Implementation of a Cardiometabolic Disease Staging System in Primary Care

Obesity Clinical Trial

Official title:

Cardiometabolic Disease Staging System to Improve Medical Management of Obesity and Diabetes in Primary Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04922294
• Other study ID #: IRB-300003559
• Status: Completed
• Start date: July 20, 2020
• Est. completion date: December 5, 2022

Study information

• Verified date: December 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to develop a clinical decision support system (CDSS) that incorporates obesity management guidelines and treatment options for use by physicians and, potentially, patients based on a cardiometabolic disease staging system. This CDSS will be designed using primary care provider input through a qualitative approach to explore physician preferences for the appearance, electronic location, treatment options, referrals, accessibility and other user requirements of the CDSS.

Description:

To provide appropriate medical management of obesity and facilitate the diabetes risk assessments of people with excess adiposity, a comprehensive staging system that establishes five stages of cardiometabolic disease risk-the cardiometabolic disease staging system (CMDS) has been developed. This staging is based on Adult Treatment Panel III metabolic syndrome risk factors to guide decision making for selection of treatment modality and intensity in the management of obesity. Hence, the study hypothesis is that providing CMDS to PCPs through a CDSS for medical management of obesity can aid in reducing the barriers of obesity and diabetes treatment at the PCP-level and improve the quality of obesity and diabetes care. In this pilot and feasibility study, investigators will implement an early-phase CDSS in a pragmatic PCP setting to assess the uptake and acceptability of CDSS delivered to PCPs implementing CMDS at the point of care, and collect pilot data to assess change in patient engagement and satisfaction.

Investigators will conduct initial focus groups with PCPs and a series of iterative design steps targeting PCP and patient needs. These qualitative interviews would be used to determine the initial set of requirements and prototypes of the user interfaces and notifications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 5, 2022
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Primary care physicians employed at the University of Alabama at Birmingham

Exclusion Criteria:

• Physicians =19

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Overweight

Intervention

Other:
• Clinical decision support system
To develop a clinical decision support system based on a published cardiometabolic disease staging system.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation preferences	Preferences for implementation and development of a cardiometabolic disease staging system for a clinical decision support system as identified by clinicians during qualitative focus groups	Over one hour interviews or focus groups