ECHO for Diabetes and Multiple Chronic Conditions Study

NCT06451458 | Enrolling By Invitation DMC

• 2 other identifiers: 24-211TE-2022C3-30560
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes mellitus is a chronic condition that affects the body's ability to process sugar effectively, which over time can increase the risk of heart disease, high blood pressure, and kidney damage. Other chronic conditions include high cholesterol, obesity, and depression. Persons with diabetes mellitus and multiple chronic conditions (DMMC) face higher risks of losing physical or mental function, experiencing other chronic conditions, and death. Most of the residents of New Mexico (NM) belong to groups at risk for developing DMMC. Finding quality healthcare is a key factor, as NM also ranks among the largest, poorest, and most rural states. Primary care providers (PCPs) most often treat DMMC patients, but healthcare teams can lack confidence in managing these complex patients and struggle to keep up with recommended guidelines. This Project ECHO model (ECHO) for DMMC, a telehealth intervention for healthcare teams, can lead to lower blood sugar levels in DMMC patients being treated at NM primary care clinics. ECHO is a "telementoring" program that trains healthcare teams to provide specialized medical care at their local clinics. This is done by connecting healthcare teams with specialist mentors at academic medical centers through videoconferencing sessions. During ECHO program sessions, groups of healthcare teams hear lectures on key topics in DMMC care from experts, and then give presentations of anonymous patient cases by a healthcare teams for discussion and to receive recommendations. This clinical pragmatic trial aims to learn if the intervention will improve patient blood sugar levels in persons with DMMC who are being treated at selected health clinic sites throughout New Mexico. The study aims to answer:

• Whether a 0.5% drop in HbA1c on average can be achieved in the group whose healthcare teams are receiving the ECHO intervention compared to the comparator group, whose providers will not receive the intervention.
• Whether the rate of an individual's HbA1c was greater than 8.5% at the baseline will be reduced by 15% at the end of the intervention. Researchers will compare health data for patients empaneled to healthcare teams in the study and the usual care comparator group both before and after the intervention period to see whether the ECHO model has a positive influence on test results.

Conditions

Diabetes Mellitus; Chronic Disease

Keywords

Diabetes; Telehealth; Hypertension; Chronic kidney disease; Hyperlipidemia; Depression; Federally Qualified Health Center (FQHC)

Outcome Measures

Primary Outcomes (2)

• HbA1c trajectory

  A decreasing trajectory in patients' HbA1c over time during and following ECHO intervention, reaching an average of 0.5% drop 18 months into intervention compared with comparator

  At least once every 6 months per Electric Health Record (EHR), during 12 months baseline prior to intervention, during 18 months intervention.

• HbA1c level in control

  15% decreases in per-patient rate of HbA1c\>8.5% by 18 months into intervention, respectively, compared with comparator

  At least once every 6 months per Electric Health Record (EHR), during 12 months baseline prior to intervention, during 18 months intervention.

Secondary Outcomes (21)

• Use of any tele-med modalities for patient visits

  Every encounter per EHR during 12 months baseline prior to intervention, during the study period (18 months intervention and up to 18 months follow-up for the intervention arm)

• Hypertension

  Per encounter; per EHR during 12 months of baseline prior to intervention, during the 18 months of intervention period and up to 18 months of follow-up

• Cholesterol

  Annual during 12 months of baseline prior to intervention, during the 18 months intervention and up to 18 months of follow-up; per EHR

• Kidney function

  Annual during 12 months of baseline prior to intervention, during the 18 months intervention and up to 18 months of follow-up; per EHR

• Depressive symptoms - Large version

  Per encounter; per EHR during 12 months of baseline prior to intervention, during the 18 months of intervention period and up to 18 months of follow-up

Other Outcomes (4)

• HbA1c levels

  At least once every 6 months per Electric Health Record (EHR), during 12 months baseline prior to intervention, during 18 months intervention.

• HbA1c levels and disease progression - pre-DM

  Per encounter; per EHR during 12 months of baseline prior to intervention, during the 18 months of intervention period and up to 18 months of follow-up

• HbA1c levels and disease progression - newly diagnosed DM

  At least once every 6 months per Electric Health Record (EHR), during 12 months baseline prior to intervention, during 18 months intervention.

Study Arms (2)

ECHO Intervention

EXPERIMENTAL

10 FQHCs from the PMS health system will be randomized to the ECHO Intervention Arm. All healthcare team members in the intervention arm will attend ECHO program sessions, and the FQHCs are the primary subjects of the ECHO intervention. However, the investigators examine outcomes at both the level of the healthcare team and at the level of the patients who are empaneled to the healthcare team. Persons with DMMC cared for by the healthcare teams at the FQHC clinics are the patient population for this intervention.

Behavioral: ECHO program for DMMC

Comparator

ACTIVE COMPARATOR

10 FQHCs from the PMS health system will be randomized to the comparator arm which is usual care. Persons with DMMC cared for by the healthcare teams at the FQHC clinics are the patient population for this comparator arm.

