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A Patient-Centered PaTH to Addressing Diabetes

A Patient-Centered PaTH to Addressing Diabetes: Impact of State Health Policies on Diabetes Outcomes and Disparities and Enhancement Study: Telemedicine Access and Severe Disease Outcomes in Patients With Diabetes and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02788903
Enrollment
2622164
Registered
2016-06-02
Start date
2016-03-31
Completion date
2021-05-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Diabetes, Obesity

Keywords

Obesity Counseling, telemedicine

Brief summary

The overarching goal of this proposal is to understand the comparative effectiveness of obesity counseling as covered by CMS in improving weight loss for adults either with or at high risk of type 2 diabetes. CMS and most insurers now include obesity screening and counseling benefits, with no cost sharing to patients. Since overweight patients are at highest risk for diabetes, improved weight management services could prevent diabetes and its negative health outcomes. Beneficiaries with obesity are eligible for up to 20 face-to-face visits for weight counseling in the primary care setting. The investigators propose comparing weight and diabetes outcomes in three states using EHR and claims data before and after this policy was implemented by leveraging the novel infrastructure of the Patient-Centered Outcomes Research Institute-funded PaTH Clinical Data Research Network. Following developments during the COVID-19 pandemic, the investigators further plan to leverage our study infrastructure across five health systems to understand the comparative effectiveness of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes and how these approaches impact the subgroup of patients with COVID-19.

Detailed description

Aim 1: Evaluate the impact of universal preventive service coverage for obesity screening and counseling on weight loss, diabetes incidence, and diabetes outcomes, in patients with diabetes or at high risk for diabetes (defined by body mass index (BMI) ≥ 25). The investigators will determine how the annual probability of receiving obesity and/or nutritional counseling (as defined by Current Procedural Terminology (CPT) code) changed pre- and post-policy across all insurers in a cohort of patients with diabetes and at high risk for diabetes. The investigators hypothesize that individual patients are more likely to receive counseling following coverage implementation. Further, the investigators hypothesize that patients who receive a greater number of face-to-face visits will have greater weight loss compared to those who receive fewer visits. Aim 2: Compare patient weight loss and diabetes-related outcomes among those who receive obesity screening and counseling to those who do not, following implementation of preventive service coverage. The investigators will examine post-policy impact of obesity screening and counseling in a cohort of patients with diabetes and at high risk for diabetes. Specific outcomes to be examined include weight loss, diabetes incidence, and diabetes outcomes (including hemoglobin A1c, controlled blood pressure, use of a statin medication). Further, the investigators will determine patient characteristics, including demographics (age, race/ethnicity, rurality), and practice characteristics, including provider type, and their impact on receiving/providing obesity screening and counseling. Understanding patient and practice characteristics most likely to engage in obesity counseling can identify best practices and inform how to increase engagement by both patients and providers. Aim 3: To understand the impact of telemedicine access (telephonic and/or virtual visits) compared to no telemedicine visits for outpatient care for patients with, or at risk of, type 2 diabetes during the pandemic on patient-centered outcomes including hemoglobin A1c and healthcare utilization, with sub-group analysis of patients with COVID-19; Aim 4: To evaluate the risk of severe COVID-19 disease (defined by hospitalization and mortality) in patients with diabetes and/or elevated BMI, with a focus on identifying modifiable factors (i.e., medication use, treatment timeline/location, chronic comorbid conditions) and associated with improved outcomes to inform immediate intervention and future study.

Interventions

OTHERWeight Counseling

This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Patients with Diabetes * Ages 18 and older * Indication of Type 2 Diabetes as defined using a clinically validated algorithm: type 2 diabetes mellitus on the problem list, diabetes-specific medications, hemoglobin A1c (HbA1c) results \> 6.5%, or one inpatient diagnosis code or two out-patient diagnosis codes for type 2 diabetes (ICD-9 codes 250.xx) * patients who have either: (1) visited a primary care doctor from one of the PaTH health systems in the past 3 years (since January 1, 2012), or (2) for whom claims data are available Patients with Pre-Diabetes (At risk): * Ages 18 and older * BMI \> 25 kg/m2 * patients who have either: (1) visited a primary care doctor from one of the PaTH health systems in the past 3 years (since January 1, 2012), or (2) for whom claims data are available Patients with COVID-19: * Ages 18 and older * Patients with a diagnosis of COVID-19

