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Northwestern University and Access Community Health Network Medication Education Study (NAMES)

2019年6月4日 更新者:Stephen Persell, MD, MPH、Northwestern University

EHR-based Health Literacy Strategy to Promote Medication Therapy Management

Many patients have difficulty performing routine medication management tasks. Individuals with limited literacy are at high risk for these problems. The overall study objective is to rigorously evaluate two primary care-based medication therapy management strategies that leverage an electronic health record (EHR) to promote patient understanding, medication reconciliation, medication adherence and disease control among hypertensive patients at safety net clinics.

調査の概要

詳細な説明

Medication therapy management (MTM) has been described as a set of procedures that include: medication review, assembly of a personal medication record, development of action plans, intervention when necessary, and follow-up. However, evidence showing the effectiveness of general MTM interventions is scant. MTM has often been performed separately from patients' usual sources of care (i.e., at pharmacies). This could limit its effectiveness since medication-related concerns would be discussed by clinicians who are not aware of the regimen intended by patients' prescribers. Cost is another barrier to widespread use of MTM.

Health information technology in primary care could be leveraged to assist with MTM tasks. The investigators have field tested low literacy MTM tools embedded within an EHR to 1) activate patients to review medications, 2) automate the provision of plain language, medication information, and 3) provide print tools to help patients engage providers, and consolidate their regime. These tools were developed with patient, physician, and pharmacist feedback.

For this study, the investigators combine tools to address the range of MTM tasks. In aggregate, the study refers to this as an Electronic health record-based Health literacy Medication therapy management Intervention, or 'EHMI'. The investigators will evaluate the effects of this approach among patients with uncontrolled hypertension treated in federally qualified health centers (FQHCs). This may be a relatively low-cost strategy ideal for safety net practices that use EHRs and whose patients may be at greater risk for limited literacy. It is also possible that the EHMI strategy may not result in a significant change. Therefore, the investigators will also evaluate using a nurse educator to help patients utilize EHMI tools, provide brief counseling, and track progress.

This three-arm, clinic-randomized, controlled trial conducted within a network of FQHCs will evaluate the EHMI and EHMI + Nurse Educator interventions compared to usual care. Recruited patients will be followed for 12 months. The investigators will test the impact of these two strategies on blood pressure levels, with an anticipated power to detect a 4 mm Hg difference in systolic blood pressure as the primary outcome. The investigators will also assess the impact on diastolic blood pressure, as well as HbA1c and LDL cholesterol control in the subgroup with diabetes. The investigators will determine the interventions' effects on: 1) medication understanding, 2) discrepancies, and 3) adherence. The investigators will specifically examine intervention effects among groups with different literacy levels. The investigators will also assess the fidelity and cost of the interventions to guide future dissemination efforts.

研究の種類

介入

入学 (実際)

920

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Illinois
      • Chicago、Illinois、アメリカ、60661
        • Access Community Health Network

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • age is 18 years or older
  • at least 3 medications are prescribed by their physician
  • standardized mean blood pressure measurement ≥130 mm Hg systolic or ≥ 80 mm Hg diastolic if they are diabetic or mean blood pressure measurement ≥ 135 mm Hg systolic or ≥ 85 mm Hg diastolic if they are not
  • a Mini-Cog Exam score of ≥ 3
  • the patient is the person primarily responsible for administering their medication
  • the patient does not intend to move or change their usual source of medical care during the next year.

Exclusion Criteria:

  • the patient's usual source of medical care is not a participating ACCESS Community Health Center
  • is non-English language speaking
  • does not meet mean blood pressure criteria
  • has a Mini-Cog Exam score of < 3
  • is not the person primarily responsible for administering medication
  • intends to move or change their usual source of medical care during the next year.
  • Is not prescribed at least 3 medications

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Standard Care
This arm will serve as a control group and will not receive any intervention.
実験的:EHMI
Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components, all leveraged by the Epic EHR platform (Verona, WI). The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.
The EHMI intervention consists of multiple components, all leveraged by the Epic EHR platform (Verona, WI). The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.
実験的:Nurse Educator + EHMI
This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Systolic Blood Pressure
時間枠:one year
The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.
one year

二次結果の測定

結果測定
メジャーの説明
時間枠
Effectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care.
時間枠:Baseline, 3 months, 6 months, 12 months

This will be assessed by measuring patient medication understanding, medication reconciliation, adherence, and health outcomes (diastolic blood pressure, and among the diabetic subgroup Hemoglobin A1c <8.0 and LDL Cholesterol <100).

Reported here: HbA1c <8 at 12 months. Full secondary outcomes have been published. Persell SD, Karmali KN, MD, Lazar D, Friesema EM, Lee JY, Rademaker A, Kaiser D, Eder M, French DD, Brown T, Wolf MS. Effect of electronic health record-based medication support and nurse-led medication therapy management on hypertension and medication self-management: a randomized clinical trial. JAMA Intern Med. 2018;178:1069-1077.

Baseline, 3 months, 6 months, 12 months
Effects of These Strategies by Patients' Literacy Skills
時間枠:Baseline, 3 months, 6 months,12 months

We will measure how the effects of the interventions vary based on the participants' literacy levels.

SBP at 12 months reported below.

Baseline, 3 months, 6 months,12 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Stephen Persell, MD, MPH、Northwestern University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年4月1日

一次修了 (実際)

2016年6月1日

研究の完了 (実際)

2016年6月1日

試験登録日

最初に提出

2012年4月12日

QC基準を満たした最初の提出物

2012年4月16日

最初の投稿 (見積もり)

2012年4月17日

学習記録の更新

投稿された最後の更新 (実際)

2019年6月28日

QC基準を満たした最後の更新が送信されました

2019年6月4日

最終確認日

2019年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • Medication Therapy Management
  • 1R01NR012745 (米国 NIH グラント/契約)

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