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

Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial

The goal of this study is to identify what cuff delivery and training strategies most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Mail Order Cuff Delivery - Hands-on Training; Behavioral: Mail Order Cuff Delivery - Written Instructions; Behavioral: In-Clinic Cuff Delivery - Hands-on Training; Behavioral: In-Clinic Cuff Delivery - Written Instructions

Detailed Description

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 hands-on training
2. Mail-order cuff delivery with written instructions
3. In-clinic cuff distribution with hands-on training
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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rasha Khatib, PhD; Phone Number: 7086843691; Email: Rasha.Alkhatib@aah.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60617
      • Advocate Medical Group Chicago 2301 93rd (Southeast)
      • Contact: Nicole Glowacki, MPH; Phone Number: 708-684-3691; Email: nicole.glowacki@aah.org
    • Chicago, Illinois, United States, 60619
      • Advocate Medical Group Chicago (Imani Village)
      • Contact: Nicole Glowacki, MPH; Phone Number: 708-684-3691; Email: nicole.glowacki@aah.org
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Medical Group Oak Lawn
      • Contact: Nicole Glowacki, MPH; Phone Number: 708-684-3691; Email: nicole.glowacki@aah.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mail-order cuff delivery - Hands-on training; Patients will receive a blood pressure cuff in the mail and receive hands on training.	Behavioral: Mail Order Cuff Delivery - Hands-on Training; Complete vendor form; provide blood pressure log/instructions; demonstrate self-measured blood pressure using sample cuff; submit vendor form for mail delivery; complete envelope checklist.
Active Comparator: Mail-order cuff delivery - Written instructions; Patients will receive a blood pressure cuff in the mail and receive written training.	Behavioral: Mail Order Cuff Delivery - Written Instructions; Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.
Active Comparator: In-clinic cuff distribution - Hands-on training; Patients will receive a blood pressure cuff in the clinic and receive hands on training.	Behavioral: In-Clinic Cuff Delivery - Hands-on Training; Complete vendor form; provide blood pressure log/instructions; demonstrate self-measured blood pressure using sample cuff; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.
Active Comparator: In-clinic cuff distribution - Written instructions; Patients will receive a blood pressure cuff in the mail and receive written training.	Behavioral: In-Clinic Cuff Delivery - Written Instructions; Complete vendor form; provide blood pressure log/instructions; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Blood Pressure Receipt	Number of participants that have received their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available	up to day 14
Rate of Training Completion	Number of participants that completed the assigned training modality as documented on the envelope checklist.	up to day 14
Rate of Cuff Order Completion	Number of participants that have ordered their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available.	up to day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Complete Intervention	Number of days from index clinic visit to documentation of both cuff receipt and completion of assigned training modality.	up to day 14
Number of Participants Documenting at Least One Blood Pressure Reading	Number of participants with at least one self-monitored blood pressure reading documented in the EHR within 21 days of cuff receipt.	up to day 21
Time Between Cuff Receipt and First Documented Reading	Number of days between cuff receipt and first documented self-monitored blood pressure reading.	up to day 21
Rate of Workflow Barriers	Number of participants with documented workflow barriers contributing to incomplete or non-concordant intervention delivery, including shipment issues, incomplete vendor forms, patient decline after workflow initiation, training not completed, missing documentation, clinic cuff inventory depletion, supply limitations, or other workflow disruptions identified through routine workflow documentation or operational follow-up activities.	up to day 14
Rate of Fidelity	Number of participants that received the assigned cuff delivery modality and assigned training modality without crossover, reassignment, or missing assigned workflow components.	up to day 14
Rate of Differential Implementation Success	Number of participants with successful delivery of both blood pressure cuff and training.	up to day 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure	Change in systolic blood pressure using routinely documented clinic blood pressure values in Epic.	up to day 90
Rate of Medication Intensification	Number of participants with addition of a new antihypertensive medication class, dose increase, or regimen intensification consistent with clinician-directed care using Epic medication order data.	up to day 90

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Rasha Khatib, PhD, Advocate Health

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: blood pressure cuff; blood pressure cuff delivery; blood pressure cuff instruction
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: IRB00151173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No