Increasing Use of Continuous Glucose Monitors Among Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- CGM prescription rates
研究概览
简要总结
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 Hispanic/Latino 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.
详细描述
Background & Significance: Approximately 30 million adults in the U.S. 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 averages.Continuous 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 38.6% 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 1,500 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 Hispanic/Latino 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant Eligibility:
- •adults 18 years or older,
- •have been diagnosed with T2D at least one year prior to recruitment,
- •are a current patient of one of the three participating Innercare Clinics with no -
- •plans to discontinue their care at Innercare within the next 6 months,
- •can understand and speak in English or Spanish,
- •have telephone access,
- •do not plan to move out of the area within the next 6 months.
排除标准
- •Plans to move out of the area in the next 6 months
- •Patients with newly diagnose diabetes mellitus (less than one year), diabetes insipidus, diabetes type 1 or gestational diabetes.
- •Provider/Staff Eligibility:
- •18 years or older,
- •able to read and write in English,
- •currently employed at one of the participating Innercare clinics (Brawley, El Centro, Calexico),
- •currently be treating at least one adult patient for T2D, scheduled to complete the CGM toolkit training. Exclusion
- •Personnel without experience providing care to adult patients with T2D in primary care settings.
研究组 & 干预措施
Healthcare Prescribers Exposed to CGM Prescriber Toolkit Training
Participants in this arm will include qualified healthcare prescribers (MDs, DOs, PAs, NPs, etc.) and staff who treat patients with Type 2 diabetes in primary care settings who will receive in depth training using a study-developed prescriber toolkit. The toolkit covers important information including current clinical practice guidelines, eligibility criteria, provider documentation requirements and scripts for discussing CGM use with their patient population. The impact of the training will be evaluated by examining changes in CGM prescription rates for patients with Type 2 diabetes seen in primary care before and after the training is delivered. Secondarily, Participants will be surveyed pre- and post-training to elicit prescribing knowledge and attitudes towards CGM use.
干预措施: CGM Toolkit Prescriber Training (Behavioral)
Healthcare Prescribers Not Exposed to CGM Prescriber Toolkit Training
Participants in this arm are prescribers (MDs, DOs, PAs, NPs, etc.) and staff who will NOT receive in depth training using a study-developed prescriber toolkit.
结局指标
主要结局
CGM prescription rates
时间窗: From training until month 6
Determine if the proportion of patients with T2D who are prescribed CGM increases following the intervention as compared to pre-intervention data
次要结局
- HCP/Staff Knowledge and Attitudes Towards CGM Use & Prescribing Behavior in Target Population(Pre-training to Month 3)
- Effect of CGM Prescription on HgbA1C(Receipt of CGM Prescription to Month 6)
- Effect of CGM on Individual Diabetes Distress Among Patients with T2D(Receipt of CGM Prescription to month 6)
- Challenges and Facilitators to CGM Uptake in Patients with T2D(Receipt of CGM to Month 6)