Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: In-Clinic Cuff Delivery - Hands-on Training, In-Clinic Cuff Delivery - Written Instructions, Mail Order Cuff Delivery - Hands-on Training, Mail Order Cuff Delivery - Written Instructions.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial
Overview
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?
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.
Interventions
- 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. - 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. - 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. - Behavioral Mail Order Cuff Delivery - Written Instructions
Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.
Primary outcome measures
- Rate of Blood Pressure Receipt [Time frame: up to day 14]
- Rate of Training Completion [Time frame: up to day 14]
- Rate of Cuff Order Completion [Time frame: up to day 14]
Secondary outcome measures (6)
- Time to Complete Intervention [Time frame: up to day 14]
- Number of Participants Documenting at Least One Blood Pressure Reading [Time frame: up to day 21]
- Time Between Cuff Receipt and First Documented Reading [Time frame: up to day 21]
- Rate of Workflow Barriers [Time frame: up to day 14]
- Rate of Fidelity [Time frame: up to day 14]
- Rate of Differential Implementation Success [Time frame: up to day 14]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 6 centers
- Advocate Medical Group Chicago (Southeast) — Chicago
- Advocate Medical Group Chicago (Imani Village) — Chicago
- Advocate Medical Group Beverly — Chicago
- Advocate Medical Group Merrionette Park — Merrionette Park
- Advocate Medical Group Oak Lawn (FP) — Oak Lawn
- Advocate Medical Group Oak Lawn (IM) — Oak Lawn
Identifiers
NCT: NCT07693699 · IRB00151173