Using Practice Facilitation and Operationalizing Referral Information Technology to Increase DSMES Utilization

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes
• Intervention / Treatment: Other: UP FOR IT - health information technology; Other: UP FOR IT - practice facilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Elizabeth L Leigh, PhD; Phone Number: 8595621126; Email: mary.lacy@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentukcy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Cluster; Clinics in the control group will only be provided with health information technology; they will not participate in the 12-month intervention which incorporates health information technology and practice facilitation.	Other: UP FOR IT - health information technology; Using Practice Facilitation and Operationalizing Referral Information Technology (UP FOR IT) involves incorporation of 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 diabetes self-management education and services (DSMES) programs.
Experimental: Intervention Cluster; Clinics in the intervention group will participate in the 12-month intervention which incorporates health information technology and practice facilitation.	Other: UP FOR IT - health information technology; Using Practice Facilitation and Operationalizing Referral Information Technology (UP FOR IT) involves incorporation of 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 diabetes self-management education and services (DSMES) programs.; Other: UP FOR IT - practice facilitation; Using Practice Facilitation and Operationalizing Referral Information Technology (UP FOR IT) involves incorporation of health information technology and practice facilitation. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in DSMES Referrals	DSMES referrals will be measured as change in clinic-level referral rate from baseline to the end of the active intervention and follow-up period. The outcome will be assessed through clinic electronic health record data.	18 months (baseline and post-study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in DSMES Attendance	DSMES attendance will be measured as the change in clinic-level attendance rate from baseline to the end of the active intervention and follow-up period. The outcome will be assessed through aggregated, de-identified data that is routinely collected by DSMES providers.	18 months (baseline and post-study)
Change in A1c Levels	Participant A1c levels will be measured from baseline to the end of the active intervention and follow-up period. The outcome will be assessed through clinic-level aggregate data extracted from electronic health record data.	18 months (baseline and post-study)

Collaborators and Investigators

• Sponsor: Mary Lacy
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Mary Lacy, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: implementation science; health information technology; practice facilitation; evidence-based practice; diabetes self-management education and support (DSMES); rural clinics
• Other Study ID Numbers: 75928; R34DK132548 (U.S. NIH Grant/Contract)

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