Effects of FOR-Care Model on Preventive Medicine

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Diabetes Mellitus; Body Weight; Preventive Medicine; Family Medicine
• Intervention / Treatment: Diagnostic test: Height, Weight, and Blood Pressure Measurement Procedures Improvement

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention Group; This group does not specifically encourage or interfere with physicians' original methods of inquiry or patients providing bodily examination data.
Experimental: Intervention Group; This group encourages physicians to actively inquire or patients to voluntarily provide physical examination data during consultations.	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?"; Other Names: FOR-Care Model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Chien-Hsieh Chiang, MD, MPH, PhD, Family MedicineClinical Assistant Professor, Department of Family Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 28, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cluster randomized trial; Diabetes mellitus; Body weight; Preventive medicine; Family medicine; Outpatient department
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Body Weight; Diabetes Mellitus
• Other Study ID Numbers: 202402048RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: However, de-identified data regarding the pre-defined outcomes or relevant characteristics could be available per request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No