Overview

This trial is active, not recruiting.

Conditions obesity, diabetes
Treatment weight counseling
Sponsor Milton S. Hershey Medical Center
Collaborator Patient-Centered Outcomes Research Institute
Start date March 2016
End date February 2021
Trial size 2000000 participants
Trial identifier NCT02788903, NEN-1509-32304, PCORI

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. We 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
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.
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.

Primary Outcomes

Measure
Weight loss
time frame: 10 years

Secondary Outcomes

Measure
Diabetes Incidence
time frame: 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 > 7.0%, 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) had at least 2 outpatient primary care visits in 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) had at least 2 outpatient primary care visits in one of the PaTH health systems in the past 3 years (since January 1, 2012), or (2) for whom claims data are available Exclusion Criteria: - Patients under the age of 18

Additional Information

Official title A Patient-Centered PaTH to Addressing Diabetes: Impact of State Health Policies on Diabetes Outcomes and Disparities
Principal investigator Jennifer L Kraschnewski, MD, MPH
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). We 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. We hypothesize that individual patients are more likely to receive counseling following coverage implementation. Further, we 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. We 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, we 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Milton S. Hershey Medical Center.