Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes
TARGIT-DM
1 other identifier
interventional
6,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 25, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2018
CompletedResults Posted
Study results publicly available
August 7, 2019
CompletedAugust 7, 2019
August 1, 2019
1.5 years
July 25, 2016
March 5, 2019
August 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Change in Glycated Hemoglobin Level (HbA1c)
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Health Care Spending
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Number of Physician Office Visits
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Number of Emergency Room Visits
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Number of Hospitalizations
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
Study Arms (3)
Low intensity
ACTIVE COMPARATORAll 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.
Moderate intensity
EXPERIMENTALParticipants 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.
High intensity
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with Medicaid or Medicare as primary insurance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Horizon Blue Cross Blue Shield of New Jersey
Newark, New Jersey, 07105-2200, United States
Related Publications (2)
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.
PMID: 30874782DERIVEDLewey 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.
PMID: 29084790DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Niteesh K. Choudhry, MD, PhD
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Niteesh K Choudhry, MD, PhD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Harvard Medical School and Executive Director, Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital
Study Record Dates
First Submitted
July 25, 2016
First Posted
July 27, 2016
Study Start
July 1, 2016
Primary Completion
December 30, 2017
Study Completion
February 10, 2018
Last Updated
August 7, 2019
Results First Posted
August 7, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share