Exclusion criteria

* Patients under the age of 18

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Diagnosed With COVID-19 Who Were Hospitalized1 yearNumber of Participants Diagnosed with COVID-19 Who Were Hospitalized in both the diabetes and pre-diabetes cohorts.
Number of Participants Who Used the Intensive Behavioral Therapy (IBT) Service11 yearsNumber of patients who utilized IBT services was assessed in both the diabetes and pre-diabetes cohorts using code G0447.
Change in Weight During Counseling Program11 yearsWeight change during counseling and/or % of weight change during program and maintained over remaining time period will be assessed in both the diabetes and pre-diabetes cohorts.
Hemoglobin A1c1 yearA1c of patients who received a telehealth visit and COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.

Secondary

MeasureTime frameDescription
Number of Patients Who Received Telehealth and Were Hospitalized With a COVID-19 Diagnosis1 yearNumber of patients who received telehealth and were hospitalized with a COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.
Number of Patients With Uncontrolled Blood Pressure11 yearsThe number of patients with uncontrolled blood pressure (SBP \> 140, DBP \> 90 all the time, defined for 1-year prior to first IBTb visit, and 1-year after) in the diabetes and pre-diabetes cohorts
Number of Patients With Uncontrolled Hemoglobin A1c11 yearsThe number of patients with uncontrolled hemoglobin A1c (HbA1cc \> 9 any time, defined for 1-year prior to first IBTb visit, and 1-year after) in the diabetes and pre-diabetes cohorts.
Number of Patients With a COVID-19 Diagnosis and ICU Use, Ventilator Use, or Death1 yearIncidence of ICU admission, ventilator use, or death in patients with a COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.

Participant flow

Recruitment details

Participants' data was analyzed as part of a secondary data analysis analyzing de-identified EHR and Claims data. Participants did not consent to participate in this study.

Pre-assignment details

Participants were not randomized for this study.

Participants by arm

ArmCount
Diabetes
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019). Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes. Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
567
Pre-Diabetes
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height. Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
2
Total569

Baseline characteristics

CharacteristicDiabetesPre-DiabetesTotal
Age, Customized
Age
18-24 years
10,371 Participants259,691 Participants270062 Participants
Age, Customized
Age
25-34 years
23,169 Participants355,885 Participants379054 Participants
Age, Customized
Age
35-44 years
51,885 Participants340,065 Participants391950 Participants
Age, Customized
Age
45-54 years
105,646 Participants374,446 Participants480092 Participants
Age, Customized
Age
55-64 years
151,061 Participants346,075 Participants497136 Participants
Age, Customized
Age
65-74 years
131,104 Participants224,386 Participants355490 Participants
Age, Customized
Age
>75 years
94,672 Participants153,708 Participants248380 Participants
BMI32.9 kg/m^2
STANDARD_DEVIATION 7.9
30.9 kg/m^2
STANDARD_DEVIATION 6.2
31.55 kg/m^2
STANDARD_DEVIATION 7.14
Diastolic Blood Pressure75.0 mm Hg
STANDARD_DEVIATION 7.7
76.6 mm Hg
STANDARD_DEVIATION 7.4
75.24 mm Hg
STANDARD_DEVIATION 10.67
Ethnicity (NIH/OMB)
Hispanic or Latino
29,211 Participants105,438 Participants134649 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
514,125 Participants1,855,612 Participants2369737 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
24,572 Participants93,206 Participants117778 Participants
Hemoglobin A1c7.0 mg/dL5.6 mg/dL6.9 mg/dL
Race/Ethnicity, Customized
Race
American Indian or Alaska Native
1,860 Participants4,725 Participants6585 Participants
Race/Ethnicity, Customized
Race
Asian
10,809 Participants35,410 Participants46219 Participants
Race/Ethnicity, Customized
Race
Black
79,732 Participants216,860 Participants296592 Participants
Race/Ethnicity, Customized
Race
Multiple Race
397 Participants1,879 Participants2276 Participants
Race/Ethnicity, Customized
Race
Native Hawaiin or Other Pacific Islander
1,311 Participants4,413 Participants5724 Participants
Race/Ethnicity, Customized
Race
Other/Missing
34,851 Participants123,202 Participants158053 Participants
Race/Ethnicity, Customized
Race
White
438,948 Participants1,667,767 Participants2106715 Participants
Region of Enrollment
United States
Missing
66,297 Participants216,793 Participants283090 Participants
Region of Enrollment
United States
Rural
31,402 Participants92,934 Participants124336 Participants
Region of Enrollment
United States
Urban
470,209 Participants1,744,529 Participants2214738 Participants
Sex/Gender, Customized
Sex
Female
287,725 Participants1,167,327 Participants1455052 Participants
Sex/Gender, Customized
Sex
Male
280,170 Participants886,884 Participants1167054 Participants
Sex/Gender, Customized
Sex
Other/Missing
13 Participants45 Participants58 Participants
Systolic Blood Pressure130.4 mm Hg
STANDARD_DEVIATION 12.1
126.0 mm Hg
STANDARD_DEVIATION 11.9
127.03 mm Hg
STANDARD_DEVIATION 17.07

