- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03542084
Endocrinology Auto-Triggered e-Consults
Impact of Endocrinology Auto-triggered E-consults on Glycemic Control
Diabetes currently affects 25.8 million people in the U.S. Patients with diabetes are generally managed, at least initially, by a primary care practitioner (PCP). As the prevalence of diabetes continues to rise, PCPs are under increased pressure to achieve recommended glycemic targets. Failure to achieve these targets has been shown to increase clinical complications and cost of care.
Endocrinology referral is common for those patients not meeting A1c goals. Unfortunately, access to specialty endocrinology care is limited and patients routinely wait weeks or months before being seen. Electronic consultation (e-consult) is a new and innovative delivery model that has the potential to provide greater access to specialty care. The current system at Massachusetts General Hospital (MGH) allows PCPs to electively place an e-consult to solicit specialist input. Specialists in turn review the patients chart, relevant data and the clinical question and respond within the electronic medical record. E-consults have been well received by both patients and physicians, not only at MGH, but also across many centers in the US. With that said, the e-consult system remains in its infancy and current literature largely focuses on process metrics without hard clinical end-points.
One way to optimize care for patients with diabetes is to automatically trigger an endocrinology e-consult for those not meeting A1c targets. The goal of this project will be to conduct a rigorous scientific evaluation of auto-triggered e-consults across Massachusetts General Hospitals affiliated primary care practices. The e-consults will be unsolicited and triggered based on inclusion criteria that include a1c and date of last PCP visit. This project will leverage an existing diabetes population health registry that is being used currently for ongoing diabetes care initiatives.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diabetic patients with a PCP at Massachusetts General Hospital and HbA1c between 8-10 who have seen their PCP in the office within 18 months
Exclusion Criteria:
- Terminal Illness
- Prior visit with MGH diabetes center
- Prior diabetes e-consult completed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention: Unsolicited e-consult
The PCP of intervention arm patients will receive an unsolicited e-consult by an endocrinologist offering clinical guidance on how to optimize the patients' glycemic control
|
The PCP for intervention arm patients will receive an unsolicited e-consult from an endocrinologist with recommendations on how to improve glycemic control in the intervention patient
|
NO_INTERVENTION: Control
Control arm patients will receive usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic Control
Time Frame: 6, 12, and 18 months
|
Mean change in HbA1c levels in the patient population
|
6, 12, and 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adoption of e-consult recommendations
Time Frame: 6, 12, and 18 months
|
Process measures of adoption of the recommendations provided by the e-consultant
|
6, 12, and 18 months
|
A1c testing frequency
Time Frame: 6,12, and 18 months
|
number of patients who receive q6 month HbA1c testing in the study population
|
6,12, and 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Horn, MD, Massachusetts General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018P000683
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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