PreDM Clinical Decision Support Intervention (PreDM_CDS)

Prevent Diabetes Mellitus PreDM Clinical Decision Support Intervention in Community Health Centers

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes

Detailed Description

Eighty six million U.S. adults have prediabetes, and up to 75% of them will eventually develop diabetes. Landmark clinical trials have established that intensive lifestyle interventions (ILI) and metformin are safe and effective treatments to prevent or delay diabetes in adults with prediabetes and overweight/obesity. Despite being included in expert clinical guidelines, these treatments are rarely used and few studies have explored how to promote their uptake in practice. One possible approach for increasing adoption of ILI and metformin in primary care includes clinical decision support (CDS), which uses electronic systems to create tailored recommendations for evidence-based clinical care. While a large body of evidence demonstrates that CDS can improve the delivery of other recommended preventive services, this approach has not been definitively studied for ILI and metformin. The investigators plan to address this critical knowledge gap by developing and evaluating the Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention for community health center patients with prediabetes and overweight/obesity. This novel CDS engages primary care providers and clinical staff to deliver intervention components.

This study tests the potential for CDS to promote diabetes prevention and weight loss efforts in primary care. The current study objectives were to: 1) interview providers about their preferences for CDS focused on prediabetes; 2) develop a novel CDS tool, the Prediabetes CDS (PreDM CDS), promoting evidence-based care for prediabetes; and 3) conduct a pilot evaluation of the novel CDS tool using electronic health record data. Study investigators hypothesize that the proposed PreDM CDS will increase patient's adoption of ILI and metformin, producing modest weight loss and improvements in other cardiometabolic markers.

• Study Type: Observational
• Enrollment (Actual): 7424

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• The primary exclusion criterion is type 2 diabetes.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Mean between group differences in weight (lbs) evaluated using mixed models adjusted for clinic site, time between visits, sex, age, race/ethnicity, and baseline cardiometabolic markers.	18 Months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: AllianceChicago; Erie Family Health Centers
• Investigators: Principal Investigator: Matthew O'Brien, MD, MSc, Associate professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2020
• Primary Completion (ACTUAL): August 1, 2021
• Study Completion (ACTUAL): September 2, 2022

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (ACTUAL): April 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: STU00209789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No