Best Practice Advisories to Reduce Inequities in Technology Use for People With Type 1 Diabetes

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
T1D Exchange, United States
Study ID
NCT06931275
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 95 Years
Healthy Volunteers
Accepted

Interventions

  • EMR-based BPA model — OTHER
    Advanced Diabetes Technologies including AIDs, insulin pumps and CGMs will be prescribed to patients after an EMR-based BPA implementation at six centers.
  • Placebo (EMR-based without BPA model) — BEHAVIORAL
    Advanced Diabetes Technologies including AIDs, insulin pumps and CGMs will be prescribed to patients after an EMR-based system without BPA at the implementation at six centers.

Study Details

The overall goal of the study is to create a standardized, stakeholder-informed system within EMRs, that will enable an equitable and regular prescription and documentation of advanced diabetes technologies. This will reduce racial disparities and generate an understanding of the reasons behind prescription decisions. The study will highlight the development and implementation an EMR-based Best Practice Advisory (BPA). The study will answer whether the EMR-based BPA can effectively reduce disparities. Additionally, it will explore why providers may not prescribe advanced diabetes technologies. Patients will also be surveyed to understand their perspectives on developing the EMR-based BPA.

Key Dates

Start date
Aug 13, 2024
Status verified
Jun 2024
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
1,178 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: ADT use following Best Practice Advisory among non- Hispanic Black and Hispanic Patients with T1D
    ADT use following a BPA intervention among non-Hispanic Black and Hispanic PwT1D receiving care at 6 T1DX-QI centers will be assessed. The EMR-based BPA will be designed to recommend ADT prescription to patients not already using some type of ADT using a rule-based algorithm. ADT will include CGM, insulin pumps, and AID systems. We will work with each of the 6 centers to implement the BPA as part of the Epic EMR. The function will generate a BPA if patient is not utilizing a CGM or pump/AID. If the patient is not on a CGM, pump or AID system (if already using CGM and pump), the BPA will suggest discussing and/or prescribing CGM (or pump/AID) to the provider. The provider will answer in the affirmative or say, "not discussed" or "patient declined." If the provider chooses to opt out of prescribing, they will be forced to provide a reason for not prescribing to advance the screen. Providers in each intervention center will be trained on the BPA process prior to implementation.
  • Placebo Comparator: ADT use among non- Hispanic Black and Hispanic Patients with T1D
    The arm will comprise of a matched control non-Hispanic Black and Hispanic PwT1D receiving care at a center over a 12-month period. Participants will be matched on the basis of Age categories, biological sex, Insurance status, Area deprivation index, Baseline Technology use, Duration of T1D bins, and Baseline HbA1c.

Primary Outcome Measure

Progression of Advanced Diabetes Technology use [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
T1D ExchangeBostonMassachusetts02110
Osagie Ebekozien, MPH, MD
857-205-2388
Trevon Wright, MHA
617-892-7564
Osagie Ebekozien, MD, MPH (PRINCIPAL_INVESTIGATOR)
Nestoras Mathioudakis, MD, MHS (SUB_INVESTIGATOR)
Risa Wolf, MD (SUB_INVESTIGATOR)
T1D ExchangeBostonMassachusetts02111
Osagie Ebekozien, MD
8572052388
Trevon Wright, MHA
2569497029

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