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临床试验/NCT03136471
NCT03136471已完成不适用

Natural Experiments of the Impact of Population-Targeted Health Policies to Prevent Diabetes and Its Complications

Tulane University1 个研究点 分布在 1 个国家目标入组 22,242 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22,242
试验地点
1
主要终点
Change in glycemic control over 5 years

研究概览

简要总结

Investigators propose to use a natural experiment design to examine the impacts of the new CPT code (99490) for chronic care management on health outcomes. The Investigators will collaborate with partners in the Louisiana Clinical Data Research Network (LaCDRN) who serve more than 90,000 patients with type 2 diabetes mellitus in Louisiana to examine impacts of the CMS reimbursed care coordination. Now, LaCDRN is renamed as Research Action for Health Network (REACHnet). Patient and stakeholder engagement will be planned and implemented across all phases of this natural experiment. This project will examine outcome differences created by the policy change in a natural experiment framework. The analyses will utilize the RE-AIM framework to identify the critical elements of the programs that will enhance the reach, effectiveness, adoption, implementation, and maintenance of these strategies in the diverse LaCDRN diabetes populations.

PCORI Proposal COVID-19- Related Enhancement for Existing Research:

The proposed enhancement will contribute timely information to address two important implications of the coronavirus pandemic:

  1. Disparities in continuity of care and
  2. Health systems' responsiveness in terms of telehealth delivery for high risk populations.

The enhancement builds upon our current project by further examining effects of CMS payment innovations to expand remotely delivered care. Our proposed study is a rapid assessment of telehealth services, using an existing "learning health system" infrastructure to provide timely, actionable evidence to inform telehealth service provision during the pandemic and recovery.

详细描述

The first aim is to evaluate the barriers and facilitators for the RE-AIM dimensions as related to the new CMS chronic care management code overall and within each of the health systems. The qualitative study will be used. Focus group interview will be conducted among patients, healthcare professionals and stakeholders. A variety of qualitative techniques will be used to collect data using key informant interviews among organization leaders of LaCDRN partners to assess the organizational cultures, their social architecture, resources, capacity, and communication networks. Face-to-face semi-structured interviews will be used to explore these domains, assess barriers, and refine the data collection for the assessing the RE-AIM framework. Further, semi-structured interviews will provide data to inform the refinement of study outcomes and ensure organizational, cultural, and health-literacy appropriateness. Focus groups will be audiotaped with the written consent of each participant, and each tape will be transcribed verbatim and transcripts will be reviewed and edited by the facilitators for accuracy. Inter-coder reliability will be examined. Interview transcripts will be imported into NVivo 10 software (QSR International, Burlington, MA). Codes and concepts identified in preliminary review will be refined, extended, and cross-referenced. Coded texts will be structured into taxonomies and transformed into a matrix format so that responses and concepts can be compared across respondent groups. Finally, taxonomies and matrices will be summarized by similarities and contrasts to form overarching themes and dimensions. We will use an iterative technique until theoretical saturation, the point at which no additional major themes emerge, is reached. Diabetes care coordination readiness assessment will be conducted with LaCDRN partner health system's medical directors (organizational).

The second one is the health and economic impacts of the NFFCCM to improve health outcomes: glycemic control, CVD risk reduction, medication adherence, patient-reported outcomes (PRO), and health care utilization. Data extraction from the REACHnet. De-identified data from EMR includes birth year, gender, race, state of residency, zip-codes, medical history, lab results and prescriptions. All data comply with the Health Insurance Portability and Accountability Act (HIPAA).

This proposed research is significant because it is the first natural experiment to test an ongoing CMS reimbursement policy on diabetes care in Louisiana. The study questions and study outcomes will be patient-centered, and will generate urgently needed data on effective, practical, and sustainable population-targeted strategies aimed at reducing diabetes-related disease burden in Medicare-eligible populations. Further dissemination and scale-up efforts will create large return on multiple health systems and non-CMS populations.

PCORI Proposal COVID-19- Related Enhancement for Existing Research Aims:

Aim1: Examine facilitators and barriers to uptake, adoption, and implementation of telehealth services among Medicare patients with diabetes from health systems', providers' and patients' perspectives. With the substantial increase in telehealth encounters starting in early March 2020, we hypothesize disparities in adoption and implementation of telehealth at health system, provider and patient levels. For example, our current project has identified significant variations in NFFCCM implementation across three health systems in Louisiana. For the enhancement, we intend to examine variations in health systems' implementation of Medicare-reimbursable telehealth services, which may not mirror the variations we observed for NFFCCM given the dramatically different context of the current pandemic.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in glycemic control over 5 years

时间窗: 5 years

Over 5 years diabetes patients extracted from the EMR will be analyzed to see if patients are able to achieve glycemic control by having a Hemoglobin A1c \<7% and maintain staying below 7.0%.

Change in use of CMS care coordination reimbursement code over 5 years

时间窗: 5 years

Over 5 years the utilization of the CMS care coordination reimbursement code will be analyzed to see if there is any change in how often the code is used.

Change in healthcare utilization over 5 years

时间窗: 5 years

Records from the EMR will be assessed by counting the number of outpatient visits, number of inpatient visits, and number of emergency room visits, to determine if there has been a change in the utilization of the healthcare system.

Change in patient satisfaction over 5 years

时间窗: 5 years

Patients registered in REACHnet, diagnosed with Type 2 diabetes, and complete the PACIC+ survey will be analyzed to see if there is a change in patient satisfaction over 5 years.

Change in status of received diabetes care over 5 years

时间窗: 5 years

Patients registered in REACHnet, diagnosed with Type 2 diabetes, and complete the PACIC+ survey will be analyzed to see if there is a change in the patient's status of received diabetes care over 5 years.

Change in patient reported physical health over 5 years

时间窗: 5 years

Patients registered in REACHnet and complete the PROMIS survey will be analyzed to see if there is a change in patient reported physical health score over 5 years.

Glycemic Control (HbA1c) for Telehealth visits for COVID-19 patients

时间窗: Baseline, post-baseline period within 12 months

Measured before and within 12 months after 03/06/2020

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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