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

August 5, 2019 updated by: 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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

6000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Newark, New Jersey, United States, 07105-2200
        • Horizon Blue Cross Blue Shield of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Experimental: 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
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Persistence
Time Frame: 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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

February 10, 2018

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2016P000648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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