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Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care

2. juli 2026 opdateret af: Wake Forest University Health Sciences

Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial

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?

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60617
        • Advocate Medical Group Chicago 2301 93rd (Southeast)
        • Kontakt:
      • Chicago, Illinois, Forenede Stater, 60619
        • Advocate Medical Group Chicago (Imani Village)
        • Kontakt:
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Advocate Medical Group Oak Lawn
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Mail-order cuff delivery - Hands-on training
Patients will receive a blood pressure cuff in the mail and receive hands on training.
Adfærdsmæssigt: 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.
Aktiv komparator: Mail-order cuff delivery - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training.
Adfærdsmæssigt: Mail Order Cuff Delivery - Written Instructions
Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.
Aktiv komparator: In-clinic cuff distribution - Hands-on training
Patients will receive a blood pressure cuff in the clinic and receive hands on training.
Adfærdsmæssigt: 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.
Aktiv komparator: In-clinic cuff distribution - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Blood Pressure Receipt
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Complete Intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: up to day 14
Number of participants with successful delivery of both blood pressure cuff and training.
up to day 14

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Systolic Blood Pressure
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wake Forest University Health Sciences

Efterforskere

  • Ledende efterforsker: Rasha Khatib, PhD, Advocate Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. juli 2026

Primær færdiggørelse (Anslået)

20. oktober 2026

Studieafslutning (Anslået)

20. november 2026

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00151173

Plan for individuelle deltagerdata (IPD)

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