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临床试验/NCT02846779
NCT02846779已完成不适用

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

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
6,000
试验地点
2
主要终点
Insulin Persistence

研究概览

简要总结

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.

详细描述

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
None

入排标准

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

入选标准

  • 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

排除标准

  • Patients with Medicaid or Medicare as primary insurance

研究组 & 干预措施

Low intensity

Active Comparator

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.

干预措施: Low intensity (Other)

Moderate intensity

Experimental

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.

干预措施: Moderate intensity (Other)

High intensity

Experimental

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.

干预措施: High intensity (Other)

结局指标

主要结局

Insulin Persistence

时间窗: 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

次要结局

  • Change in Glycated Hemoglobin Level (HbA1c)(From 1 month (30 days) after randomization through 12 months (365 days) after randomization)
  • Number of Emergency Room Visits(From 1 month (30 days) after randomization through 12 months (365 days) after randomization)
  • Health Care Spending(From 1 month (30 days) after randomization through 12 months (365 days) after randomization)
  • Number of Physician Office Visits(From 1 month (30 days) after randomization through 12 months (365 days) after randomization)
  • Number of Hospitalizations(From 1 month (30 days) after randomization through 12 months (365 days) after randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Niteesh K. Choudhry, MD, PhD

Associate Professor, Harvard Medical School and Executive Director, Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital

Brigham and Women's Hospital

研究点 (2)

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