Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Other: Low intensity
* Other: Moderate intensity
* Other: High intensity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low intensity<br>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. | Other: Low intensity<br>* Low intensity telepharmacy outreach<br>|
| Experimental: Moderate intensity<br>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. | Other: Moderate intensity<br>* Moderate intensity telepharmacy outreach<br>|
| Experimental: High intensity<br>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. | Other: High intensity<br>* High intensity telepharmacy outreach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Persistence | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycated Hemoglobin Level (HbA1c) | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin persistence, Telepharmacy