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

NCT ID: NCT02846779

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-02-10

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Low intensity

Intervention Type: OTHER

Low intensity telepharmacy outreach

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.

Group Type: EXPERIMENTAL

Moderate intensity

Intervention Type: OTHER

Moderate intensity telepharmacy outreach

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.

Group Type: EXPERIMENTAL

High intensity

Intervention Type: OTHER

High intensity telepharmacy outreach

Interventions

Low intensity

Low intensity telepharmacy outreach

Intervention Type: OTHER

Moderate intensity

Moderate intensity telepharmacy outreach

Intervention Type: OTHER

High intensity

High intensity telepharmacy outreach

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horizon Blue Cross Blue Shield of New Jersey

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Niteesh K. Choudhry, MD, PhD

Associate Professor, Harvard Medical School and Executive Director, Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niteesh K Choudhry, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Horizon Blue Cross Blue Shield of New Jersey

Newark, New Jersey, United States

Countries

United States

References

Lauffenburger JC, Lewey J, Jan S, Makanji S, Ferro CA, Krumme AA, Lee J, Ghazinouri R, Haff N, Choudhry NK. Effectiveness of Targeted Insulin-Adherence Interventions for Glycemic Control Using Predictive Analytics Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190657. doi: 10.1001/jamanetworkopen.2019.0657.

Reference Type: DERIVED

PMID: 30874782 (View on PubMed)

Lewey J, Wei W, Lauffenburger JC, Makanji S, Chant A, DiGeronimo J, Nanchanatt G, Jan S, Choudhry NK. Targeted Adherence Intervention to Reach Glycemic Control with Insulin Therapy for patients with Diabetes (TARGIT-Diabetes): rationale and design of a pragmatic randomised clinical trial. BMJ Open. 2017 Oct 30;7(10):e016551. doi: 10.1136/bmjopen-2017-016551.

Reference Type: DERIVED

PMID: 29084790 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016P000648

Identifier Type: -

Identifier Source: org_study_id