Behavioral: Usual care

Interventions

ECHO program for DMMC BEHAVIORAL

For the intervention, an 18-month ECHO program of weekly videoconference sessions will mentor healthcare teams on complex care strategies for patients with DMMC, emphasizing evidence-based best practices related to common chronic conditions (e.g., diabetes, CKD, hypertension, hyperlipidemia and depression). Mentorship will be provided by a multidisciplinary team of experts including a patient representative, diabetes educator, endocrinologist, psychiatrist, a nephrologist/kidney disease and hypertension specialist, a clinical pharmacist, and a cardiology consultant. Each session will consist of a didactic presentation, de-identified patient case presentations, and questions and discussion.

ECHO Intervention

Usual care BEHAVIORAL

The comparator will consist of 10 PMS FQHC clinics with healthcare teams practicing usual care according to PMS standard practices during the 18 months of the intervention arm.

Comparator

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Twenty PMS sites with the highest patient volume.
• All members of the PMS sites (participants) healthcare teams between 18 and 89 years of age, all genders, and all ethnicities.

Sponsors & Collaborators

• University of New Mexico: lead
• Presbyterian Medical Services: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Presbyterian Medical Services

Santa Fe, New Mexico, 87501, United States

Location

Related Publications (8)

• Callis PD, Santini A. A suggested role for polymorphonuclear leukocytes in the perpetuation of periapical disease. Oral Surg Oral Med Oral Pathol. 1985 Jan;59(1):88-90. doi: 10.1016/0030-4220(85)90122-7.

  PMID: 3856208 BACKGROUND

• Arora S, Kalishman SG, Thornton KA, Komaromy MS, Katzman JG, Struminger BB, Rayburn WF, Bradford AM. Project ECHO: A Telementoring Network Model for Continuing Professional Development. J Contin Educ Health Prof. 2017 Fall;37(4):239-244. doi: 10.1097/CEH.0000000000000172.

  PMID: 29189491 BACKGROUND

• Arora S, Thornton K, Murata G, Deming P, Kalishman S, Dion D, Parish B, Burke T, Pak W, Dunkelberg J, Kistin M, Brown J, Jenkusky S, Komaromy M, Qualls C. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med. 2011 Jun 9;364(23):2199-207. doi: 10.1056/NEJMoa1009370. Epub 2011 Jun 1.

  PMID: 21631316 BACKGROUND

• MATTHEW F. BOUCHONVILLE, ERIK B. ERHARDT, YURIDIA L. LEYVA, LARISSA MYASKOVSKY, MARK L. UNRUH, SANJEEV ARORA; 1029-P: Building Diabetes Care Capacity in Rural Underserved Communities-A Comparison of Cardiorenal Risk Factor Outcomes in Patients Treated by ECHO-Trained Providers vs. an Academic Medical Center. Diabetes 20 June 2023; 72 (Supplement_1): 1029-P. https://doi.org/10.2337/db23-1029-P

  BACKGROUND

• Bouchonville MF, Hager BW, Kirk JB, Qualls CR, Arora S. ENDO ECHO IMPROVES PRIMARY CARE PROVIDER AND COMMUNITY HEALTH WORKER SELF-EFFICACY IN COMPLEX DIABETES MANAGEMENT IN MEDICALLY UNDERSERVED COMMUNITIES. Endocr Pract. 2018 Jan;24(1):40-46. doi: 10.4158/EP-2017-0079.

  PMID: 29368967 BACKGROUND

• Bouchonville MF, Paul MM, Billings J, Kirk JB, Arora S. Taking Telemedicine to the Next Level in Diabetes Population Management: a Review of the Endo ECHO Model. Curr Diab Rep. 2016 Oct;16(10):96. doi: 10.1007/s11892-016-0784-9.

  PMID: 27549110 BACKGROUND

• Nelson RG, Pankratz VS, Ghahate DM, Bobelu J, Faber T, Shah VO. Home-Based Kidney Care, Patient Activation, and Risk Factors for CKD Progression in Zuni Indians: A Randomized, Controlled Clinical Trial. Clin J Am Soc Nephrol. 2018 Dec 7;13(12):1801-1809. doi: 10.2215/CJN.06910618. Epub 2018 Nov 15.

  PMID: 30442864 BACKGROUND

• Paul M, Davila Saad A, Billings J, Blecker S, Bouchonville MF, Berry C. MON-190 Endo ECHO Improves Patient-Reported Measures of Access to Care, Health Care Quality, Self-Care Behaviors, and Overall Quality of Life for Patients with Complex Diabetes in Medically Underserved Areas of New Mexico. J Endocr Soc. 2019 Apr 30;3(Suppl 1):MON-190. doi: 10.1210/js.2019-MON-190. PMCID: PMC6551170.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Disease; Hypertension; Renal Insufficiency, Chronic; Hyperlipidemias; Depression

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Dyslipidemias; Lipid Metabolism Disorders; Behavioral Symptoms; Behavior

Study Officials

• Yiliang Zhu, PhD

  University of New Mexico Health Science Center

  PRINCIPAL INVESTIGATOR

• Matthew Bouchonville, MD

  University of New Mexico Health Science Center

  PRINCIPAL INVESTIGATOR

• Vallabh Shah, PhD

  University of New Mexico Health Science Center

  STUDY DIRECTOR

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: Professor

Model Details: Pragmatic, Cluster Randomized Clinical Trial

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 11, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)