NCT03542084

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

May 18, 2018

Last Update Submit

September 3, 2020

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Glycemic Control

    Mean change in HbA1c levels in the patient population

    6, 12, and 18 months

Secondary Outcomes (2)

  • Adoption of e-consult recommendations

    6, 12, and 18 months

  • A1c testing frequency

    6,12, and 18 months

Study Arms (2)

Intervention: Unsolicited e-consult

EXPERIMENTAL

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

Other: Unsolicited endocrine e-consult

Control

NO INTERVENTION

Control arm patients will receive usual care

Interventions

Unsolicited endocrine e-consultOTHER

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

Intervention: Unsolicited e-consult

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Terminal Illness
  • Prior visit with MGH diabetes center
  • Prior diabetes e-consult completed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Oseran AS, Rao K, Chang Y, He W, Sikora CE, Wexler DJ, Horn DM. HbA1c-Triggered Endocrinology Electronic Consultation for Type 2 Diabetes Management. J Gen Intern Med. 2022 Apr;37(5):1081-1087. doi: 10.1007/s11606-021-07157-x. Epub 2021 Oct 4.

    PMID: 34608564DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Daniel Horn, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Population Health and Quality Improvement

Study Record Dates

First Submitted

May 18, 2018

First Posted

May 31, 2018

Study Start

September 4, 2018

Primary Completion

May 30, 2020

Study Completion

August 30, 2020

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)