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Implementation of a Cardiometabolic Disease Staging System in Primary Care

NCT ID: NCT04922294

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-20

Study Completion Date

2022-12-05

Brief Summary

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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

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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.

Conditions

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Diabetes Obesity Overweight

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Clinical decision support system

To develop a clinical decision support system based on a published cardiometabolic disease staging system.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Physicians ≥19
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Tapan Shirish Mehta

Associate Professor, Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tapan S Mehta, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-300003559

Identifier Type: -

Identifier Source: org_study_id