Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015685
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-08-22
Brief Title:
Embedded Primary Care MultiDisciplinary Diabetes Clinic
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Embedding and Evaluating Multidisciplinary Diabetes Management and Continuous Glucose Monitoring Into Primary Care for a Vulnerable Population
Status:
RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
The purpose of this study is to improve diabetes management for patients at Midtown General Internal Medicine Clinic Aim 1 The clinic offers dedicated diabetes care on certain days with trained providers able to offer dedicated diabetes care The clinic will also make sure to address other aspects of life and health that may impact an individuals ability to manage their diabetes - food insecurity housing insecurity knowing about healthy food finding ways to exercise and mental health The study will also train the medical residents to be able to participate in this dedicated diabetes care Aim 2
Detailed Description:
There is a widening quality of care gap in diabetes mellitus DM management that sees Black and Hispanic patients with much higher rates of DM complications and hospitalizations compared to their white counterparts Primary Care is the frontline for DM prevention and management however Primary Care Clinics including Internal Medicine resident continuity clinics struggle to improve DM metrics The lack of resources such as time and personnel is a significant limiting factor in strategies that would allow these clinics to optimize care As a result the current DM management model was created in which Primary Care providers refer patients with elevated hemoglobin A1c HbA1c to subspecialty care This process is inefficient overwhelms subspecialty practices and most importantly does not address the social determinants of health that often make it difficult for patients to get their DM under control
This traditional model also comes with a potential institutional financial cost There is a perception that reducing upfront costs of care can make a system more economically viable yet this can have devastating results for a system and for its patients on the back end For example HbA1c is a Merit-based Incentive Payment System Clinical Quality Measure if a patient population is not supported in their efforts for DM control this can translate to monetary loss annually for the Emory Healthcare System In addition there are also potential losses to the system related to long-term morbidity and mortality risks of elevated HbA1c over time
Studies have shown that a multi-disciplinary approach including physician dietitian DM education psychotherapy and social work services functioning concurrently and cooperatively has the potential to positively change the current paradigm Given the vital role Primary Care plays in the management of all aspects of patient care including physical and psychosocial well-being this care delivery model is optimally designed to have the most impact and success in the Primary Care Clinic setting The research team proposes to embed a multi-disciplinary diabetes-focused clinic within Primary Care in the Emory Healthcare System where this approach would create a central location for all the patients DM needs provide efficient care that helps patients address social and economic barriers and engage the care team through between-clinic touchpoints to motivate patients to take agency over their health This also provides a venue to implement modern technologies for DM management such as continuous glucose monitoring CGM Despite its proven efficacy in DM management CGM remains an understudied intervention in Primary Care especially in patient populations that would otherwise have difficulty accessing specialty care Researchers anticipate that these changes will enable improved adherence to follow-up visits and treatment
In addition to the benefits of streamlined patient care this model also offers the opportunity to enhance Internal Medicine residency education Investigators intend to develop a hybrid clinicaleducational curriculum for residents that capitalizes on and models appropriate resource utilization through an integrated care model and provides early exposure to multi-disciplinary care and CGM
This traditional model also comes with a potential institutional financial cost There is a perception that reducing upfront costs of care can make a system more economically viable yet this can have devastating results for a system and for its patients on the back end For example HbA1c is a Merit-based Incentive Payment System Clinical Quality Measure if a patient population is not supported in their efforts for DM control this can translate to monetary loss annually for the Emory Healthcare System In addition there are also potential losses to the system related to long-term morbidity and mortality risks of elevated HbA1c over time
Studies have shown that a multi-disciplinary approach including physician dietitian DM education psychotherapy and social work services functioning concurrently and cooperatively has the potential to positively change the current paradigm Given the vital role Primary Care plays in the management of all aspects of patient care including physical and psychosocial well-being this care delivery model is optimally designed to have the most impact and success in the Primary Care Clinic setting The research team proposes to embed a multi-disciplinary diabetes-focused clinic within Primary Care in the Emory Healthcare System where this approach would create a central location for all the patients DM needs provide efficient care that helps patients address social and economic barriers and engage the care team through between-clinic touchpoints to motivate patients to take agency over their health This also provides a venue to implement modern technologies for DM management such as continuous glucose monitoring CGM Despite its proven efficacy in DM management CGM remains an understudied intervention in Primary Care especially in patient populations that would otherwise have difficulty accessing specialty care Researchers anticipate that these changes will enable improved adherence to follow-up visits and treatment
In addition to the benefits of streamlined patient care this model also offers the opportunity to enhance Internal Medicine residency education Investigators intend to develop a hybrid clinicaleducational curriculum for residents that capitalizes on and models appropriate resource utilization through an integrated care model and provides early exposure to multi-disciplinary care and CGM
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?:
True
Is an FDA AA801 Violation?:
None