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

Change in Weight During Counseling Program

Weight change during counseling and/or % of weight change during program and maintained over remaining time period will be assessed in both the diabetes and pre-diabetes cohorts.

Time frame: 11 years

ArmMeasureValue (MEAN)Dispersion
DiabetesChange in Weight During Counseling Program206.8 lbsStandard Deviation 55
Pre-DiabetesChange in Weight During Counseling Program194.8 lbsStandard Deviation 44.9
Primary

Hemoglobin A1c

A1c of patients who received a telehealth visit and COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
DiabetesHemoglobin A1c6.6 mmol/molStandard Deviation 1.5
Pre-DiabetesHemoglobin A1c6.6 mmol/molStandard Deviation 1.5
Primary

Number of Participants Diagnosed With COVID-19 Who Were Hospitalized

Number of Participants Diagnosed with COVID-19 Who Were Hospitalized in both the diabetes and pre-diabetes cohorts.

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DiabetesNumber of Participants Diagnosed With COVID-19 Who Were Hospitalized1,025 Participants
Pre-DiabetesNumber of Participants Diagnosed With COVID-19 Who Were Hospitalized1,379 Participants
Primary

Number of Participants Who Used the Intensive Behavioral Therapy (IBT) Service

Number of patients who utilized IBT services was assessed in both the diabetes and pre-diabetes cohorts using code G0447.

Time frame: 11 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DiabetesNumber of Participants Who Used the Intensive Behavioral Therapy (IBT) Service2417 Participants
Pre-DiabetesNumber of Participants Who Used the Intensive Behavioral Therapy (IBT) Service3731 Participants
Secondary

Number of Patients Who Received Telehealth and Were Hospitalized With a COVID-19 Diagnosis

Number of patients who received telehealth and were hospitalized with a COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DiabetesNumber of Patients Who Received Telehealth and Were Hospitalized With a COVID-19 Diagnosis639 Participants
Pre-DiabetesNumber of Patients Who Received Telehealth and Were Hospitalized With a COVID-19 Diagnosis838 Participants
Secondary

Number of Patients With a COVID-19 Diagnosis and ICU Use, Ventilator Use, or Death

Incidence of ICU admission, ventilator use, or death in patients with a COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DiabetesNumber of Patients With a COVID-19 Diagnosis and ICU Use, Ventilator Use, or Death586 Participants
Pre-DiabetesNumber of Patients With a COVID-19 Diagnosis and ICU Use, Ventilator Use, or Death500 Participants
Secondary

Number of Patients With Uncontrolled Blood Pressure

The number of patients with uncontrolled blood pressure (SBP \> 140, DBP \> 90 all the time, defined for 1-year prior to first IBTb visit, and 1-year after) in the diabetes and pre-diabetes cohorts

Time frame: 11 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DiabetesNumber of Patients With Uncontrolled Blood Pressure300,665 Participants
Pre-DiabetesNumber of Patients With Uncontrolled Blood Pressure928,366 Participants
Secondary

Number of Patients With Uncontrolled Hemoglobin A1c

The number of patients with uncontrolled hemoglobin A1c (HbA1cc \> 9 any time, defined for 1-year prior to first IBTb visit, and 1-year after) in the diabetes and pre-diabetes cohorts.

Time frame: 11 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DiabetesNumber of Patients With Uncontrolled Hemoglobin A1c79,046 Participants
Pre-DiabetesNumber of Patients With Uncontrolled Hemoglobin A1c164 Participants

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026