Diabetes Mellitus, Type 2NCT03136471
Impact of CMS Reimbursement Policy Supporting Care Coordination in Louisiana
An observational study of Diabetes Mellitus, Type 2 and Chronic Disease, run by Tulane University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Chronic Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 22,242 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane School of Public Health and Tropical Medicine
New Orleans, Louisiana, 70112
About this study
Official title: Natural Experiments of the Impact of Population-Targeted Health Policies to Prevent Diabetes and Its Complications
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:
Read more
The proposed enhancement will contribute timely information to address two important implications of the coronavirus pandemic:
- Disparities in continuity of care and
- 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Chronic Disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| Telehealth Services using HCPCS/CPT for COVID-19 Patients | Study population with versus without telehealth services. Telehealth services using the HCPCS/CPT codes will be defined in the following categories: Medicare telehealth visits (CPT codes: 99201-99215; HCPCS codes: G0425-G0427, G0406-G0408), virtual check-in (HCPCS codes: G2010, G2012), and e-visits (CPT codes: 99421-99423, HCPCS codes: G2061-G2063). Propensity score-matching will be used to ensure comparison groups are comparable at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in use of CMS care coordination reimbursement code over 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.
Measured: 5 years
Change in glycemic control over 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%.
Measured: 5 years
Change in healthcare utilization over 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.
Measured: 5 years
Change in patient satisfaction over 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.
Measured: 5 years
Change in status of received diabetes care over 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.
Measured: 5 years
Change in patient reported physical health over 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.
Measured: 5 years
Glycemic Control (HbA1c) for Telehealth visits for COVID-19 patients
Measured before and within 12 months after 03/06/2020
Measured: Baseline, post-baseline period within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startJan 2017
- Primary completionDec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22,242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Lizheng Shi, PhD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136471
- Sponsor's protocol ID
- 16-906810
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2017
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Walker B, Stoecker C, Shao Y, Nauman E, Kabagambe EK, Shi L. Predictors of Telehealth Utilization and Subsequent Inpatient Stays and Emergency Visits During the COVID-19 Pandemic Among Patients with Type 2 Diabetes: Evidence from Louisiana. Telemed J E Health. 2024 Jan;30(1):278-283. doi: 10.1089/tmj.2022.0509. Epub 2023 Jul 3.
PubMed 37405746
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Experiments of the Impact of Population-Targeted Health Policies to Prevent Diabetes and Its Complications
- ClinicalTrials.gov ID
- NCT03136471
- Acronym / sponsor ID
- 16-906810
- Conditions
- Diabetes Mellitus, Type 2, Chronic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,242 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Disparities in continuity of care and
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
| Telehealth Services using HCPCS/CPT for COVID-19 Patients | – | –Study population with versus without telehealth services. Telehealth services using the HCPCS/CPT codes will be defined in the following categories: Medicare telehealth visits (CPT codes: 99201-99215; HCPCS codes: G0425-G0427, G0406-G0408), virtual check-in (HCPCS codes: G2010, G2012), and e-visits (CPT codes: 99421-99423, HCPCS codes: G2061-G2063). Propensity score-matching will be used to ensure comparison groups are comparable at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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%.
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.
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.
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.
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.
Glycemic Control (HbA1c) for Telehealth visits for COVID-19 patients
Time frame: Baseline, post-baseline period within 12 months
Measured before and within 12 months after 03/06/2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Derived from this study: PubMed 37405746Walker B, Stoecker C, Shao Y, Nauman E, Kabagambe EK, Shi L. Predictors of Telehealth Utilization and Subsequent Inpatient Stays and Emergency Visits During the COVID-19 Pandemic Among Patients with Type 2 Diabetes: Evidence from Louisiana. Telemed J E Health. 2024 Jan;30(1):278-283. doi: 10.1089/tmj.2022.0509. Epub 2023 Jul 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lizheng Shi, PhD principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Chronic Disease, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in use of CMS care coordination reimbursement code over 5 years (time frame: 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.