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Clinical Trials/NCT05472142
NCT05472142
Completed
Not Applicable

Clinical Trial Protocol: Using Practice Facilitation and Operationalizing Referral Information Technology (UP FOR IT) to Increase DSMES Utilization

Mary Lacy1 site in 1 country22 target enrollmentMay 30, 2023
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Mary Lacy
Enrollment
22
Locations
1
Primary Endpoint
Diabetes Self-Management Education and Support (DSMES) Referrals
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

This is a pilot and feasibility study of a pragmatic cluster randomized trial that utilizes health information technology and practice facilitation to address referral barriers and increase clinician awareness and motivation to refer patients with diabetes to diabetes self-management education and services (DSMES).

Detailed Description

Diabetes self-management education and support (DSMES) is an evidence-based educational program that helps people with diabetes better control their blood sugar (improved hemoglobin A1c) and reduce diabetes-related complications and healthcare costs. DSMES is strikingly underutilized with fewer than 10% of eligible patients receiving this helpful service due to patient-, clinician-, and health system-level barriers that include low clinician awareness and lack of integrated referral processes between clinics and community-based DSMES programs. In this study, we will conduct a pilot and feasibility study of a pragmatic cluster randomized trial that utilizes health information technology and practice facilitation to address referral barriers and increase clinician awareness and motivation to refer patients with diabetes to DSMES. We have partnered with the Kentucky Department of Public Health (KDPH, statewide DSMES provider), the Kentucky Regional Extension Center (KY-REC, practice facilitation partner), and the Kentucky Health Information Exchange (health information technology (HIT) partner). We will recruit two healthcare systems in rural Kentucky to participate in the study. Within each healthcare organization, we will randomize control and intervention clusters at the clinic level. Clinics in the intervention group will participate in the 12-month intervention which incorporates health information technology and practice facilitation. The health information technology component provides the scaffolding for quality improvement efforts by automating patient identification and enabling bi-directional referral communication between providers and DSMES programs. Health information technology support will be available at all clinic sites within participating health care organizations, including the control clinics. The practice facilitation collaborative trains and supports clinical teams to use the Model for Improvement to make "breakthrough" improvements in diabetes care and DSMES utilization by recognizing barriers and changing clinical systems and care practices.

Registry
clinicaltrials.gov
Start Date
May 30, 2023
End Date
October 30, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mary Lacy
Responsible Party
Sponsor Investigator
Principal Investigator

Mary Lacy

Assistant Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • \- Clinics are being recruited to participate in the intervention. All clinic staff at participating clinics are eligible for inclusion in the study.

Exclusion Criteria

  • \- There are no exclusion criteria beyond employment at a participating clinic.

Outcomes

Primary Outcomes

Diabetes Self-Management Education and Support (DSMES) Referrals

Time Frame: Baseline, End of active intervention (month 9), End of follow-up (month 15)

DSMES referrals will be measured as the referral rate at baseline, the end of the active intervention and the end of the follow-up period. The outcome will be assessed through clinic electronic health record data.

Secondary Outcomes

  • Diabetes Self-Management Education and Support (DSMES) Attendance(Baseline, End of active intervention (month 9), End of follow-up (month 15))
  • Percent of Patients With A1c >9%(Baseline, End of active intervention (month 9), End of follow-up (month 15))

Study Sites (1)

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