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
Přehled studie
Postavení
Podmínky
Detailní popis
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:
- Mail-order cuff delivery with hands-on training
- Mail-order cuff delivery with written instructions
- In-clinic cuff distribution with hands-on training
- 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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Rasha Khatib, PhD
- Telefonní číslo: 7086843691
- E-mail: Rasha.Alkhatib@aah.org
Studijní místa
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60617
- Advocate Medical Group Chicago 2301 93rd (Southeast)
-
Kontakt:
- Nicole Glowacki, MPH
- Telefonní číslo: 708-684-3691
- E-mail: nicole.glowacki@aah.org
-
Chicago, Illinois, Spojené státy, 60619
- Advocate Medical Group Chicago (Imani Village)
-
Kontakt:
- Nicole Glowacki, MPH
- Telefonní číslo: 708-684-3691
- E-mail: nicole.glowacki@aah.org
-
Oak Lawn, Illinois, Spojené státy, 60453
- Advocate Medical Group Oak Lawn
-
Kontakt:
- Nicole Glowacki, MPH
- Telefonní číslo: 708-684-3691
- E-mail: nicole.glowacki@aah.org
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Mail-order cuff delivery - Hands-on training
Patients will receive a blood pressure cuff in the mail and receive 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.
|
|
Aktivní komparátor: Mail-order cuff delivery - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training.
|
Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.
|
|
Aktivní komparátor: In-clinic cuff distribution - Hands-on training
Patients will receive a blood pressure cuff in the clinic and receive 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.
|
|
Aktivní komparátor: In-clinic cuff distribution - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training.
|
Complete vendor form; provide blood pressure log/instructions; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Rate of Blood Pressure Receipt
Časové okno: 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
|
up to day 14
|
|
Rate of Training Completion
Časové okno: up to day 14
|
Number of participants that completed the assigned training modality as documented on the envelope checklist.
|
up to day 14
|
|
Rate of Cuff Order Completion
Časové okno: 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.
|
up to day 14
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to Complete Intervention
Časové okno: up to day 14
|
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
Časové okno: 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.
|
up to day 21
|
|
Time Between Cuff Receipt and First Documented Reading
Časové okno: up to day 21
|
Number of days between cuff receipt and first documented self-monitored blood pressure reading.
|
up to day 21
|
|
Rate of Workflow Barriers
Časové okno: 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, 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
Časové okno: up to day 14
|
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
Časové okno: up to day 14
|
Number of participants with successful delivery of both blood pressure cuff and training.
|
up to day 14
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Systolic Blood Pressure
Časové okno: up to day 90
|
Change in systolic blood pressure using routinely documented clinic blood pressure values in Epic.
|
up to day 90
|
|
Rate of Medication Intensification
Časové okno: up to day 90
|
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
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Rasha Khatib, PhD, Advocate Health
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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