Clinical trial NCT06451458: ECHO for Diabetes and Multiple Chronic Conditions Study
Official title: ECHO for Diabetes and Multiple Chronic Conditions Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus
Chronic Disease
Keywords: Diabetes
Telehealth
Hypertension
Chronic kidney disease
Hyperlipidemia
Depression
Federally Qualified Health Center (FQHC)
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Presbyterian Medical Services
name: Patient-Centered Outcomes Research Institute
First posted: 2024-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, Cluster Randomized Clinical Trial
Primary purpose: TREATMENT

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.

Detailed description: Persons with diabetes mellitus and multiple (2+) chronic conditions (DMMC) are at increased risk of functional decline, lower quality of life, and mortality. In a state ranked among the largest, poorest, and most rural, a high proportion of the diverse residents of New Mexico (NM) belong to groups at risk for developing DMMC. Lack of access to quality healthcare is a key risk factor. Healthcare teams at Federally Qualified Health Centers (FQHCs) in medically underserved areas must have knowledge of, and be able to implement, evidence-based management guidelines to address disease complexity such as DMMC, but the healthcare teams face barriers including lack of confidence in managing complex DM and comorbid conditions and keeping up with evolving best practice guidelines. Our primary research question is whether the Project ECHO model (ECHO), a telehealth intervention for healthcare teams, can achieve significant and durable reductions in HbA1c levels relative to usual care in patients with DMMC seeking care at NM's FQHCs clinics.

Project ECHO is a "telementoring" program for remotely training healthcare teams to enable the healthcare teams to provide specialized medical care at local clinics under the ongoing mentorship of an interdisciplinary team of specialists based at academic medical centers. The ECHO model uses a combination of didactic and case-based learning to help healthcare teams, specialists, and other participants co-develop treatment plans for their patients with complex conditions. Through iterative guided practice, healthcare teams gain expertise in administering specialized medical care in primary care settings. Unlike traditional direct service or specialty consultation telehealth models, the ECHO model works on the principle of workforce multiplication, expanding access to best practice specialty healthcare by increasing healthcare team capacity to care for DMMC patients closer to their homes.

The ECHO for Diabetes and Multiple Chronic Conditions (E4DMMC) study is a cluster-randomized pragmatic trial, and will investigate the effectiveness of Project ECHO's telementoring intervention, compared to usual care practices, for optimizing the management of DMMC within vulnerable populations seeking treatment in NM FQHC clinics. E4DMMC aims to achieve, relative to the usual care arm: (1) a clinically significant ( ≥0.5%) reduction in HbA1c on average, and ≥15% reduction in rate of patients with HbA1c \> 8.5% at 18-months into-intervention; (2) significant and clinically meaningful improvements on secondary clinical outcomes for other chronic conditions (blood pressure, cholesterol level, depressive symptoms, and referrals to smoking cessation); (3) similar improvements in clinical outcomes across telehealth modalities (e.g., audio-only vs. videoconference); (4) increased adoption of clinical best practices; and (5) increased patient activation and satisfaction with care. Thus, we will evaluate outcomes at both healthcare team level and at the level of patient empaneled to the healthcare team.

Our primary patient population consists of an estimated 7000 patients with DMMC actively receiving routine care from the 20 Presbyterian Medical Services (PMS) FQHC clinics with the highest patient volume and identified through PMS EHR. This population is diverse and underserved: 45% are Hispanic/Latino, and 14% are American Indian and Alaska Native; and 48% are insured through Medicaid. Across the 20 clinics, 25-48% of these patients with DM reported an HbA1c \> 8.5%. Eleven clinics are in rural or mixed rural/urban counties, serving 55% of all patients with DMMC in this population. The median number of healthcare team members across these clinics is five, including clinicians, registered nurses, physician associates, and medical assistants.

The investigators will partner with PMS, the largest system of FQHC clinics in New Mexico to randomize 20 PMS FQHC clinics, 10 each to the ECHO intervention arm and Usual Care comparator arm. For the intervention, an ECHO program consisting 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, chronic kidney disease (CKD), hypertension, hyperlipidemia, and depression). The comparator will consist of clinical sites where healthcare teams are practicing usual care for DMMC patients, continuing standard practices for ensuring best practice care. Primary outcome data will be tracked for 21 months post-intervention in the ECHO intervention arm.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* There is no exclusion criteria.

