A Patient-Centered PaTH to Addressing Diabetes

Completed

Conditions: Covid19
Diabetes
Obesity

Interventions: Other: Weight Counseling

Registration Number: NCT02788903

Lead Sponsor: Milton S. Hershey Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2622164

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-Diabetes	Weight Counseling	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.
Diabetes	Weight Counseling	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).

Primary Outcome Measures

Name	Time	Method
Change in Weight During Counseling Program	11 years	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.
Hemoglobin A1c	1 year	A1c of patients who received a telehealth visit and COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.
Number of Participants Who Used the Intensive Behavioral Therapy (IBT) Service	11 years	Number of patients who utilized IBT services was assessed in both the diabetes and pre-diabetes cohorts using code G0447.
Number of Participants Diagnosed With COVID-19 Who Were Hospitalized	1 year	Number of Participants Diagnosed with COVID-19 Who Were Hospitalized in both the diabetes and pre-diabetes cohorts.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Uncontrolled Blood Pressure	11 years	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
Number of Patients Who Received Telehealth and Were Hospitalized With a COVID-19 Diagnosis	1 year	Number 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 Hemoglobin A1c	11 years	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.
Number of Patients With a COVID-19 Diagnosis and ICU Use, Ventilator Use, or Death	1 year	Incidence of ICU admission, ventilator use, or death in patients with a COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.