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Impact of CMS Reimbursement Policy Supporting Care Coordination in Louisiana

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ClinicalTrials.gov Identifier: NCT03136471
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Lizheng Shi, Tulane University

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.

Condition or disease
Diabetes Mellitus, Type 2 Chronic Disease

Detailed Description:

The first aim is to evaluate the barriers (e.g., racial and ethnic disparities) 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 aim is the health and economic impacts of the CMS care coordination reimbursement to improve health outcomes: glycemic control, CVD risk reduction, medication adherence, patient-reported outcomes (PRO), and health care utilization. Data extraction from the Louisiana Clinical Data Research Network (LaCDRN). De-identified data from EMR includes birth year, gender, race, state of residency, 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.


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Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Experiments of the Impact of Population-Targeted Health Policies to Prevent Diabetes and Its Complications
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort
EMR data extraction

EMR Data extraction from the Louisiana Clinical Data Research Network (LaCDRN). The Louisiana Clinical Data Research Network (LaCDRN) data will be requested, including patients' records of pharmacy, inpatient, outpatient and lab results from January 01, 2016 to December 31, 2021. It is a retrospective data analysis without interaction with any participants. All data is de-identified and the study participants will not be contacted in any way.

Inclusion criteria: Patients with type 2 diabetes, whose age>=18 years old will be extracted from database of LaCDRN.

Exclusion criteria: Patients without type 2 diabetes or age<18 years old.

Healthcare Professionals

Healthcare professionals (physician, nurse) will be randomly selected from LaCDRN partner health system. An email will be distributed to the registered clinicians at partner health systems.

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

Patients with diabetes who are a members of Diabetes Advisory Group or partner LaCDRN health system will be contacted via email, letter or phone call.

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.

LaCDRN partner health system's medical directors
Face-to-face semi-structured interviews will be used to explore organizational cultures, their social architecture, resources, capacity, communication networks, assess barriers, and refine the data collection for the assessing the RE-AIM framework. The one time interview will take 1 hour. A 10 minutes questionnaire of Diabetes care coordination readiness assessment (DCCRA) will be emailed to them annually during entire 5 years of study period.
PROMIS® survey

Patients for PROMIS® survey (National Institutes of Health's Patient-Reported Outcome Measurement Information System Global Health Measures). Patients will be administered the surveys at the point-of-care visit (in exam rooms) using REACHnet's tablet-based application.

Inclusion criteria:

  • All patients age 18+ who registered at REACHnet.
  • Able to provide informed consent

Exclusion criteria: patients who do not provide inform consent or age<18 years old.

PACIC+ survey

Patients for PACIC+ survey (Group Health Research Institute's Patient Assessment of Care for Chronic Conditions+). Patients will be administered the surveys at the point-of-care visit (in exam rooms) using REACHnet's tablet-based application.

Inclusion criteria:

  • All patients age 18+ with a Diabetes diagnosis and who registered at REACHnet.
  • Able to provide informed consent

Exclusion criteria: patients who do not provide inform consent or without diabetes diagnosis or age<18 years old




Primary Outcome Measures :
  1. Change in use of CMS care coordination reimbursement code over 5 years [ Time Frame: 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.

  2. Change in glycemic control over 5 years [ Time Frame: 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%.

  3. Change in healthcare utilization over 5 years [ Time Frame: 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.

  4. Change in patient satisfaction over 5 years [ Time Frame: 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.

  5. Change in status of received diabetes care over 5 years [ Time Frame: 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.

  6. Change in patient reported physical health over 5 years [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136471


Contacts
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Contact: Shuqian Liu, PhD 504-988-1939 sliu9@tulane.edu

Locations
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United States, Louisiana
Tulane School of Public Health and Tropical Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Shuqian Liu, PhD    504-988-1939    sliu9@tulane.edu   
Sponsors and Collaborators
Tulane University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Lizheng Shi, PhD Tulane University

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Responsible Party: Lizheng Shi, Principal Investigator, Tulane University
ClinicalTrials.gov Identifier: NCT03136471     History of Changes
Other Study ID Numbers: 16-906810
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Chronic Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes