Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638099
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-05
Brief Title:
Increasing CGM Use Among Patients With T2D
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Increasing Use of Continuous Glucose Monitors Among Patients With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Overview
This interventional study aims to assess whether training healthcare professionals HCPs increases the number of continuous glucose monitor CGM prescriptions for patients with Type 2 Diabetes in a Federally Qualified Health Center serving a predominantly HispanicLatino population
Research Questions
Does HCP training enhance CGM prescription rates in a primary care setting Does receiving a CGM prescription lead to improved Type 2 Diabetes control as measured by Hemoglobin A1c levels What barriers do patients face when prescribed and using CGMs Given the significant impact of CGMs on diabetes management this project seeks to improve CGM utilization among eligible patients through a focused intervention for HCPs and evaluate diabetes outcomes for those who do and do not receive a CGM
Methodology
HCPs and staff from three clinics within the same healthcare system will undergo a brief in-person training on current clinical guidelines and insurance eligibility for CGMs A booster session will follow about one month later to reinforce learning and address any prescribing challenges
Training efficacy will be evaluated by comparing CGM prescription rates before and after training using electronic health records HCPs will complete pre- and post-training surveys to assess changes in knowledge beliefs and prescribing practices related to CGMs Additionally a small subset of prescribers will participate in interviews about their experiences with CGM prescriptions four months post-training
Patient Recruitment and Surveys
Patients with Type 2 Diabetes will be recruited for surveys at baseline and at 3 and 6 months These surveys will gather information on their diabetes management experience levels of diabetes distress and whether CGM discussions occurred with their primary care provider Participants who received CGM prescriptions will share their experiences and any barriers encountered A subset will also be invited for interviews to further explore their CGM experiences
Conclusion
This study seeks to fill a crucial gap in understanding how HCP training influences CGM prescription rates and the associated diabetes management outcomes ultimately aiming to enhance diabetes care for a vulnerable population
This interventional study aims to assess whether training healthcare professionals HCPs increases the number of continuous glucose monitor CGM prescriptions for patients with Type 2 Diabetes in a Federally Qualified Health Center serving a predominantly HispanicLatino population
Research Questions
Does HCP training enhance CGM prescription rates in a primary care setting Does receiving a CGM prescription lead to improved Type 2 Diabetes control as measured by Hemoglobin A1c levels What barriers do patients face when prescribed and using CGMs Given the significant impact of CGMs on diabetes management this project seeks to improve CGM utilization among eligible patients through a focused intervention for HCPs and evaluate diabetes outcomes for those who do and do not receive a CGM
Methodology
HCPs and staff from three clinics within the same healthcare system will undergo a brief in-person training on current clinical guidelines and insurance eligibility for CGMs A booster session will follow about one month later to reinforce learning and address any prescribing challenges
Training efficacy will be evaluated by comparing CGM prescription rates before and after training using electronic health records HCPs will complete pre- and post-training surveys to assess changes in knowledge beliefs and prescribing practices related to CGMs Additionally a small subset of prescribers will participate in interviews about their experiences with CGM prescriptions four months post-training
Patient Recruitment and Surveys
Patients with Type 2 Diabetes will be recruited for surveys at baseline and at 3 and 6 months These surveys will gather information on their diabetes management experience levels of diabetes distress and whether CGM discussions occurred with their primary care provider Participants who received CGM prescriptions will share their experiences and any barriers encountered A subset will also be invited for interviews to further explore their CGM experiences
Conclusion
This study seeks to fill a crucial gap in understanding how HCP training influences CGM prescription rates and the associated diabetes management outcomes ultimately aiming to enhance diabetes care for a vulnerable population
Detailed Description:
Background Significance Approximately 30 million adults in the US suffer from diabetes a chronic condition with serious long-term health and social consequences Diabetes is a leading cause of death and disability across the country that disproportionately burdens minoritized ethnoracial low-income and rural populations-such as in the border-area region of Imperial County CA where diabetes rates far exceed state and national averagesContinuous glucose monitoring CGM is increasingly recognized as a valuable tool for patients with Type 1 and Type 2 Diabetes T1D and T2D respectively with use of the technology associated with improved disease management reduced diabetes distress and healthcare costs Unfortunately while clinical practice guidelines recommend use of CGM in diabetes care inequities in CGM use threaten to exacerbate existing diabetes disparities For instance patients from minoritized ethnoracial groups particularly Hispanic and Black patients are less likely to use CGM than non-Hispanic white patients
Disparities in CGM use may be attributed to a variety of factors However the most common barrier reported by both patients and providers is limited uptake due to perceived cost Research has shown that providers may not prescribe CGM due to concerns about costs and their lack of knowledge about insurance eligibility requirements Fortunately recent expansions in insurance coverage mean costs may no longer prohibit access to CGM for low-income patients who meet clinical eligibility criteria Notwithstanding many providers may not prescribe CGM even to those who qualify for coverage This may be particularly true among primary care providers who increasingly serve as the primary point of care for patients with diabetes living in rural and medically underserved areas without access to an endocrinologist A study of over 600 HCPs showed that only 386 had ever prescribed CGM but nearly two-thirds said they would be likely to do so with increased education on CGM or consultation on insurance requirements Thus educating HCP on current CGM clinical practice recommendations and insurance coverage eligibility requirements could greatly improve CGM prescriptions in clinics serving low-income and ethnoracially diverse patients
While increasing CGM prescriptions is an important step to providing more equitable access to CGM additional intervention may be needed to ensure patients from historically marginalized communities can access and use the devices More specifically once prescribed CGM effectiveness is contingent on patients acquiring applying and using the device Research has shown that patients may share their providers uncertainty over coverage eligibility requirements and out-of-pocket costs associated with CGM use a study of over 1500 patients with T1D found the most reported concerns about using CGM were insurance coverage and costs If not addressed cost concerns could impede patients from acquiring CGMs even if prescribed by their healthcare provider HCP
Given the potential impact of CGM on diabetes management efforts to increase CGM uptake are critically needed especially in historically marginalized and under-resourced regions without access to diabetes specialty care Strategies such as educating HCP on current CGM eligibility criteria and insurance costs and improving patient education on costs may be effective in increasing initial CGM uptake and ultimately improving patient outcomes However no prior studies have evaluated the impact of these strategies in low-resource primary care settings or with HispanicLatino patients Existing studies have also primarily focused on CGM use and impact in patients with T1D rather than T2D The proposed project will fill this gap by evaluating the impact of a system-level provider-focused intervention on CGM prescription rates and diabetes outcomes for eligible patients with T2D of a large Federally-Qualified Health Center in Imperial County California
The project will be guided by the following aims
1Determine whether the proportion of T2D patients who are prescribed CGM significantly increases following a system-level CGM intervention that is implemented sequentially in three different clinics HCPs and staff will participate in a training and receive a CGM prescription toolkit including procedures for determining clinical eligibility insurance documentation templates scripts for communication with patients and patient education materials with information about CGM benefits how and where to acquire the device and any anticipated out-of-pocket costs CGM prescription rates will be extracted from electronic health records EHR to determine changes over time H1 CGM prescription rate for T2D patients will increase significantly after the intervention
1a Evaluate impact of toolkit training on knowledge and attitudes towards CGM among HCPStaff H2 Knowledge and attitudes towards CGM will significantly improve following completion of the toolkit training
2 Compare changes in A1C values over time between T2D patients who do and do not receive a CGM A1C values will be extracted from the EHR to compare changes over time among patients with T2D who received and filled a new CGM prescription vs never received or did not fill their prescription H0 Patients who use CGM will show significantly greater improvement in A1C values over 6 months compared to those who did not use CGM
2a Determine whether the impact of CGM use on A1C is mediated by changes in diabetes distress H2 Reductions in diabetes distress will mediate the relationship between CGM use and A1C among patients
3Identify factors that influence CGM uptake among healthcare providers staff and patients Providers staff and patients will complete interviews about their experiences with CGM post-intervention H3 NA
Research Design Methods
The study aims will be achieved in a three-phase three-year project This study will be conducted in collaboration with Innercare which is a federally-qualified health center in Imperial County CA and participants will include healthcare professionals HCPsl including prescribing clinicians and their staff and patients recruited from the three largest Innercare clinics in Imperial County Brawley El Centro Calexico In Phase 1 the investigators will evaluate a systems-level intervention CGM prescription toolkit and associated training for HCPs and staff designed to improve CGM prescription rates among patients with T2D in primary care clinics Aim 1 1a 3 In Phase 2 the impact of CGM use on diabetes management among patients with T2D will be evaluated through an examination of A1C laboratory values extracted from the electronic health records EHR of patients who were prescribed and received a CGM during the study period Aim 2 Additionally the mechanisms of action for CGM will be explored by examining diabetes distress as a mediator between CGM use and A1C values among a subset of patients who complete a self-report survey that will be linked to their EHR data Aim 2a In Phase 3 patients will participate in one-on-one interviews about their experiences with CGM including challenges and facilitators to accessing and using the technology Aim 3
Disparities in CGM use may be attributed to a variety of factors However the most common barrier reported by both patients and providers is limited uptake due to perceived cost Research has shown that providers may not prescribe CGM due to concerns about costs and their lack of knowledge about insurance eligibility requirements Fortunately recent expansions in insurance coverage mean costs may no longer prohibit access to CGM for low-income patients who meet clinical eligibility criteria Notwithstanding many providers may not prescribe CGM even to those who qualify for coverage This may be particularly true among primary care providers who increasingly serve as the primary point of care for patients with diabetes living in rural and medically underserved areas without access to an endocrinologist A study of over 600 HCPs showed that only 386 had ever prescribed CGM but nearly two-thirds said they would be likely to do so with increased education on CGM or consultation on insurance requirements Thus educating HCP on current CGM clinical practice recommendations and insurance coverage eligibility requirements could greatly improve CGM prescriptions in clinics serving low-income and ethnoracially diverse patients
While increasing CGM prescriptions is an important step to providing more equitable access to CGM additional intervention may be needed to ensure patients from historically marginalized communities can access and use the devices More specifically once prescribed CGM effectiveness is contingent on patients acquiring applying and using the device Research has shown that patients may share their providers uncertainty over coverage eligibility requirements and out-of-pocket costs associated with CGM use a study of over 1500 patients with T1D found the most reported concerns about using CGM were insurance coverage and costs If not addressed cost concerns could impede patients from acquiring CGMs even if prescribed by their healthcare provider HCP
Given the potential impact of CGM on diabetes management efforts to increase CGM uptake are critically needed especially in historically marginalized and under-resourced regions without access to diabetes specialty care Strategies such as educating HCP on current CGM eligibility criteria and insurance costs and improving patient education on costs may be effective in increasing initial CGM uptake and ultimately improving patient outcomes However no prior studies have evaluated the impact of these strategies in low-resource primary care settings or with HispanicLatino patients Existing studies have also primarily focused on CGM use and impact in patients with T1D rather than T2D The proposed project will fill this gap by evaluating the impact of a system-level provider-focused intervention on CGM prescription rates and diabetes outcomes for eligible patients with T2D of a large Federally-Qualified Health Center in Imperial County California
The project will be guided by the following aims
1Determine whether the proportion of T2D patients who are prescribed CGM significantly increases following a system-level CGM intervention that is implemented sequentially in three different clinics HCPs and staff will participate in a training and receive a CGM prescription toolkit including procedures for determining clinical eligibility insurance documentation templates scripts for communication with patients and patient education materials with information about CGM benefits how and where to acquire the device and any anticipated out-of-pocket costs CGM prescription rates will be extracted from electronic health records EHR to determine changes over time H1 CGM prescription rate for T2D patients will increase significantly after the intervention
1a Evaluate impact of toolkit training on knowledge and attitudes towards CGM among HCPStaff H2 Knowledge and attitudes towards CGM will significantly improve following completion of the toolkit training
2 Compare changes in A1C values over time between T2D patients who do and do not receive a CGM A1C values will be extracted from the EHR to compare changes over time among patients with T2D who received and filled a new CGM prescription vs never received or did not fill their prescription H0 Patients who use CGM will show significantly greater improvement in A1C values over 6 months compared to those who did not use CGM
2a Determine whether the impact of CGM use on A1C is mediated by changes in diabetes distress H2 Reductions in diabetes distress will mediate the relationship between CGM use and A1C among patients
3Identify factors that influence CGM uptake among healthcare providers staff and patients Providers staff and patients will complete interviews about their experiences with CGM post-intervention H3 NA
Research Design Methods
The study aims will be achieved in a three-phase three-year project This study will be conducted in collaboration with Innercare which is a federally-qualified health center in Imperial County CA and participants will include healthcare professionals HCPsl including prescribing clinicians and their staff and patients recruited from the three largest Innercare clinics in Imperial County Brawley El Centro Calexico In Phase 1 the investigators will evaluate a systems-level intervention CGM prescription toolkit and associated training for HCPs and staff designed to improve CGM prescription rates among patients with T2D in primary care clinics Aim 1 1a 3 In Phase 2 the impact of CGM use on diabetes management among patients with T2D will be evaluated through an examination of A1C laboratory values extracted from the electronic health records EHR of patients who were prescribed and received a CGM during the study period Aim 2 Additionally the mechanisms of action for CGM will be explored by examining diabetes distress as a mediator between CGM use and A1C values among a subset of patients who complete a self-report survey that will be linked to their EHR data Aim 2a In Phase 3 patients will participate in one-on-one interviews about their experiences with CGM including challenges and facilitators to accessing and using the technology Aim 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None