Results Summary
What was the research about?
Type 2 diabetes is a health problem that causes blood sugar levels to rise. Diabetes causes many health problems and can be hard to manage. Clinicians, like doctors and nurses, may need to spend extra time planning care for these patients. This kind of planning, called chronic care management, or CCM, may include working with other doctors and following up with patients online or by phone outside of regular office visits. In 2015, Medicare started to pay clinicians for CCM services.
In this study, the research team wanted to learn whether CCM leads to better health outcomes for patients with diabetes. They compared health records for patients who received CCM with patients who didn’t receive it.
What were the results?
Compared with the group of patients who didn’t receive CCM, the group of patients who received CCM had lower:
- Average blood sugar levels
- Average body weight
- Average blood pressure
- Average cholesterol
- Percentage of patients with overweight
- Percentage of patients with hypertension
The group of patients who received CCM also had an increase in doctor’s office visits and a decrease in hospital and emergency room visits. The two groups didn’t differ in the percentage of patients who had serious heart problems, like a heart attack or stroke.
Who was in the study?
The study included health records from 22,347 patients with type 2 diabetes. All received care at one of three health systems in Louisiana between January 2013 and February 2020. Of these patients, 39 percent were Black, and 3 percent were Hispanic or Latino. The average age was 72, and 55 percent were women.
What did the research team do?
The research team looked at health records for patients to see if they received CCM. They then looked at patients’ health records for the two years before and after they received CCM. The team compared this group of patients to a group of patients with similar traits who didn’t receive CCM.
Patients with type 2 diabetes, doctors, and insurers helped design the study.
What were the limits of the study?
Because of the study design, it isn’t possible to know for sure if the changes in patient health happened because of CCM or something else that occurred at the same time. The study included patients from three health systems in Louisiana. Results may differ for patients in other states.
Future research could look at the impact of CCM in other states.
How can people use the results?
Policy makers can use the results to understand how CCM affects patient health.
| How this project fits under PCORI’s Research Priorities The research reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®). |
Professional Abstract
Objective
To compare the effects of receiving non-face-to-face chronic care management (NFFCCM) versus not receiving it, on health outcomes and healthcare utilization among patients with type 2 diabetes
Study Design
| Design Element | Description |
|---|---|
| Design | Quasi-experimental study |
| Population | EHRs for 22,347 patients with type 2 diabetes receiving care at three health systems in Louisiana participating in REACHnet, a PCORnet® Clinical Research Network |
| Interventions/ Comparators |
|
| Outcomes |
Primary: glycemic control measured by HbA1c Secondary: BMI; blood pressure; LDL cholesterol; healthcare use (outpatient visits, hospitalizations, ED visits); diabetes-related health complications; major cardiovascular events; overweight; stage 2 hypertension |
| Timeframe | 2-year follow-up for primary outcome |
In 2015, Medicare started to reimburse healthcare providers for NFFCCM, including clinical time spent coordinating care for patients outside of normal office visits. This quasi-experimental study compared type 2 diabetes health outcomes and healthcare utilization among patients who did and did not receive NFFCCM.
The study included electronic health records (EHRs) for 22,347 patients with type 2 diabetes who received care at one of three health systems in Louisiana between January 2013 and February 2020. Of these patients, 39% were Black, and 3% were Hispanic or Latino. The average age was 72, and 55% were female.
Researchers reviewed medical billing codes in patients’ EHRs to determine whether they received NFFCCM. The EHR data were from PCORnet®, the National Patient-Centered Clinical Research Network. Researchers then looked at EHR data from two years before and after the first date that patients received NFFCCM. Researchers used propensity score weighting and regression adjustment to ensure treated and untreated patients were similar in terms of age, race, ethnicity, chronic conditions, healthcare utilization, and type 2 diabetes clinical outcomes.
Patients with type 2 diabetes, clinicians, and health insurers helped design the study.
Results
Compared with the group of patients who did not receive NFFCCM, the group of patients who received NFFCCM had a reduction in:
- Mean hemoglobin A1c (HbA1c) (p<0.001)
- Mean body mass index (BMI) (p=0.016)
- Mean systolic blood pressure (p<0.001)
- Mean low-density lipoprotein (LDL) cholesterol (p<0.001)
- The percentage of patients with overweight (p<0.01)
- The percentage of patients with stage 2 hypertension (p<0.001)
Receiving NFFCCM was also associated with an increase in outpatient visits (p<0.001) and a decrease in hospitalizations (p<0.001) and emergency department (ED) visits (p=0.005). Receiving NFFCCM was not significantly associated with major cardiovascular events.
Limitations
The study was not randomized, and the regression and propensity weighting procedures may not have adjusted for all possible factors influencing outcomes. The study included patients from three health systems in Louisiana, a state with a higher proportion of patients with type 2 diabetes. Results may differ for patients in other states.
