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A Patient-Centered PaTH to Addressing Diabetes

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ClinicalTrials.gov Identifier: NCT02788903
Recruitment Status : Completed
First Posted : June 2, 2016
Results First Posted : October 1, 2021
Last Update Posted : October 1, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jennifer Kraschnewski, 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.

Condition or disease Intervention/treatment
Obesity Diabetes Covid19 Other: Weight Counseling

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.

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Study Type : Observational
Actual Enrollment : 2622164 participants
Observational Model: Cohort
Time Perspective: Other
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 Start Date : March 2016
Actual Primary Completion Date : May 2021
Actual Study Completion Date : May 2021


Group/Cohort Intervention/treatment
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).
Other: Weight Counseling
This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.

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




Primary Outcome Measures :
  1. Number of Participants Who Used the Intensive Behavioral Therapy (IBT) Service [ Time Frame: 11 years ]
    Number of patients who utilized IBT services was assessed in both the diabetes and pre-diabetes cohorts using code G0447.

  2. Change in Weight During Counseling Program [ Time Frame: 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.

  3. Hemoglobin A1c [ Time Frame: 1 year ]
    A1c of patients who received a telehealth visit and COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.

  4. Number of Participants Diagnosed With COVID-19 Who Were Hospitalized [ Time Frame: 1 year ]
    Number of Participants Diagnosed with COVID-19 Who Were Hospitalized in both the diabetes and pre-diabetes cohorts.


Secondary Outcome Measures :
  1. Number of Patients Who Received Telehealth and Were Hospitalized With a COVID-19 Diagnosis [ Time Frame: 1 year ]
    Number of patients who received telehealth and were hospitalized with a COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.

  2. Number of Patients With Uncontrolled Blood Pressure [ Time Frame: 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

  3. Number of Patients With Uncontrolled Hemoglobin A1c [ Time Frame: 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.

  4. Number of Patients With a COVID-19 Diagnosis and ICU Use, Ventilator Use, or Death [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788903


Sponsors and Collaborators
Milton S. Hershey Medical Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Jennifer L Kraschnewski, MD, MPH Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  Study Documents (Full-Text)

Documents provided by Jennifer Kraschnewski, Milton S. Hershey Medical Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Kraschnewski, Assistant Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02788903    
Other Study ID Numbers: PCORI
NEN-1509-32304 ( Other Grant/Funding Number: PCORI Contract Number )
First Posted: June 2, 2016    Key Record Dates
Results First Posted: October 1, 2021
Last Update Posted: October 1, 2021
Last Verified: September 2021
Keywords provided by Jennifer Kraschnewski, Milton S. Hershey Medical Center:
Obesity Counseling
telemedicine
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases