A Patient-Centered PaTH to Addressing Diabetes

Obesity Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788903
• Other study ID #: PCORI
• Secondary ID: NEN-1509-32304
• Status: Completed
• Start date: March 2016
• Est. completion date: May 2021

Study information

• Verified date: May 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2622164
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Diabetes
• Diabetes Mellitus
• Obesity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Patient-Centered Outcomes Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	11 years
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.	11 years
Primary	Hemoglobin A1c	A1c of patients who received a telehealth visit and COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.	1 year
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.	1 year
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.	1 year
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	11 years
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.	11 years
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.	1 year