Clinical trial NCT03136471: Impact of CMS Reimbursement Policy Supporting Care Coordination in Louisiana
Official title: Natural Experiments of the Impact of Population-Targeted Health Policies to Prevent Diabetes and Its Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Chronic Disease
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2017-05-02
Enrollment: 22242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes Healthcare professionals who treat diabetes patients, medical directors at Louisiana Clinical Data Research Network (LaCDRN) affiliated clinics, patients with diabetes, patients who are registered with REACHnet, and medical records from LaCDRN affiliated clinics.

Brief summary: 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.

Detailed description: 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.

Aim 2: Compare diabetes control and continuity of care between patients with and without utilization of telehealth. We hypothesize better diabetes management among Medicare patients with telehealth versus without.

Eligibility criteria: Healthcare professionals (physician, nurse) will be randomly selected from LaCDRN partner health system.

* Inclusion criteria: physicians and nurses who treat diabetes patients and work at clinic settings within LaCDRN network and consent to participate the study.
* Exclusion criteria: physicians and nurses who do not treat diabetes patients or not work at clinic settings within LaCDRN network; refuse to participate the study.

Patients for qualitative study:

* Inclusion criteria: Diabetes patients who consent to participate the study; Age 65+; Diagnosis code for diabetes in the last 2 years; Diagnosis code for at least one additional chronic condition in the last 2 years.
* Exclusion criteria: age\<65; patient with diabetes without other chronic conditions.

Primary outcomes:
measure: Change in use of CMS care coordination reimbursement code over 5 years
timeFrame: 5 years
measure: Change in glycemic control over 5 years
timeFrame: 5 years
measure: Change in healthcare utilization over 5 years
timeFrame: 5 years
measure: Change in patient satisfaction over 5 years
timeFrame: 5 years
measure: Change in status of received diabetes care over 5 years
timeFrame: 5 years
measure: Change in patient reported physical health over 5 years
timeFrame: 5 years
measure: Glycemic Control (HbA1c) for Telehealth visits for COVID-19 patients
timeFrame: Baseline, post-baseline period within 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane School of Public Health and Tropical Medicine
state: Louisiana
Study officials:
affiliation: Tulane University
name: Lizheng Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References: