The REACH-OUT Trial

Официальное название

A Technology-based, Primary Care Strategy to Optimize Blood Pressure Before Pregnancy: The REACH-OUT Trial

Обзор

Test the effectiveness of a technology-enabled strategy to optimize blood pressure among reproductive-aged women with hypertension receiving care in Federally Qualified Health Centers.

Подробное описание

The investigator team has worked with the FQHC partners to co-develop a multicomponent, technology-based strategy to promote the REproductive And Cardiovascular Health Of Underserved Patients with HyperTension (REACH-OUT). Clinicians at participating study sites will receive EHR-based clinical decision support that facilitates review of prescribed antihypertensives (antiHTNs) and contraceptives to identify contraindications and prompts targeted counseling on medication safety, adherence, and BP for young women with hypertension (HTN). For patients in the intervention arm, REACH-OUT also provides \[1\] educational materials to reinforce clinician counseling, \[2\] a BP monitor, training, and access to a patient portal-based tool where home BP measures can be recorded, and \[3\] a brief, portal-based survey to assess antiHTN use and 'phenotype' causes of poor adherence for clinic review. For patients who have difficulty monitoring their BP and adherence at home, \[4\] a patient navigator will provide tailored support and help troubleshoot any challenges.

This study will test REACH-OUT vs. usual care in a patient-randomized trial. 350 English or Spanish-speaking, non-pregnant women on antiHTN therapy with elevated BP will be enrolled in the study. The study aims are to: 1) Test the effectiveness of REACH-OUT, compared to usual care, to lower systolic BP, improve antiHTN adherence, and reduce use of contraindicated medications within 3 months; 2) Assess the reach, adoption, implementation, maintenance, and costs of REACH-OUT components; and 3) Explore the dose-response effect of REACH-OUT on BP, antiHTN adherence, and use of contraindicated medications over 12 months.

Вмешательства

• Другое Health literacy-informed patient education materials
  Health literacy-informed patient education materials will be uploaded to the patient portal and/or sent to patients by mail, email, or text message. Materials will reinforce clinician counseling and describe the importance of antiHTN adherence and BP control specifically for young women with HTN. Materials will be delivered in English or Spanish based on the preferred language.
• Поведенческое BP monitor, brief orientation, and portal tools
  A care coordinator will be notified once a patient has enrolled. For each enrolled patient: 1) a clinic care coordinator will place an order for HBPM in the EHR. This will include a hypertension flowsheet that specifies BP criteria that will trigger a clinic alert; 2) The assigned primary care clinician will review and cosign the order after verifying the patient should not be excluded on medical grounds; 3) the patient will receive a BP monitor; 4) the patient will be contacted by the care coor
• Другое The MeDS assessment
  The MeDS is a brief survey to assess antiHTN use that 'phenotypes' root causes of poor adherence. Participants will take the survey at the end of the 7-day monitoring period; research staff will send participants the MeDS assessment via a MyChart message. This survey will only appear for enrolled patients and will only be completed once per monitoring period. An algorithm for determining which responses warrant clinic follow-up will be developed. Any flagged concern will appear in a report. Rese
• Другое Patient navigator support
  Any patient who has not initiated monitoring within 14 days of their orientation or has discontinued participation will be contacted by a clinic-based navigator, who will assess reasons for non-participation and help troubleshoot barriers. Navigators will use a structured script in Epic to identify, document, and address any barriers.

Первичные конечные точки

• Systolic blood pressure [Срок оценки: 3 months]

Вторичные конечные точки (4)

• Adherence to Refills and Medication Survey (ARMS) [Срок оценки: 3 months]
• Biochemical Adherence to Antihypertensive Medications [Срок оценки: 3 months]
• Pill Count Adherence to Antihypertensive Medications [Срок оценки: 3 months]
• Use of Contraindicated Medications [Срок оценки: 3 months]

Критерии участия

Критерии включения

• biologically female
• age 18-44
• English or Spanish-speaking
• prescribed an antiHTN
• have a systolic BP >140 or diastolic BP>90 at their index visit
• have access to the internet

Критерии исключения

• not pregnant or within 3 months postpartum
• severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Northwestern University — Chicago

Идентификаторы

NCT: NCT07540143 · STU00223582

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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