Primary outcomes:
measure: HbA1c trajectory
timeFrame: At least once every 6 months per Electric Health Record (EHR), during 12 months baseline prior to intervention, during 18 months intervention.
measure: HbA1c level in control
timeFrame: At least once every 6 months per Electric Health Record (EHR), during 12 months baseline prior to intervention, during 18 months intervention.
Secondary outcomes:
measure: Use of any tele-med modalities for patient visits
timeFrame: 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)
measure: Hypertension
timeFrame: 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
measure: Cholesterol
timeFrame: Annual during 12 months of baseline prior to intervention, during the 18 months intervention and up to 18 months of follow-up; per EHR
measure: Kidney function
timeFrame: Annual during 12 months of baseline prior to intervention, during the 18 months intervention and up to 18 months of follow-up; per EHR
measure: Depressive symptoms - Large version
timeFrame: 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
measure: Depressive symptoms - Small version
timeFrame: 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
measure: Obesity
timeFrame: 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
measure: Receipt of appropriate exams
timeFrame: Annual during 12 months of baseline prior to intervention, during the 18 months intervention and up to 18 months of follow-up; per EHR
measure: Rates of prescribing DM meds in accordance with guidelines
timeFrame: Per encounter during 12 months baseline prior to intervention, 18 months intervention, and up to 18 months follow-up
measure: Rates of prescribing hypertension meds in accordance with guidelines
timeFrame: Per encounter during 12 months baseline prior to intervention, 18 months intervention, and up to 18 months follow-up
measure: Rates of prescribing CKD meds in accordance with guidelines
timeFrame: Per encounter during 12 months baseline prior to intervention, 18 months intervention, and up to 18 months follow-up
measure: Rates of prescribing hyperlipidemia meds in accordance with guidelines
timeFrame: Per encounter during 12 months baseline prior to intervention, 18 months intervention, and up to 18 months follow-up
measure: Rates of prescribing hypertriglyceridemia med in accordance with guidelines
timeFrame: Per encounter during 12 months baseline prior to intervention, 18 months intervention, and up to 18 months follow-up
measure: Depression care - Large and Small version
timeFrame: 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
measure: Depression care intervention
timeFrame: Per EHR, -12 to 0 months, 1 to 12 months, 13-24 months
measure: Lifestyle counseling according to guidelines
timeFrame: Annual during 12 months of baseline prior to intervention, during the 18 months intervention and up to 18 months of follow-up; per EHR
measure: Presbyterian Medical Services (PMS) Patient satisfaction survey
timeFrame: Per PMS standard patient survey; per encounter during 12 months of baseline prior to intervention, during 18 months of intervention and up to 18 months of follow-up
measure: Health behaviors
timeFrame: Per PMS standard patient survey; per encounter during 12 months of baseline prior to intervention, during 18 months of intervention and up to 18 months of follow-up
measure: Tobacco use
timeFrame: Per PMS standard patient survey; per encounter during 12 months of baseline prior to intervention, during 18 months of intervention and up to 18 months of follow-up
measure: Diet
timeFrame: Per PMS standard patient survey; per encounter during 12 months of baseline prior to intervention, during 18 months of intervention and up to 18 months of follow-up
measure: Physical exercise
timeFrame: Per PMS standard patient survey; per encounter during 12 months of baseline prior to intervention, during 18 months of intervention and up to 18 months of follow-up
Other outcomes:
measure: HbA1c levels
timeFrame: At least once every 6 months per Electric Health Record (EHR), during 12 months baseline prior to intervention, during 18 months intervention.
measure: HbA1c levels and disease progression - pre-DM
timeFrame: 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
measure: HbA1c levels and disease progression - newly diagnosed DM
timeFrame: At least once every 6 months per Electric Health Record (EHR), during 12 months baseline prior to intervention, during 18 months intervention.
measure: Patient Activation Measure (PAM)
timeFrame: Per PMS standard patient survey; during 12 months of baseline prior to intervention, during 18 months of intervention and up to 18 months of follow-up
Locations:
city: Santa Fe
country: United States
facility: Presbyterian Medical Services
state: New Mexico
Study officials:
affiliation: University of New Mexico Health Science Center
name: Sanjeev Arora, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico Health Science Center
name: Yiliang Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico Health Science Center
name: Vallabh Shah, PhD
role: STUDY_DIRECTOR
References:
citation: Arora S, Kalishman S, Dion D, Som D, Thornton K, Bankhurst A, Boyle J, Harkins M, Moseley K, Murata G, Komaramy M, Katzman J, Colleran K, Deming P, Yutzy S. Partnering urban academic medical centers and rural primary care clinicians to provide complex chronic disease care. Health Aff (Millwood). 2011 Jun;30(6):1176-84. doi: 10.1377/hlthaff.2011.0278. Epub 2011 May 19.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.