Clinical trial NCT06406192: Effects of FOR-Care Model on Preventive Medicine
Official title: Effects of Facilitating On-Site Recordings of Office Blood Pressure, Height, and Weight on Preventive Medicine - A Pragmatic Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Body Weight
Family Medicine
Hypertension
Preventive Medicine
Keywords: Body weight
Diabetes mellitus
Cluster randomized trial
Family medicine
Outpatient department
Preventive medicine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Participants with Documented On-Site Blood Pressure, Height, and Weight Recordings
timeFrame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
measure: Rate of Newly-Diagnosed Hypertension
timeFrame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
measure: Rate of Newly-Diagnosed Diabetes Mellitus
timeFrame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Secondary outcomes:
measure: Office Blood Pressure in Hypertensionsive Patients
timeFrame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
measure: Home Blood Pressure in Hypertensionsive Patients
timeFrame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
measure: Estimated Glomerular Filtration Rate
timeFrame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
measure: Urinary Microalbumin Excretion
timeFrame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
measure: Mortality Rate
timeFrame: From date of randomization until the date of first documented progression, assessed up to 36 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Family MedicineClinical Assistant Professor, Department of Family Medicine
name: Chien-Hsieh Chiang, MD, MPH, PhD
role: STUDY_CHAIR
References: