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Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)

2019年8月5日 更新者:Niteesh K. Choudhry, MD, PhD、Brigham and Women's Hospital

Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)

The purpose of this study is to evaluate three pharmacist-outreach strategies for improving adherence to insulin among individuals with diabetes. The three approaches are equivalently-priced but vary by degree of targeting and intervention intensity.

研究概览

详细说明

In an era of rapidly growing healthcare costs, due to in large part to the increasing burden and complexity of chronic disease management, targeting outreach to patients who are most likely to benefit from them and tailoring interventions to individual patient needs, represent important opportunities to maximize healthcare value. The Targeted Adherence intervention to Reach Glycemic control with Insulin Therapy for patients with Diabetes (TARGIT-DM) trial is a pragmatic, intention-to-treat, randomized-controlled study that will evaluate the impact of three equivalently-priced strategies to improve insulin persistence and glycosylated hemoglobin [HbA1c] control among patients with diabetes on insulin.

The interventions in each of the three study arms will consist of educational mailings and telephonic pharmacist outreach. The pharmacists will assess and address potential barriers to insulin adherence and optimal glycemic control. The three study arms will employ differ both in regards to which patients are targeted and the intensity of the engagement strategy used. The low intensity intervention in arm 1 will be deployed to all subjects randomized to that arm. The moderate and high intensity interventions will be delivered to focused populations within arms 2 and 3, respectively, as defined by poor disease control and/or predicted risk of non-adherence. The interventions provided in the moderate and high intensity arms will also include feedback to the patient's provider, as needed, and potential enrollment in a text messaging program. Patients in these two arms who are not targeted will receive usual care.

The study population for this trial will consist of members enrolled in commercial insurance provided by Horizon Blue Cross Blue Shield of New Jersey. Insurance claims data will be used to apply the inclusion and exclusion criteria. Eligible patients will be randomized into one of three arms, stratified by baseline availability of HbA1c and a valid telephone number.

研究类型

介入性

注册 (实际的)

6000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Jersey
      • Newark、New Jersey、美国、07105-2200
        • Horizon Blue Cross Blue Shield of New Jersey

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Commercially-insured individuals receiving medical and pharmacy health insurance benefits from Horizon Blue Cross Blue Shield of New Jersey
  • At least 3 months of continuous enrollment prior to randomization
  • At least 1 prescription for basal insulin, 6 months prior to randomization
  • Type 2 diabetes diagnosis

Exclusion Criteria:

  • Patients with Medicaid or Medicare as primary insurance

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Low intensity
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity telepharmacy outreach
实验性的:Moderate intensity
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity telepharmacy outreach
实验性的:High intensity
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity telepharmacy outreach

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Insulin Persistence
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Percentage of participants who were non-persistent if they did not refill insulin before a set threshold of time over the entire follow-up period
From 1 month (30 days) after randomization through 12 months (365 days) after randomization

次要结果测量

结果测量
措施说明
大体时间
Change in Glycated Hemoglobin Level (HbA1c)
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
The percent change in HbA1c level between the latest baseline value to the latest follow up value, among those with at least 1 baseline HbA1c available.
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Health Care Spending
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Health care spending includes prescription medications, nondrug medical services, and the combination of these two factors over the entire follow-up period
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Number of Physician Office Visits
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Number of all-cause physician office visits over the entire follow-up period
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Number of Emergency Room Visits
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Number of all-cause emergency room visits over the entire follow-up period
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Number of Hospitalizations
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Number of All-cause hospitalizations over the entire follow-up period
From 1 month (30 days) after randomization through 12 months (365 days) after randomization

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年7月1日

初级完成 (实际的)

2017年12月30日

研究完成 (实际的)

2018年2月10日

研究注册日期

首次提交

2016年7月25日

首先提交符合 QC 标准的

2016年7月26日

首次发布 (估计)

2016年7月27日

研究记录更新

最后更新发布 (实际的)

2019年8月7日

上次提交的符合 QC 标准的更新

2019年8月5日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2016P000648

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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