Effects of Facilitating On-Site Recordings of Office Blood Pressure, Height, and Weight on Preventive Medicine - A Pragmatic Cluster Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 800
- Locations
- 2
- Primary Endpoint
- Rate of Newly-Diagnosed Diabetes Mellitus
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
Arms & Interventions
No Intervention Group
This group does not specifically encourage or interfere with physicians' original methods of inquiry or patients providing bodily examination data.
Intervention Group
This group encourages physicians to actively inquire or patients to voluntarily provide physical examination data during consultations.
Intervention: Height, Weight, and Blood Pressure Measurement Procedures Improvement (Diagnostic Test)
Outcomes
Primary Outcomes
Rate of Newly-Diagnosed Diabetes Mellitus
Time Frame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Assessing whether the improvement in documentation of on-site blood pressure, height, and weight recordings increases the diagnosis rates of diabetes mellitus.
Proportion of Participants with Documented On-Site Blood Pressure, Height, and Weight Recordings
Time Frame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
The documentation of on-site blood pressure, height, and weight recordings
Rate of Newly-Diagnosed Hypertension
Time Frame: From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward
Assessing whether the improvement in documentation of on-site blood pressure, height, and weight recordings increases the diagnosis rates of hypertension.
Secondary Outcomes
- Urinary Microalbumin Excretion(From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward)
- Home Blood Pressure in Hypertensionsive Patients(From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward)
- Estimated Glomerular Filtration Rate(From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward)
- Office Blood Pressure in Hypertensionsive Patients(From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward)
- Mortality Rate(From date of randomization until the date of first documented progression, assessed up to 36 months)