Endocrinology Auto-Triggered e-Consults

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03542084
Collaborator
(none)
305
1
2
23.9
12.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Unsolicited endocrine e-consult
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
305 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Endocrinology Auto-triggered E-consults on Glycemic Control
Actual Study Start Date :
Sep 4, 2018
Actual Primary Completion Date :
May 30, 2020
Actual Study Completion Date :
Aug 30, 2020

Arms and Interventions

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

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

No Intervention: Control

Control arm patients will receive usual care

Outcome Measures

Primary Outcome Measures

  1. Glycemic Control [6, 12, and 18 months]

    Mean change in HbA1c levels in the patient population

Secondary Outcome Measures

  1. Adoption of e-consult recommendations [6, 12, and 18 months]

    Process measures of adoption of the recommendations provided by the e-consultant

  2. A1c testing frequency [6,12, and 18 months]

    number of patients who receive q6 month HbA1c testing in the study population

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Daniel Horn, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel M Horn, Director of Population Health and Quality Improvement, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT03542084
Other Study ID Numbers:
  • 2018P000683
First Posted:
May 31, 2018
Last Update Posted:
Sep 4, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 4, 2020