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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05472142
Other study ID # 75928
Secondary ID R34DK132548
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 30, 2023
Est. completion date July 2024

Study information

Verified date July 2023
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 22
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Kentukcy Lexington Kentucky

Sponsors (2)

Lead Sponsor Collaborator
Mary Lacy National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
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