NCT05472142

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 9, 2025

Completed
Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

July 21, 2022

Results QC Date

October 29, 2025

Last Update Submit

November 23, 2025

Conditions

Keywords

diabetes self-management education and support (DSMES)implementation sciencepractice facilitationhealth information technologyevidence-based practicerural clinics

Outcome Measures

Primary Outcomes (1)

  • Diabetes Self-Management Education and Support (DSMES) Referrals

    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.

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

Secondary Outcomes (2)

  • 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 Arms (2)

Control Cluster

ACTIVE COMPARATOR

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

Intervention Cluster

EXPERIMENTAL

Clinics in the intervention group will participate in the 12-month intervention which incorporates health information technology and practice facilitation.

Other: UP FOR IT - practice facilitationOther: UP FOR IT - health information technology

Interventions

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.

Intervention Cluster

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.

Control ClusterIntervention Cluster

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentukcy

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

  • Lacy ME, Elliott J, Drakeford V, Wright L, McKune B, Douthitt KC, Kruse-Diehr AJ, Keck JW. Increasing Uptake of Diabetes Self-Management Education and Support (DSMES) in Rural Kentucky Primary Care Clinics: Findings From a Pilot Pragmatic Cluster-Randomized Trial. J Prim Care Community Health. 2026 Jan-Dec;17:21501319261428883. doi: 10.1177/21501319261428883. Epub 2026 Mar 10.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Mary E. Lacy, PhD, Study PI
Organization
University of Kentucky

Study Officials

  • Mary Lacy

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

May 30, 2023

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

December 9, 2025

Results First Posted

December 9, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations