PreDM Clinical Decision Support Intervention

NCT04335331 | Completed DMC

• 1 other identifier: STU00209789
• Study Type: observational
• Target: 7,424
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical practice guidelines recommend intensive lifestyle interventions and metformin to prevent or delay type 2 diabetes; yet these treatments are not routinely used among the 86 million U.S. adults with prediabetes who may benefit from them. While clinical decision support (CDS) represents an effective approach for delivering guideline-based care, the potential of this strategy to improve diabetes prevention efforts has not been definitively tested. This study developed the novel Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention and evaluated its impact on clinical outcomes.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• A1c order

  Mean differences in rates of hemoglobin A1c orders between treatment arms evaluated using mixed models adjusted for clinic site, time between visits, sex, age, race/ethnicity, and baseline cardiometabolic markers.

  18 Months

Secondary Outcomes (1)

• Weight

  18 Months

Study Arms (1)

PreDM CDS

The PreDM CDS is a passive electronic health record button that appears automatically under the Assessment/ Plan only for patients with prediabetes. When clinicians choose to click on this button, the PreDM CDS displays the last three measurements of weight, body mass index (BMI), hemoglobin A1c (HbA1c), fasting glucose, random glucose, and creatinine. This tool included order options enabling prediabetes management in a single location within the electronic health record.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who receive primary care at participating clinics and who meet the study eligibility criteria based on automated searches of the electronic health record systems will be eligible to participate.

You may qualify if:

• age ≥18 years old
• prediabetes
• two weight measurements during the study period

You may not qualify if:

• The following additional criteria will exclude those in whom treatment is potentially harmful or outcomes assessment may be confounded: serum creatinine \>1.4mg/dL in women and \>1.5mg/dL in men, uncontrolled hypertension (≥180/100mmHg), prior antidiabetic medication orders, and gastric bypass surgery or pregnancy during the evaluation period.

Sponsors & Collaborators

• Northwestern University: lead
• AllianceChicago: collaborator
• Erie Family Health Centers: collaborator

Study Sites (1)

Northwestern Univeristy

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Matthew O'Brien, MD, MSc

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 6, 2020
• Study Start: February 27, 2020
• Primary Completion: August 1, 2021
• Study Completion: September 2, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)