Clinical trial NCT04335331: PreDM Clinical Decision Support Intervention
Official title: Prevent Diabetes Mellitus PreDM Clinical Decision Support Intervention in Community Health Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PreDiabetes
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: AllianceChicago
name: Erie Family Health Centers
First posted: 2020-04-06
Enrollment: 7424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A1c order
timeFrame: 18 Months
Secondary outcomes:
measure: Weight
timeFrame: 18 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Univeristy
state: Illinois
Study officials:
affiliation: Associate Professor
name: Matthew O'Brien, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: