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

10 augusti 2026 uppdaterad av: 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 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?

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

150

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60617
        • Rekrytering
        • Advocate Medical Group Chicago (Southeast)
        • Kontakt:
      • Chicago, Illinois, Förenta staterna, 60619
        • Rekrytering
        • Advocate Medical Group Chicago (Imani Village)
        • Kontakt:
      • Chicago, Illinois, Förenta staterna, 60643
        • Rekrytering
        • Advocate Medical Group Beverly
        • Kontakt:
      • Merrionette Park, Illinois, Förenta staterna, 60803
        • Rekrytering
        • Advocate Medical Group Merrionette Park
        • Kontakt:
      • Oak Lawn, Illinois, Förenta staterna, 60453
        • Rekrytering
        • Advocate Medical Group Oak Lawn (IM)
        • Kontakt:
      • Oak Lawn, Illinois, Förenta staterna, 60453
        • Rekrytering
        • Advocate Medical Group Oak Lawn (FP)
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Mail-order cuff delivery - Enhanced Return Conversation
Patients will receive a blood pressure cuff in the mail and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team.
Beteende: Mail 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.
Aktiv komparator: Mail-order cuff delivery - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team.
Beteende: 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 - Enhanced Return Conversation
Patients will receive a blood pressure cuff in the clinic and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team.
Beteende: In-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.
Aktiv komparator: In-clinic cuff distribution - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of Blood Pressure Receipt
Tidsram: 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 Cuff Order Completion
Tidsram: 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
Rate of Return Modality Completion
Tidsram: up to day 14
Number of participants that completed the assigned return modality as documented on the envelope checklist.
up to day 14

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Complete Intervention
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
up to day 14
Rate of Fidelity
Tidsram: 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.
up to day 14
Rate of Differential Implementation Success
Tidsram: up to day 14
Number of participants with successful delivery of both blood pressure cuff and return modality.
up to day 14

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Systolic Blood Pressure
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Wake Forest University Health Sciences

Utredare

  • Huvudutredare: Rasha Khatib, PhD, Advocate Health

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 juli 2026

Primärt slutförande (Beräknad)

20 oktober 2026

Avslutad studie (Beräknad)

20 november 2026

Studieregistreringsdatum

Först inskickad

2 juli 2026

Först inskickad som uppfyllde QC-kriterierna

2 juli 2026

Första postat (Faktisk)

9 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 augusti 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00151173

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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