleeding events (%) = number of thromboembolic events / anticoagulation related bleeding events in a certain period / number of people observed in the same period x 100% (unit: person year) | Change from Baseline bleeding and thromboembolic events rate at 24 months |
| INR compliance rate | INR compliance rate (%) = the number of INR compliance (2.0 / 3.0) / the total number of INR monitored in the same period × 100% | Change from 12 months INR compliance rate at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anticoagulant compliance rate | Using the Chinese revised version of Morisky Drug Compliance scale | Change from 12 months INR compliance rate at 24 months |
| Knowledge awareness rate of atrial fibrillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lan Ding, Bachelor | Contact | 0086-13621031422 | 0086-68056002 | ytzxkyb@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xia J Wang, Master | FuXing Hospital, Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuetan Community Health Service Center Fu Xing Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 0086 | China |
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| UNKNOWN |
| Guannei Community Health Service Center of Xicheng District, Beijing, China | UNKNOWN |
Each community health service center randomly included patients with atrial fibrillation who met the admission criteria into the trial group or the control group. The intervention measures are the standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions.
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Single Blind
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| Conventional general practitioner management model | Behavioral | The current general practitioner anticoagulation management model was continued in the control group. |
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Awareness rate = the number of correct questions answered by the respondents / the total number of questions answered by the respondents x 100%.
| Change from 12 months INR compliance rate at 24 months |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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