Clinical trial NCT02788903: A Patient-Centered PaTH to Addressing Diabetes
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Diabetes
Covid19
Keywords: Obesity Counseling
telemedicine
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-06-02
Enrollment: 2622164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Data will be collected through the PaTH Clinical Data Research Network (CDRN), a partnership of six academic health systems (Penn State Hershey Medical Center, University of Pittsburgh Medical Center, Temple Health System, Johns Hopkins Health System, University of Utah and Geisinger Health System) creating an electronic health record (EHR)-based data infrastructure across three states (Maryland, Pennsylvania, and Utah).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Used the Intensive Behavioral Therapy (IBT) Service
timeFrame: 11 years
measure: Change in Weight During Counseling Program
timeFrame: 11 years
measure: Hemoglobin A1c
timeFrame: 1 year
measure: Number of Participants Diagnosed With COVID-19 Who Were Hospitalized
timeFrame: 1 year
Secondary outcomes:
measure: Number of Patients Who Received Telehealth and Were Hospitalized With a COVID-19 Diagnosis
timeFrame: 1 year
measure: Number of Patients With Uncontrolled Blood Pressure
timeFrame: 11 years
measure: Number of Patients With Uncontrolled Hemoglobin A1c
timeFrame: 11 years
measure: Number of Patients With a COVID-19 Diagnosis and ICU Use, Ventilator Use, or Death
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
name: Jennifer L Kraschnewski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeh HC, Kraschnewski JL, Kong L, Lehman EB, Heilbrunn ES, Williams P, Poger JM, Francis E, Bryce CL. Hospitalization and mortality in patients with COVID-19 with or at risk of type 2 diabetes: data from five health systems in Pennsylvania and Maryland. BMJ Open Diabetes Res Care. 2022 Jun;10(3):e002774. doi: 10.1136/bmjdrc-2022-002774.