Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-20
Brief Title:
ECHO for Diabetes and Multiple Chronic Conditions Study
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
ECHO for Diabetes and Multiple Chronic Conditions Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E4DMMC
Brief Summary:
Diabetes mellitus is a chronic condition that affects the bodys 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 05 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 individuals HbA1c was greater than 85 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
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 05 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 individuals HbA1c was greater than 85 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 NMs 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 ECHOs 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 05 reduction in HbA1c on average and 15 reduction in rate of patients with HbA1c 85 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 eg 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 HispanicLatino 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 85 Eleven clinics are in rural or mixed ruralurban 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 eg 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
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 ECHOs 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 05 reduction in HbA1c on average and 15 reduction in rate of patients with HbA1c 85 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 eg 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 HispanicLatino 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 85 Eleven clinics are in rural or mixed ruralurban 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TE-2022C3-30560 | OTHER_GRANT | Patient Centered Outcomes Research Institute | None |