Conclusions and Relevance
In this study, patients receiving NFFCCM showed improvements in mean HbA1c, BMI, blood pressure, and cholesterol and had fewer hospitalizations and ED visits compared with patients who did not receive NFFCCM.
Future Research Needs
Future research could examine the effect of NFFCCM on type 2 diabetes outcomes in settings outside Louisiana.
| How this project fits under PCORI’s Research Priorities The research reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®). |
COVID-19-Related Study
Use of Telehealth for Patients with Type 2 Diabetes during the COVID-19 Pandemic
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
Patients with chronic health problems such as type 2 diabetes often require regular visits with their doctors to manage their illness. During the COVID-19 pandemic, Medicare made it easier for patients to get care using telehealth. Telehealth is a way to provide care to patients remotely using phone, video, or other devices.
In this study, the research team wanted to learn how the use of telehealth affected health outcomes for patients with type 2 diabetes during the pandemic. They compared a group of patients who received telehealth during the pandemic with a group of patients who didn’t receive it. The team also interviewed patients, doctors, and health system staff about their experience with telehealth.
What were the results?
Compared with the group of patients who didn’t receive telehealth, the group of patients who did had:
- Lower average blood sugar
- Lower average cholesterol
- Lower average blood pressure
- Fewer patients with obesity or overweight
- Fewer patients who received care from the same healthcare provider consistently across visits
- More patients who had a hospital stay
The number of emergency room visits didn’t differ between groups.
In interviews, most patients said that telehealth was convenient and made it easy to get care. But patients with complex health problems still needed in-person visits. Telehealth only helped coordinate care for these patients. Problems with technology was the biggest barrier to telehealth. These issues ranged from patients not knowing how to use technology to not having internet access.
Who was in the study?
The study included health records from 31,654 patients with type 2 diabetes. All had Medicare insurance. Patients received care from one of three health systems in Louisiana between March 2018 and February 2021. Among patients, 54 percent were non-Hispanic White, 41 percent were non-Hispanic Black, 3 percent were White Hispanic, and 3 percent were another race or ethnicity. Also, 81 percent were ages 65 and older, and 59 percent were women.
What did the research team do?
The research team looked at health records to identify a group of patients with type 2 diabetes who received telehealth. Then they identified a group of patients with similar traits, such as age, race, or types of health problems, who didn’t receive telehealth. The team compared patients’ blood sugar, cholesterol, blood pressure, weight, and use of health care. The team also interviewed 18 patients, doctors, and health system staff.
Patients with diabetes, clinicians, and insurers helped design the study.
What were the limits of the study?
The study included patients from Louisiana, a state with a high percentage of patients with type 2 diabetes. Results may differ for patients who live in other states.
How can people use the results?
Health systems can use the results when considering the use of telehealth to manage care for patients with type 2 diabetes.
| How this project fits under PCORI’s Research Priorities The research reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®). |
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
Patients with chronic conditions like type 2 diabetes often require regular visits with their doctors to manage their disease. In response to the COVID-19 pandemic, the Centers for Medicare & Medicaid Services made it easier for patients with Medicare to receive care via telehealth. However, it is unknown how telehealth affects the management of type 2 diabetes.
Objective
(1) To compare the management of type 2 diabetes and related outcomes among patients with type 2 diabetes who did and did not receive telehealth services during the COVID-19 pandemic; (2) To determine barriers and facilitators to using telehealth services
Study Design
| Design Element | Description |
|---|---|
| Design | Quasi-experimental study, qualitative study |
| Population |
Quasi-experimental study: EHRs from 31,654 patients with type 2 diabetes from three health systems in Louisiana participating in REACHnet, a PCORnet® Clinical Research Network (CRN) Qualitative study: Interviews with 18 patients, providers, and health system staff |
| Outcomes |
Quasi-experimental study: management of type 2 diabetes (including measures of HbA1c, low-density lipoprotein cholesterol, and blood pressure); BMI; inpatient or emergency department visits related to diabetes complications; continuity of care indices Qualitative study: barriers and facilitators to using telehealth services |
| Data Collection Timeframe | March 2018–February 2021 |
This quasi-experimental study compared the effect of the receipt of telehealth services during the COVID-19 pandemic among patients with type 2 diabetes on outcomes related to diabetes management.
From electronic health records (EHRs), researchers identified patients with type 2 diabetes who received telehealth services during the COVID-19 pandemic. To select a comparison group of patients who did not receive telehealth services, researchers used propensity score matching and patient characteristics such as age, race, chronic conditions, healthcare use, and type 2 diabetes biomarkers, such as hemoglobin A1c (HbA1c) levels.
This study included EHRs for 31,654 patients with type 2 diabetes who received care at one of three health systems in Louisiana between March 2018 and February 2021. Among patients, 54% were non-Hispanic White, 41% were non-Hispanic Black, 3% were White Hispanic, and 3% were another race or ethnicity. Also, 81% were ages 65 and older, and 59% were female.
