Hypertension
Conditions
Keywords
blood pressure cuff, blood pressure cuff delivery, blood pressure cuff instruction
Brief summary
The goal of this study is to identify what cuff delivery and BP log return modality 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 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.
Interventions
BEHAVIORALIn-Clinic Cuff Delivery - Enhanced Return Conversation
Complete vendor form; provide blood pressure log/instructions; discuss with patient how and when to return bp log; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.
BEHAVIORALIn-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.
BEHAVIORALMail Order Cuff Delivery - Enhanced Return Conversation
Complete vendor form; provide blood pressure log/instructions; discuss with patient how and when to return bp log; submit vendor form for mail delivery; complete envelope checklist.
BEHAVIORALMail Order Cuff Delivery - Written Instructions
Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Blood Pressure Receipt | up to day 14 | Number of participants that have received their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available |
| Rate of Return Modality Completion | up to day 14 | Number of participants that completed the assigned return modality as documented on the envelope checklist. |
| Rate of Cuff Order Completion | up to day 14 | Number of participants that have ordered their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Intervention | up to day 14 | Number of days from index clinic visit to documentation of both cuff receipt and completion of assigned training modality. |
| Number of Participants Documenting at Least One Blood Pressure Reading | up to day 21 | Number of participants with at least one self-monitored blood pressure reading documented in the EHR within 21 days of cuff receipt. |
| Time Between Cuff Receipt and First Documented Reading | up to day 21 | Number of days between cuff receipt and first documented self-monitored blood pressure reading. |
| Rate of Workflow Barriers | up to day 14 | 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, return modality not completed, missing documentation, clinic cuff inventory depletion, supply limitations, or other workflow disruptions identified through routine workflow documentation or operational follow-up activities. |
| Rate of Fidelity | up to day 14 | Number of participants that received the assigned cuff delivery modality and assigned return modality without crossover, reassignment, or missing assigned workflow components. |
| Rate of Differential Implementation Success | up to day 14 | Number of participants with successful delivery of both blood pressure cuff and return modality. |
Countries
United States
Contacts
CONTACTRasha Khatib, PhD
PRINCIPAL_INVESTIGATORRasha Khatib, PhD
Advocate Health
Outcome results
None listed