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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?
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mail-order cuff delivery - Hands-on training | Active Comparator | Patients will receive a blood pressure cuff in the mail and receive hands on training. |
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| Mail-order cuff delivery - Written instructions | Active Comparator | Patients will receive a blood pressure cuff in the mail and receive written training. |
|
| In-clinic cuff distribution - Hands-on training | Active Comparator | Patients will receive a blood pressure cuff in the clinic and receive hands on training. |
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| In-clinic cuff distribution - Written instructions | Active Comparator | Patients will receive a blood pressure cuff in the mail and receive written training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-Clinic Cuff Delivery - Hands-on Training | Behavioral | 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. |
| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rasha Khatib, PhD | Contact | 7086843691 | Rasha.Alkhatib@aah.org |
| Name | Affiliation | Role |
|---|---|---|
| Rasha Khatib, PhD | Advocate Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Medical Group Chicago 2301 93rd (Southeast) | Chicago | Illinois | 60617 | United States |
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| In-Clinic Cuff Delivery - Written Instructions | Behavioral | Complete vendor form; provide blood pressure log/instructions; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist. |
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| Mail Order Cuff Delivery - Hands-on Training | Behavioral | 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. |
|
| Mail Order Cuff Delivery - Written Instructions | Behavioral | Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist. |
|
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 |
| up to day 90 |
| Advocate Medical Group Chicago (Imani Village) | Chicago | Illinois | 60619 | United States |
|
| Advocate Medical Group Oak Lawn | Oak Lawn | Illinois | 60453 | United States |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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