Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)
Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New Jersey
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Newark、New Jersey、美国、07105-2200
- Horizon Blue Cross Blue Shield of New Jersey
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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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.
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Low intensity telepharmacy outreach
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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.
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Moderate intensity telepharmacy outreach
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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.
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High intensity telepharmacy outreach
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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 |
|---|---|---|
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Insulin Persistence
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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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
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Glycated Hemoglobin Level (HbA1c)
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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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.
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Health Care Spending
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Health care spending includes prescription medications, nondrug medical services, and the combination of these two factors over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of Physician Office Visits
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of all-cause physician office visits over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of Emergency Room Visits
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of all-cause emergency room visits over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of Hospitalizations
大体时间:From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of All-cause hospitalizations over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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合作者和调查者
出版物和有用的链接
一般刊物
- Lauffenburger JC, Lewey J, Jan S, Makanji S, Ferro CA, Krumme AA, Lee J, Ghazinouri R, Haff N, Choudhry NK. Effectiveness of Targeted Insulin-Adherence Interventions for Glycemic Control Using Predictive Analytics Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190657. doi: 10.1001/jamanetworkopen.2019.0657. Erratum In: JAMA Netw Open. 2019 Jul 3;2(7):e198448.
- Lewey J, Wei W, Lauffenburger JC, Makanji S, Chant A, DiGeronimo J, Nanchanatt G, Jan S, Choudhry NK. Targeted Adherence Intervention to Reach Glycemic Control with Insulin Therapy for patients with Diabetes (TARGIT-Diabetes): rationale and design of a pragmatic randomised clinical trial. BMJ Open. 2017 Oct 30;7(10):e016551. doi: 10.1136/bmjopen-2017-016551.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
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