TrialPath
Recruiting

Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care

NCT07693699 · Wake Forest University Health Sciences
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial
About this study
The study team developed a clinical integration package as a multicomponent primary care-based approach to increase SMBP adoption through structured workflows, patient training, blood pressure logs, reminders/support, and clinical follow-up. Pilot work demonstrated that SMBP uptake can be significantly improved in underserved primary care settings. However, the pilot relied on research funds to purchase cuffs, which is not sustainable for health-system scale. A scalable model must identify practical pathways for patients to obtain standard validated blood pressure cuffs through routine care mechanisms, including vendor-supported, insurance-billed, consignment, or mail-order pathways, without depending on research-purchased devices. In addition to cuff access, effective SMBP implementation also requires feasible approaches to patient training. Many patients do not receive standardized instruction on how to correctly measure and record home blood pressure readings, and intensive in-person training models may be difficult to sustain in routine primary care workflows. Health systems therefore need practical training strategies that balance effectiveness with scalability, ranging from brief hands-on education delivered during clinic visits to lower-touch written or self-guided educational materials. Patients will be randomized to one of four arms: 1. Mail-order cuff delivery with enhanced return conversation 2. Mail-order cuff delivery with written instructions 3. In-clinic cuff distribution with enhanced return conversation 4. In-clinic cuff distribution with written instructions All other intervention components will be standardized across study arms, including receipt of a blood pressure log, written instructions on when and how to obtain home blood pressure readings, and routine clinic processes for documenting or reviewing SMBP readings returned by patients. The design is intended to evaluate implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself. This design is intended to evaluate operational implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself.
Eligibility criteria
Inclusion Criteria: * Age 18 years or older. * Diagnosed hypertension documented prior to the index clinic visit. * Scheduled for and attends an in-person visit with a participating clinician at a study clinic. * Elevated BP (blood pressure) documented in Epic during rooming or the clinic visit before study enrollment, defined as systolic BP \>=140 mmHg or diastolic BP \>=90 mmHg. Exclusion Criteria: * Visit is canceled, rescheduled, or the patient does not attend the visit. * Patient already has a usable home BP cuff provide through insurance within the past 5 years. * Patient declines assistance obtaining a BP cuff. * Patient declines submitting cuff order to insurance. * Patient unable to participate for operational reasons.
Study design
Enrollment target: 150 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-30
Estimated completion: 2026-11-20
Last updated: 2026-08-12
Interventions
Behavioral: In-Clinic Cuff Delivery - Enhanced Return ConversationBehavioral: In-Clinic Cuff Delivery - Written InstructionsBehavioral: Mail Order Cuff Delivery - Enhanced Return ConversationBehavioral: Mail Order Cuff Delivery - Written Instructions
Primary outcomes
  • Rate of Blood Pressure Receipt (up to day 14)
  • Rate of Return Modality Completion (up to day 14)
  • Rate of Cuff Order Completion (up to day 14)
Sponsor
Wake Forest University Health Sciences · other
Contacts & investigators
ContactRasha Khatib, PhD · contact · Rasha.Alkhatib@aah.org · 7086843691
InvestigatorRasha Khatib, PhD · principal_investigator, Advocate Health
All locations (6)
Advocate Medical Group Chicago (Southeast)Recruiting
Chicago, Illinois, United States
Advocate Medical Group Chicago (Imani Village)Recruiting
Chicago, Illinois, United States
Advocate Medical Group BeverlyRecruiting
Chicago, Illinois, United States
Advocate Medical Group Merrionette ParkRecruiting
Merrionette Park, Illinois, United States
Advocate Medical Group Oak Lawn (FP)Recruiting
Oak Lawn, Illinois, United States
Advocate Medical Group Oak Lawn (IM)Recruiting
Oak Lawn, Illinois, United States
Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care · TrialPath