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Completed

NCT Number: NCT02846779

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Horizon Blue Cross Blue Shield of New Jersey

Newark, New Jersey, 07105-2200, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Intensity

Other

Low intensity telepharmacy outreach

Moderate intensity

Other

Moderate intensity telepharmacy outreach

High Intensity

Other

High intensity telepharmacy outreach

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Horizon Blue Cross Blue Shield of New Jersey

Registry information

Official study title

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

Acronym: TARGIT-DM

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 27, 2016
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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