Effects of FOR-Care Model on Preventive Medicine

Hypertension Clinical Trial

Official title:

Effects of Facilitating On-Site Recordings of Office Blood Pressure, Height, and Weight on Preventive Medicine - A Pragmatic Cluster Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406192
• Other study ID #: 202402048RIND
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2024
• Source: National Taiwan University Hospital
• Contact: Chien-Hsieh Chiang, MD, MPH, PhD
• Phone: +886-972651864
• Email: jiansie[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 30, 2027
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Cluster-level inclusion criteria:

• clinic sessions with at least 15 patients, but fewer than 40 patients

Cluster-level exclusion criteria:

• travel, hospice, vaccination, or health examination clinics

• special-appointed clinics

Patient-level exclusion criteria

• patients aged less than 18

• patients with active catastrophic illness or terminal malignancies

• patients with major adverse cardiac events within 3 months before the index dates

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Family Medicine
• Hypertension
• Preventive Medicine

Intervention

Diagnostic Test:
• Height, Weight, and Blood Pressure Measurement Procedures Improvement
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?"

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Home 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
Secondary	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
Secondary	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
Secondary	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