Viewing Study NCT04922294



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Last Modification Date: 2024-10-26 @ 2:06 PM
Study NCT ID: NCT04922294
Status: COMPLETED
Last Update Posted: 2022-12-20
First Post: 2021-06-04

Brief Title: Implementation of a Cardiometabolic Disease Staging System in Primary Care
Sponsor: University of Alabama at Birmingham
Organization: University of Alabama at Birmingham

Study Overview

Official Title: Cardiometabolic Disease Staging System to Improve Medical Management of Obesity and Diabetes in Primary Care Settings
Status: COMPLETED
Status Verified Date: 2022-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None