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Diabetes Interprofessional Team to Enhance Adherence to Medical Care (DM I-TEAM)

2022年10月18日 更新者:Barry Rovner、Thomas Jefferson University
The overall goal of this randomized controlled trial is to test the efficacy of DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care) to reduce emergency department (ED) visits and hospitalizations over 12 months in older African Americans (AAs) with diabetes mellitus (DM). DM I-TEAM is a multidisciplinary behavioral intervention that comprises a community health worker (CHW), the participant's primary care physician (PCP), a diabetes nurse educator, and a clinical geriatric pharmacist. In DM I-TEAM, the CHW conducts in-home sessions to: (1) provide diabetes education, (2) facilitate adherence to diabetes self-management behaviors (e.g., medication adherence glucose monitoring, diet, exercise); and (3) build trust between patients and their primary care team. This is accomplished by: (1) using culturally relevant diabetes educational materials; (2) facilitating telehealth visits with the participant's PCP and the diabetes nurse educator via JeffConnect; and (3) having the study pharmacist review participants' medication regimens to identify potentially inappropriate medications, simplify medication regimens if possible, and to reduce medication side effects.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

AAs have twice the rate of DM as Whites, and worse glycemic control, less optimal medication regimens, and less trust in the medical system. These disparities contribute to why AAs with DM are more likely to go blind, lose limbs, require dialysis, develop dementia, and die than Whites. These disparities, in turn, reflect racial differences in education, income, health literacy, cultural beliefs, experiences of discrimination, and social adversity, which can lead to: 1) poor glycemic control; 2) suboptimal medication use; and 3) mistrust in medical care. DM I-TEAM addresses these 3 factors, which often precipitate ED and hospital care, using a culturally relevant, multidisciplinary team treatment approach to reduce the need for high acuity medical care, and equip underserved AAs with DM with the knowledge and skill to gain the benefits of high quality medical care that is otherwise available to everyone. Our approach applies currently available treatment elements in a culturally-relevant way to create a more equitable health landscape. Our immediate goal is to engage a high-risk population in treatment that can be trusted; that recognizes the realities of their lives (e.g., financial insecurity); that improves the quality of the medication they take, and that builds their self-efficacy to manage DM. The intermediate goal is to prevent untoward medical events that necessitate ED or hospital care. The long-term goal is to reverse the pernicious racial disparities that now characterize healthcare in the U.S. DM I-TEAM can achieve these goals by getting the right care to the right patient at the right time. DM I-TEAM is the right care because its leverages existing resources in a new way to improve health outcomes in AAs with DM. AAs with DM are the right patients because many have poorly controlled DM, take suboptimal medications, and face treatment barriers, often social in nature. Now is the right time, as the population becomes more racially diverse, healthcare costs increase, and demand for safety, quality, and value intensify. In these ways DM I-TEAM is right for American healthcare, bringing us closer to Healthy People 2020's twin goals of reducing the personal and societal costs of DM, and achieving health equity for all.

DM I-TEAM takes a dynamic team approach to diabetes management whereby the primary care physician, the study pharmacist, the diabetes educator, and the CHW collaborate to build patient trust, encourage diabetes self-management, and optimize medication regimens. Each member of the team plays a pivotal role in identifying important information that prevents effective diabetes management, and then works together to provide multi-layered support to patients. The roles of each team member are as follows:

CHW: The CHW extends clinic-based care into participants' homes to strengthen patient/provider relationships, customize diabetes education, and develop tailored treatment plans. The CHW facilitates telemedicine visits with the PCP and diabetes educator to build trust in the health care system by increasing participants' access to their care team. The quality and content of these visits is enhanced by CHW-provided information about the participant's life situation (e.g., family circumstances, barriers to optimal diabetes self-management, home environment), and current self-management practices and beliefs. There will be 6 90 minute in-home CHW sessions within 3 months of randomization (telemedicine sessions will occur during 3 of these visits). Booster sessions will occur 5, 7, and 11 months after randomization. During these visits, the CHW will (1) reinforce the diabetes treatment plan articulated by the PCP, (2) gather information regarding barriers to diabetes self-management behaviors and communicate them to the team; (3) inform the team of the participant's health-related questions/issues; (4) provide culturally-relevant diabetes education using appropriate educational materials; (5) work with the participant to formulate and execute diabetes Action Plans using the principles of Behavioral Activation (BA); and (6) communicate the participant's progress with their Action Plans to the team. BA is a behavioral technique based on reinforcement theory that is used to help people overcome avoidant tendencies through goal setting, activity scheduling, and graded task assignment. BA was originally developed to treat depression. Our research has demonstrated that BA can successfully facilitate diabetes self-management. The DM I-TEAM treatment manual (which is already developed but will be refined during the study start-up phase) describes each session in detail, and includes scripts and didactics for the CHW interventionist. The manual is not included in this grant submission due to space limitations. At each session, the CHW educates participants to contact the ED (either by phone or by patient portal) prior to presenting for services. Participants are given "emergency kits" that contain glucometers and related supplies and glucose tablets. The ED physician may recommend that participant's test their glucose and treat hypoglycemia prior to or instead of reporting to the ED.

