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Идёт набор NCT07232017

Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic

Наблюдательное Hypertension (HTN)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: IN-HOME BP.
Кому может быть актуально
Состояния в реестре: Hypertension (HTN). Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The primary objective of the Implementation of Effective Hypertension Management Approaches: Cleveland Clinic program is to improve blood pressure control for patients diagnosed with hypertension (HTN) and uncontrolled blood pressure, specifically defined as a blood pressure greater than 150/95, across all Cleveland Clinic Northeast Ohio primary care practices. The project will scale up the availability of resources for treating hypertension in 56 primary care practices within the Cleveland Clinic Health System in Northern Ohio, reaching up to approximately 3800 patients. This project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.

Подробное описание

Primary care providers will offer the program to patients in Northeast Ohio with a hypertension diagnosis and aged 18-85, except those who are pregnant, have stage 5 chronic kidney disease or end stage renal disease, or enrolled in hospice care. The project time frame is 48 months. Quantitative and qualitative methods will be used to evaluate implementation and effectiveness outcomes associated with the program. Electronic medical records and surveys will be the key data sources for the quantitative evaluation. Qualitative data collection methods will include semi-structured interviews, field observations, and periodic reflections.

Specific Aims Aim 1. To prepare for implementation of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Pre-Implementation) Pre-Implementation Phase (12 months)

* Quantitative assessment of practice variation in HTN control. * Qualitative assessment of practice barriers and facilitators to HTN management. * Creation of a clinical decision support tool for program referral. * Creation of project-specific patient and employee Advisory Panel. * Pharmacist and advanced practice provider (APP) training for delivery of the program. * Practice facilitation training with the Cleveland Clinic continuous improvement team. * Community Health Worker/Primary Care Navigator Training for Patient Outreach. * Creation of presentations for primary care staff meetings. Aim 2. To implement the intensive HTN management program across all Northeast Ohio Primary Care Practices (Rollout and Active Implementation) Implementation Phase (24 months) * Stepped wedge rollout of intensive HTN management program. * Implementation of the clinical decision support tool at implementation sites. * Community Health Worker/Primary Care Navigator outreach to patients. * Delivery of Presentations at primary care staff meetings. * Practice Facilitation at Implementation Sites. * Qualitative data collection regarding patient and provider implementation outcomes of acceptability and feasibility. * Quantitative data collection of implementation outcomes of adoption, fidelity, effectiveness, implementation cost; provider surveys re: acceptability, appropriateness, feasibility. * Patient and employee advisory panel input into implementation evaluation. Aim 3. To monitor and evaluate the maintenance of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Maintenance) Maintenance Phase (9 months) * Quantitative data collection of implementation outcomes-reach, adoption, fidelity, effectiveness, cost-compared to the active implementation phase. * Capture practice-level adaptations with comparison to the active implementation phase. * Complete final data collection and analyses.

Вмешательства

  • Другое IN-HOME BP
    A team-based approach with a primary care provider (PCP) collaborating with pharmacists and advanced practice providers (APP) and will use a mechanism (frequent follow-up- phone or virtual appointments) that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.

Первичные конечные точки

  • Systolic Blood Pressure Change [Срок оценки: Patients will be followed for up to 33 months: 24-month implementation/intervention period and 9-month maintenance period.]
Вторичные конечные точки (12)
  • Diastolic Blood Pressure Change [Срок оценки: The patient's blood pressure will be measured for up to 33 months (24-month implementation/intervention period and 9-month maintenance period). Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance.]
  • Reach (Actual): Patients Offered, Initiated, Completed [Срок оценки: Measured every 3 months for up to 33 months.]
  • Effectiveness: Equity in Outcomes (Race) [Срок оценки: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.]
  • Effectiveness: Equity in Outcomes (Ethnicity) [Срок оценки: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.]
  • Effectiveness: Equity in Outcomes (Gender) [Срок оценки: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.]
  • Effectiveness: Equity in Outcomes (Age) [Срок оценки: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.]
  • Effectiveness: Equity in Outcomes (Insurance) [Срок оценки: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.]
  • Effectiveness: Medication change [Срок оценки: Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.]
  • Effectiveness: Medication Adherence [Срок оценки: Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.]
  • Effectiveness: Cardiovascular outcomes [Срок оценки: Baseline, and every 6 months through maintenance: for up to 33 months.]
  • Effectiveness: Acute Renal Failure - Change in glomerular filtration rate (GFR). [Срок оценки: Every 6 months through maintenance: for up to 33 months.]
  • Effectiveness: PROMIS-10 Survey [Срок оценки: Baseline at intake visit then at 12 months: up to 24-months.]

Критерии участия

Критерии включения

  • Hypertension diagnosis, aged 18-85 years old
  • Uncontrolled blood pressure, defined as a blood pressure reading of > 150/95

Критерии исключения

  • pregnant, stage 5 chronic kidney disease, End Stage Renal Disease, enrolled in hospice care

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Cleveland Clinic — Cleveland

Публикации

  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. PMID 28851459
  • Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19. PMID 19543809
  • Margolis KL, Bergdall AR, Crain AL, JaKa MM, Anderson JP, Solberg LI, Sperl-Hillen J, Beran M, Green BB, Haugen P, Norton CK, Kodet AJ, Sharma R, Appana D, Trower NK, Pawloski PA, Rehrauer DJ, Simmons ML, McKinney ZJ, Kottke TE, Ziegenfuss JY, Williams RA, O'Connor PJ. Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Clu PMID 36281763

Идентификаторы

NCT: NCT07232017 · 25-792

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