Clinical trial NCT02846779: Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes
Official title: Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Insulin persistence
Telepharmacy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Horizon Blue Cross Blue Shield of New Jersey
First posted: 2016-07-27
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Insulin Persistence
timeFrame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Secondary outcomes:
measure: Change in Glycated Hemoglobin Level (HbA1c)
timeFrame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
measure: Health Care Spending
timeFrame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
measure: Number of Physician Office Visits
timeFrame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
measure: Number of Emergency Room Visits
timeFrame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
measure: Number of Hospitalizations
timeFrame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Other outcomes:
Locations:
city: Newark
country: United States
facility: Horizon Blue Cross Blue Shield of New Jersey
state: New Jersey
Study officials:
affiliation: Brigham and Women's Hospital
name: Niteesh K Choudhry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.