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This study aims to address the prevalence of undiagnosed hypertension and diabetes by assessing the impact of the FOR-Care model on preventive medicine. The model focuses on improving the documentation of blood pressure, height, and weight in outpatient settings. Through a cluster randomized trial at National Taiwan University Hospital, clinics will either implement the FOR-Care model or continue with usual care. The trial will evaluate the effectiveness of the intervention in documenting these measurements and its impact on diagnosing hypertension and diabetes. The outcomes will provide valuable insights into enhancing preventive medicine and improving care for chronic diseases.
Background: The prevalence of undiagnosed hypertension and diabetes among adults is considerable. For those already diagnosed with hypertension and diabetes, monitoring blood pressure and controlling body weight are recognized as essential methods for risk assessment. However, in outpatient settings, there is still room for improvement in the on-site documentation of blood pressure, height, and weight.
Objective: This cluster randomized trial (CRT) will assess the effects of preventive medicine following the implementation of the FOR-Care model, a technique designed for facilitating on-site recordings of office blood pressure, height, and weight.
Methods: The investigators will conduct a pragmatic CRT at the outpatient clinics of the Department of Family Medicine, National Taiwan University Hospital. A total of 42 clinics with over 15 patients will be randomized into two groups. The intervention group will adopt a FOR-Care model, required to measure and record blood pressure, height, and weight before consultations; while the control group receives usual care. The protected medical information will be accessed through the National Taiwan University Hospital Integrative Medical Database (NTUH-iMD). The quality improvement outcome is documentation of on-site blood pressure, height, and weight recordings of both groups at 12 and 24 weeks (cluster-level parameter). The primary preventive medicine outcome is newly diagnosed hypertension and diabetes mellitus (individual-level parameter). The secondary preventive medicine outcomes are clinical indicators of hypertension and diabetes mellitus in those with these diagnoses (individual-level parameters).
Expected Outcomes: The results of this pragmatic CRT will shed new insight into preventive medicine and quality of care in the management of common chronic diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention Group | No Intervention | This group does not specifically encourage or interfere with physicians' original methods of inquiry or patients providing bodily examination data. | |
| Intervention Group | Experimental | This group encourages physicians to actively inquire or patients to voluntarily provide physical examination data during consultations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Height, Weight, and Blood Pressure Measurement Procedures Improvement | Diagnostic Test | In the intervention group, the investigators improve the process of measuring blood pressure, height, and weight, requiring timely recording of these measurements. The intervention includes: i. Enlisting the assistance of nurses and volunteers to improve the accessibility of measurement environments and provide guidance on instrument operation. ii. Using paper reminders at check-in stations to prompt patients to complete blood pressure and weight recordings before entering examination rooms; providing paper for recording if patients forget their health insurance cards. iii. Providing alcohol and hand wipes outside examination rooms for disinfecting measurement instruments. iv. Promoting the recording mode outside the check-in station. v. Ensuring that physicians or nurses in examination rooms accurately record measurements in the medical order system. vi. Encouraging patients to ask physicians during consultations, "Is my blood pressure and weight okay?" |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with Documented On-Site Blood Pressure, Height, and Weight Recordings | The documentation of on-site blood pressure, height, and weight recordings | From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward |
| Rate of Newly-Diagnosed Hypertension | Assessing whether the improvement in documentation of on-site blood pressure, height, and weight recordings increases the diagnosis rates of hypertension. | From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward |
| Rate of Newly-Diagnosed Diabetes Mellitus | Assessing whether the improvement in documentation of on-site blood pressure, height, and weight recordings increases the diagnosis rates of diabetes mellitus. | From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward |
| Measure | Description | Time Frame |
|---|---|---|
| Office Blood Pressure in Hypertensionsive Patients | Assessing whether the intervention affects clinical indicators of hypertension | From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward |
| Home Blood Pressure in Hypertensionsive Patients |
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Cluster-level inclusion criteria:
Cluster-level exclusion criteria:
Patient-level exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Chien-Hsieh Chiang, MD, MPH, PhD | Family MedicineClinical Assistant Professor, Department of Family Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
However, de-identified data regarding the pre-defined outcomes or relevant characteristics could be available per request.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D001835 | Body Weight |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D001827 | Body Height |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
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|
Assessing whether the intervention affects clinical indicators of hypertension |
| From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward |
| Estimated Glomerular Filtration Rate | Assessing whether the intervention affects renal function (all patients) | From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward |
| Urinary Microalbumin Excretion | Assessing whether the intervention affects renal function (all patients) | From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward |
| Mortality Rate | Assessing whether the intervention affects longterm survival status | From date of randomization until the date of first documented progression, assessed up to 36 months |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000067029 | Physical Appearance, Body |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
| D006128 | Growth |
| D048788 | Growth and Development |