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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03542084
Other study ID # 2018P000683
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2018
Est. completion date August 30, 2020

Study information

Verified date September 2020
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 305
Est. completion date August 30, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Unsolicited endocrine e-consult
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

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycemic Control Mean change in HbA1c levels in the patient population 6, 12, and 18 months
Secondary Adoption of e-consult recommendations Process measures of adoption of the recommendations provided by the e-consultant 6, 12, and 18 months
Secondary A1c testing frequency number of patients who receive q6 month HbA1c testing in the study population 6,12, and 18 months
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