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

Diabetes Clinical Trial

— TARGIT-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846779
• Other study ID #: 2016P000648
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: February 10, 2018

Study information

• Verified date: August 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: February 10, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• Low intensity
Low intensity telepharmacy outreach
• Moderate intensity
Moderate intensity telepharmacy outreach
• High intensity
High intensity telepharmacy outreach

Locations

Country	Name	City	State
United States	Horizon Blue Cross Blue Shield of New Jersey	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Horizon Blue Cross Blue Shield of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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