N/A
Completed N=2,622,164
A Patient-Centered PaTH to Addressing Diabetes
Source: ClinicalTrials.gov NCT02788903 ↗Enrolled (actual)
2,622,164
Serious AEs
—
Results posted
Oct 2021
Primary outcomePrimary: Number of Participants Who Used the Intensive Behavioral Therapy (IBT) Service — 2417; 3731 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Used the Intensive Behavioral Therapy (IBT) Service |
2417; 3731 | — |
| PRIMARY Change in Weight During Counseling Program |
206.8; 194.8 | — |
| PRIMARY Hemoglobin A1c |
6.6; 6.6 | — |
| PRIMARY Number of Participants Diagnosed With COVID-19 Who Were Hospitalized |
1,025; 1,379 | — |
| SECONDARY Number of Patients Who Received Telehealth and Were Hospitalized With a COVID-19 Diagnosis |
639; 838 | — |
| SECONDARY Number of Patients With Uncontrolled Blood Pressure |
300,665; 928,366 | — |
| SECONDARY Number of Patients With Uncontrolled Hemoglobin A1c |
79,046; 164 | — |
| SECONDARY Number of Patients With a COVID-19 Diagnosis and ICU Use, Ventilator Use, or Death |
586; 500 | — |
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
Data sourced from ClinicalTrials.gov (NCT02788903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.