Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes
- Conditions
- Diabetes
- Registration Number
- NCT02846779
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6000
- 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
- Patients with Medicaid or Medicare as primary insurance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Insulin Persistence 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
- Secondary Outcome Measures
Name Time Method Number of Hospitalizations 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
Change in Glycated Hemoglobin Level (HbA1c) 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.
Number of Emergency Room Visits 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
Health Care Spending 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
Number of Physician Office Visits 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
Trial Locations
- Locations (1)
Horizon Blue Cross Blue Shield of New Jersey
🇺🇸Newark, New Jersey, United States
Horizon Blue Cross Blue Shield of New Jersey🇺🇸Newark, New Jersey, United States