跳至主要内容
临床试验/NCT03713515
NCT03713515已完成4 期

Bridging the Evidence-to-practice Gap: Evaluating Practice Facilitation as a Strategy to Accelerate Translation of a Systems-level Adherence Intervention Into Safety Net Practices

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 652 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
652
试验地点
1
主要终点
Level of implementation fidelity

研究概览

简要总结

The proposed project will address this evidence-to-practice gap by evaluating the effect of practice facilitation (PF) of the intervention implementation fidelity (primary outcome) and clinical measures at 12 months (secondary outcomes).

详细描述

Advancing Medication Adherence for Latinx with Hypertension through a Team-based Care Approach (ALTA) evaluates the effectiveness of using a quality improvement method called practice facilitation (PF) to implement our evidence-based systems-level intervention for improving medication adherence and blood pressure control.

The ALTA intervention focuses on identifying Latinx patients with uncontrolled hypertension who are non-adherent to their antihypertensive medication, referring them to health coaches, coaching patients on medication adherence and self-management, care planning, and monitoring patients to improve patient outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-identify as Latino
  • Be fluent in English or Spanish
  • Be age 18 years or older
  • Receiving care in a safety-net primary care practice
  • Have uncontrolled HTN documented in the electronic health record (EHR) on at least two visits in the past year (defined as an average BP ≥ 140/90 mmHg)
  • Have been prescribed at least one anti-hypertensive medication and be non- adherent to their medications, defined as adherence <80% in the preceding 12 months, as determined by prescription orders obtained from the clinic EHR.
  • Clinic and nonclinical staff inclusion criteria:
  • Primary care provider (MD/DO, NP), Nurse, Medical Assistant, or administrative staff employed at the participating practices and (b) interacts with at least five patients with a diagnosis of hypertension.

排除标准

  • Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
  • Participation in other hypertension-related clinical trials
  • Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
  • Plan to discontinue care at their practice within the next 12 months
  • Clinic and nonclinical staff exclusion criteria:
  • Refuse to participate

研究组 & 干预措施

Usual Care

No Intervention

Using a stepped wedge design, all practice sites begin as part of the Usual Care (UC) control condition and will receive standard hypertension management that is part of the current clinic procedure. No practice facilitation will occur at this time.

Practice Faciliation

Experimental

Will be supported by a practice facilitator

干预措施: ALTA (Behavioral)

结局指标

主要结局

Level of implementation fidelity

时间窗: 12 months

Implementation fidelity will be defined as the degree to which ALTA was delivered, as intended. A mixed methods approach will be used to assess the five core domains of implementation fidelity: (1) adherence to the program protocol; (2) dose of the program delivered; (3) quality of program delivery; (4) participant responsiveness; and (5) program differentiation.

次要结局

  • Medication adherence(12 months)
  • Blood Pressure (BP) control(Baseline and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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