The qualitative study explored barriers and facilitators to using telehealth services. Researchers interviewed 18 patients, clinicians, and health system staff about their experience with telehealth during this period.
Patients with diabetes, clinicians, insurers, and researchers helped design the study.
Results
Compared with patients who did not receive telehealth services, patients who received telehealth services had:
- Lower mean HbA1c levels (p<0.001)
- Lower mean cholesterol (p=0.002)
- Lower mean blood pressure (p=0.009)
- Higher probability of having a normal body mass index (BMI) (p=0.008)
- Lower scores on continuity of care indices (p<0.001)
- Higher probability of an inpatient admission (p<0.001)
The number of emergency department visits did not differ significantly between groups.
In interviews, participants stated that telehealth made it convenient to get care. Patients with complex health conditions still required in-person visits; telehealth served only as a mechanism for continuity of care for these patients. Patients and clinicians identified technology problems as the most significant barrier to telehealth, with problems ranging from understanding how to use technology to not having reliable internet access.
Limitations
The study included patients from three health systems in Louisiana, a state with a high proportion of patients with type 2 diabetes. Results may differ for patients who live in other states.
Conclusions and Relevance
Telehealth use during the COVID-19 pandemic was associated with improvements in type 2 diabetes-related health outcomes and increases in inpatient admissions.
| How this project fits under PCORI’s Research Priorities The research reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®). |
Peer Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers had difficulty interpreting the study results which were presented in coefficients that did not clearly indicate the magnitude or importance of the results. The researchers removed coefficient estimates from the results tables and focused those tables on odds ratios, which are easier to interpret.
- The reviewers questioned the researchers’ interpretation that an improvement of 0.08% in measures of glycated hemoglobin was clinically meaningful given that the referenced survey of physicians indicated that doctors look for a 0.5% change in glycated hemoglobin to consider the change clinically meaningful. The researchers moderated their conclusions related to their modest results on this measure.
- The reviewers asked the researchers to consider further the contextual factors for this study, including how the COVID-19 pandemic changed the trajectory of the use of telehealth in ambulatory medicine. The researchers primarily tried to look at urban versus rural clinical settings as context for the study outcomes but found that the study population primarily came from urban areas.
- The reviewers noted that this COVID-19 enhancement report referred specifically to using the RE-AIM framework (i.e., Reach, Effectiveness, Adoption, Implementation, Maintenance) but did not refer back to this framework when putting their results in context. The researchers added a table to their discussion where they synthesized their findings into the Reach, Effectiveness, Adoption, Implementation, and Maintenance categories of the RE-AIM framework.
- The reviewers pointed out that in the section on treatment response heterogeneity, the researchers appeared to be reporting sub-group differences—that is, the difference in outcomes for two different ethnic groups who used telehealth. The researchers revised the report to clarify that they did in fact examine treatment response heterogeneity; they analyzed the difference between patients who did and did not use telehealth and compared whether those differences were consistent across different sub-groups.
Final Enhancement Report
View this COVID-19 study's final enhancement report.
DOI - Digital Object Identifier: 10.25302/10.2022.NEN.150832257-C19
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers expressed concern that the multiple outcomes, including several cut-points for glycated hemoglobin (also known as hemoglobin A1c or A1c), would lead to significant outcomes that could be attributed to chance. The reviewers noted that the study protocol focused on fewer comparisons and asked why the additional cut-points were added and whether these were predetermined or added post-hoc. The researchers clarified that their primary outcome was the measure of A1c under 7 percent, but that they had included post-hoc measurement at 9 percent or 8 percent, as well as several cut-points for the size of the difference in A1c from baseline to follow-up.
- The reviewers questioned one of the results of the study, indicating that there was a substantial increase in outpatient visits that were not focused on care management in the patients enrolled in the care management program, because this result did not seem to be consistent between electronic health records and claims data. The researchers acknowledged that this finding was not consistent across databases and this difference was probably attributable to how non-case management visits were documented.
- The reviewers also asked the researchers to clarify some of the methods that were used and how some of the analyses were performed, particularly with variable follow-up on the outcome measures. The researchers explained their methods further and particularly how they accounted for differences in the follow-up period, standardizing the number of months for follow-up if the outcome variable was sensitive to the time between baseline and follow-up.
- The reviewers commented on the application of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) to this research and especially that the researchers did not seem to apply this framework in the discussion of study results. The researchers added a table to the discussion that synthesized the results into each of the RE-AIM periods.
- The reviewers questioned the researchers’ conclusion that the modest decreases in mean A1c were clinically meaningful given that this was based on survey results in a paper that concluded the opposite. The researchers added text to the report indicating that the modest differences are probably not clinically meaningful, but it is encouraging that patients with higher A1c at baseline showed the greatest reduction by follow-up.