Automatically Transmitted Home Blood Pressure and Automated Patient Feedback in Hypertension Care: the AUTO 2 Trial

Официальное название

Effects of Manually Recorded or Automatically Transmitted Home Blood Pressures With or Without Automated Patient Feedback on Hypertension Care

Обзор

The purpose of this study is to evaluate the effectiveness of automatically-generated medical advice to patients about to their home blood pressure monitoring results sent through patient portal messages compared to no automated advice and the effectiveness of automated transmission of remotely-obtained blood pressure values compared to self-reported values on systolic blood pressure at 1-year follow up in patients with uncontrolled hypertension whose physicians or advance practice providers provide primary care at Northwestern Medicine. Persistence of effects through 18 months will also be assessed.

Вмешательства

• Другое Self report of home measured blood pressure via patient EHR portal
  Participants will be provided with a home blood pressure monitor and method to use the EHR portal to enter home collected blood pressures into the EHR.
• Другое Automated feedback about home blood pressure results
  Patients will received periodic messages about the results of their home blood pressure monitoring with suggestions to consult with clinical care team when indicated.
• Другое Automated Transmission of Remotely Measured Blood Pressure
  Participants will be provided with a blood pressure monitor and application to automatically transmit home blood pressures to their EHR record.

Первичные конечные точки

• Systolic blood pressure at 12 months [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Systolic blood pressure at 18 months [Срок оценки: 18 months]
• Antihypertensive medication changes from baseline [Срок оценки: From baseline to 12 months and 18 months]
• Antihypertensive medication classes prescribed, standardized count [Срок оценки: 12 months and 18 months]
• Medication adherence (patient report, Domains of Subjective Extent of Nonadhernece) [Срок оценки: 12 months and 18 months]
• Diastolic blood pressure [Срок оценки: 12 months and 18 months]
• Blood pressure <130/80 mm Hg [Срок оценки: 12 months and 18 months]
• Blood pressure <140/90 mm Hg [Срок оценки: 12 months and and 18 months]

Критерии участия

Критерии включения

• Age 18-84 years at enrollment date
• Receives hypertension care primarily from a participating clinician
• Blood pressure on the two most recent days when ambulatory clinic blood pressure was obtained prior to patient identification to was ≥140 mm Hg systolic and/or ≥90 diastolic or last ambulatory clinic blood pressure was ≥150 mm Hg systolic and/or ≥95 diastolic
• Currently has or is willing to obtain a patient portal account from NM.

Критерии исключения

• Dementia,
• Nursing home resident,
• Stage 5 chronic kidney disease or renal replacement therapy,
• Pregnancy,
• Receiving hospice,
• Not planning to continue to receive hypertension care from NM clinician for the next year,
• Planning to move from the region in the next year,
• Planning to change clinician treating their hypertension in the next year,
• Medical or psychological reason they cannot perform home blood pressure monitoring.
• Known to have average home blood pressure or most recent home blood pressure value of <130/80 mm Hg.

CLINICIAN PARTICIPANT INCLUSION Physician, advanced practice nurse or physician assistant working at a Northwestern Medicine ambulatory primary care site that cares for adults with hypertension (family medicine, internal medicine, medicine/pediatrics, and ambulatory geriatrics sites).

CLINICIAN PARTICIPANT EXCLUSION

• Primary care physicians and clinicians not willing for their patients to participate in study
• Planning to depart NM within the next year
• Not willing to receive patients' out-of-office blood pressure data

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Northwestern University Feinberg School of Medicine — Chicago

Публикации

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Идентификаторы

NCT: NCT07397260 · STU00224615 · R01HL179919

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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