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
Przegląd badań
Status
Warunki
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Rasha Khatib, PhD
- Numer telefonu: 7086843691
- E-mail: Rasha.Alkhatib@aah.org
Lokalizacje studiów
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-
Illinois
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Chicago, Illinois, Stany Zjednoczone, 60617
- Advocate Medical Group Chicago 2301 93rd (Southeast)
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Kontakt:
- Nicole Glowacki, MPH
- Numer telefonu: 708-684-3691
- E-mail: nicole.glowacki@aah.org
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Chicago, Illinois, Stany Zjednoczone, 60619
- Advocate Medical Group Chicago (Imani Village)
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Kontakt:
- Nicole Glowacki, MPH
- Numer telefonu: 708-684-3691
- E-mail: nicole.glowacki@aah.org
-
Oak Lawn, Illinois, Stany Zjednoczone, 60453
- Advocate Medical Group Oak Lawn
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Kontakt:
- Nicole Glowacki, MPH
- Numer telefonu: 708-684-3691
- E-mail: nicole.glowacki@aah.org
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: 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.
|
|
Aktywny komparator: 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.
|
|
Aktywny komparator: 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.
|
|
Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Rate of Blood Pressure Receipt
Ramy czasowe: 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
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up to day 14
|
|
Rate of Training Completion
Ramy czasowe: up to day 14
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Number of participants that completed the assigned training modality as documented on the envelope checklist.
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up to day 14
|
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Rate of Cuff Order Completion
Ramy czasowe: up to day 14
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Number of participants that have ordered their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available.
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up to day 14
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time to Complete Intervention
Ramy czasowe: 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
Ramy czasowe: up to day 21
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Number of participants with at least one self-monitored blood pressure reading documented in the EHR within 21 days of cuff receipt.
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up to day 21
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Time Between Cuff Receipt and First Documented Reading
Ramy czasowe: up to day 21
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Number of days between cuff receipt and first documented self-monitored blood pressure reading.
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up to day 21
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Rate of Workflow Barriers
Ramy czasowe: up to day 14
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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
Ramy czasowe: 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
Ramy czasowe: up to day 14
|
Number of participants with successful delivery of both blood pressure cuff and training.
|
up to day 14
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Systolic Blood Pressure
Ramy czasowe: up to day 90
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Change in systolic blood pressure using routinely documented clinic blood pressure values in Epic.
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up to day 90
|
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Rate of Medication Intensification
Ramy czasowe: up to day 90
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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
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Rasha Khatib, PhD, Advocate Health
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB00151173
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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