PCP: The PCP provides diabetes care as per standard practice, but care is supplemented with input from the pharmacist and the CHW, and with telemedicine visits. The PCP optimizes medication regimens based on pharmacist recommendations. As the course of treatment progresses, the PCP reinforces Action Plans with the participant during clinic visits.

Pharmacist: With information gathered by the CHW and from the participant's electronic medical records (EMR), the pharmacist performs a comprehensive evaluation of the participant's medications to identify medications that are contraindicated in older patients, are not being taken as prescribed, are being taken incorrectly, are improperly dosed, or may be causing undesirable side effects. Based on her assessment, the pharmacist may recommend that the PCP modify the current medication regimen.

Diabetes Educator: The diabetes educator provides telemedicine visits to supplement diabetes education provided by the CHW, answer participants' questions, and reinforce medication adherence.

研究の種類

介入

入学 (実際)

200

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

    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19107
        • Thomas Jefferson University

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

35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:

  1. African American race
  2. Age ≥ 35 years; When first proposed the age criterion was 60 or older; it was later modified to 35 and older
  3. Type 1 or 2 DM
  4. A DM-related cause for the ED visit (i.e., hyperglycemia/hypoglycemia, diabetic ketoacidosis, chest pain, skin or soft tissue infection, diabetic neuropathy, retinopathy, urinary tract infection/pyelonephritis/acute renal injury, requesting DM medication refill) OR an hemoglobin A1c of 7.0% or greater within the past 30 days

Exclusion Criteria:

  1. Evidence of cognitive and functional decline suggestive of dementia.
  2. Anti-dementia medication use
  3. Life expectancy less than one year (in the opinion of the evaluating ED physician)
  4. DSM-V psychiatric disorders other than anxiety or depression (as per EMR)
  5. Intoxicated
  6. Suicidal
  7. In police custody or currently incarcerated
  8. Undergoing medical clearance for a detox center or any involuntary court or magistrate order
  9. Lives in assisted living, currently in a rehabilitation facility (other than Jefferson), lives in a nursing home or skilled nursing facility
  10. Pregnant

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:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:DM I-TEAM
DM I-TEAM is a home-based behavioral intervention that involve 9 treatment visits with a community health worker (CHW) over 12 months. During the treatment visits, the CHW provides culturally-relevant diabetes education, and facilitates telehealth visits with a diabetes nurse educator and participants' primary care physicians (PCPs). In addition, a clinical pharmacist reviews participants' medication regimens to identify potentially inappropriate medications (PIMS), and to simply regimens when indicated to facilitate medication adherence.
DM I-TEAM is a home-based behavioral intervention that involve 9 treatment visits with a community health worker (CHW) over 12 months. During the treatment visits, the CHW provides culturally-relevant diabetes education, and facilitates telehealth visits with a diabetes nurse educator and participants' primary care physicians (PCPs). In addition, a clinical pharmacist reviews participants' medication regimens to identify potentially inappropriate medications (PIMS), and to simply regimens when indicated to facilitate medication adherence.
介入なし:Usual Medical Care
Usual medical care

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
Number of emergency room visits and hospitalizations over 12 months
時間枠:12 months
The primary efficacy analysis will consider the number of incident diabetes-related ED visits and/or hospitalizations (i.e., an "event") over 12 months after the index ED visit. Each ED visit or hospitalization is counted as a single event (although an ED visit that leads to a hospitalization is counted once). ED visits and hospitalization will be ascertained through chart reviews and subject self-report.
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
hemoglobin A1c
時間枠:12 months
Subjects will have their hemoglobin A1c tested using a point of care test.
12 months
Potentially Inappropriate Medications (PIMS)
時間枠:12 months
PIMS will be assessed via chart review by a clinical pharmacist.
12 months
Physician Trust
時間枠:12 months
Physician trust will be assessed with the Multidimensional Trust in Health Care Systems. This 17-item scale measures trust in physicians (e.g., "I trust my doctor's judgment"); health payers (e.g., "Healthcare payers are good at what they do"); and health care institutions (e.g., "Healthcare institutions provide high quality care").
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:Barry Rovner, MD、Thomas Jefferson Uinversity

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 (実際)

2017年1月1日

一次修了 (実際)

2021年12月31日

研究の完了 (実際)

2021年12月31日

試験登録日

最初に提出

2017年12月31日

QC基準を満たした最初の提出物

2018年1月5日

最初の投稿 (実際)

2018年1月8日

学習記録の更新

投稿された最後の更新 (実際)

2022年10月19日

QC基準を満たした最後の更新が送信されました

2022年10月18日

最終確認日

2022年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 4100077081

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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