Improving Outcomes in Patients With Comorbid T2DM and ASCVD: Population Health Management Interventions Supporting Guideline-recommended SGLT2i and GLP-1 RA Medications
试验速览
- 阶段
- 不适用
- 发起方
- Humana Inc.
- 入组人数
- 4,197
- 试验地点
- 2
- 主要终点
- Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
研究概览
简要总结
This is an educational outreach to patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) and their primary care and specialist providers to improve use of guideline-recommended treatments, specifically sodium-glucose cotransporter 2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications.
详细描述
Patients with type 2 diabetes mellitus, a history of atherosclerotic cardiovascular disease, without use of select guideline-recommended medications in the previous year will be identified from administrative claims. Primary care providers will be identified, randomly selected and randomized to the intervention arm or control arm. All eligible patients for that provider will be included. The patient's specialist providers (cardiologist and/or endocrinologist, as applicable) will be identified and contacted. The intervention will include a multi-faceted strategy to support providers in the care of their patients by sharing recent guideline-based treatment recommendations and provide patients with information regarding ways to reduce their cardiovascular risk. Outreach will occur for all patients and providers randomized for the intervention - there will be no active enrollment or recruitment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2DM defined as ≥2 outpatient diagnoses of T2DM in any position on separate days; OR ≥1 inpatient diagnosis T2DM in any position; OR ≥1 outpatient diagnosis in any position AND ≥1 medication claim for T2DM
- •≥1 diagnosis code for ASCVD (coronary artery disease diagnoses or procedures, cerebrovascular disease, peripheral artery disease of atherosclerotic origin) on any claim type in any position within the 24-month period prior to identification
- •Enrolled in a Humana Medicare Advantage Prescription Drug plan with ≥12 months pre-identification continuous enrollment (no more than a 31 day gap) as of the identification date and currently enrolled as of the identification date
- •Age 18-85 years at time of identification
- •Patients residing in Kentucky (KY), West Virginia (WV), Pennsylvania (PA), and 6 counties in south New Jersey (NJ) (Burlington, Camden, Cumberland, Gloucester, Mercer, Salem) (United States)
- •Primary care providers of the identified patients
排除标准
- •≥1 diagnosis or procedure code for end-stage kidney disease, renal transplant, dialysis or kidney failure
- •Any hospice or long-term care residence
- •≥1 code for pregnancy/childbirth
- •Patients with any use of SGLT2i or GLP-1 RA medications in the pre-identification period
- •Patients without an attributed primary care provider
- •Patients on do not contact lists
- •Patients without valid addresses and telephone numbers
- •Patients with ≥1 diagnosis for type 1 diabetes pre-identification
- •Primary care providers
- •Providers on do not contact lists
- •Providers without valid fax/mailing address and phone number
- •Providers with <3 or >50 eligible patients
结局指标
主要结局
Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
时间窗: 6-months
Percentage of individuals with T2D \& ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products
次要结局
- Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data(12-months)
- Percentage of individuals adherent to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data(6-months)
- Percentage of individuals persistent to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data(6-months)
- Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products, based on administrative claims data(12-months)
研究者
Alexjandro Daviano
Research Consulting Lead
Humana Inc.