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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentukcy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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.
|
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.
|
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.
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 |
|---|---|---|
|
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.
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Baseline, End of active intervention (month 9), End of follow-up (month 15)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes Self-Management Education and Support (DSMES) Attendance
Time Frame: Baseline, End of active intervention (month 9), End of follow-up (month 15)
|
DSMES attendance will be measured as DSMES attendance rate at baseline, the end of the active intervention and the end of follow-up period.
The outcome will be assessed through aggregated, de-identified data that is routinely collected by DSMES providers.
|
Baseline, End of active intervention (month 9), End of follow-up (month 15)
|
|
Percent of Patients With A1c >9%
Time Frame: Baseline, End of active intervention (month 9), End of follow-up (month 15)
|
Percent of patients with A1c >9% at baseline, the end of the active intervention and the end of follow-up period.
The outcome will be assessed through clinic-level aggregate data extracted from electronic health record data.
|
Baseline, End of active intervention (month 9), End of follow-up (month 15)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mary Lacy, University of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 75928
- R34DK132548 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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