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| ID | Type | Description | Link |
|---|---|---|---|
| R34DK132548 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Intervention Cluster | Experimental | Clinics in the intervention group will participate in the 12-month intervention which incorporates health information technology and practice facilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UP FOR IT - practice facilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Self-Management Education and Support (DSMES) Attendance | 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) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Mary Lacy | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentukcy | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41805383 | Derived | 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. |
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Study participants included clinic staff (n=22 total, consented) and patients (n=1,803, not consented). Clinic staff received the intervention and patients of clinics could be indirectly impacted by intervention. Clinic staff aggregated patient data up to the clinic-level prior to sharing with the study team. Patients were not consented as there was no interaction from members of the research team with patients and there was no use of identifiable private information for research purposes.
We partnered with two healthcare systems in rural Kentucky to test a pragmatic cluster-randomized trial. Within each healthcare system, we identified three primary care clinics that had a sufficient volume (N>50) of patients age 18-75 with diabetes. We randomized two of the clinics within each healthcare system to the intervention arm (total intervention clinics = 4) and one to the control arm (total control clinics =2).
| ID | Title | Description |
|---|---|---|
| FG000 | Arm: Control Clinic | Control clinic level |
| FG001 | Arm: Intervention Clinic | Intervention Clinic Level |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total Participants |
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| Clinic Patients |
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| Clinic Staff |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm: Control Cluster | Active Comparator - number of participants |
| BG001 | Arm: Intervention Cluster | Experimental - number of participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The Row populations differs from the Overall population because there are two distinct populations that, together, make up the Overall population - clinic staff and patients. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Measure Analysis Population Description: The analysis population differs from the Overall population because the study has two distinct populations that, together, make up the Overall population - clinic staff and patients. This study-specific baseline measure was only captured on one of the two populations - patients. | Posted | Count of Participants | Participants | Baseline, End of active intervention (month 9), End of follow-up (month 15) |
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Adverse events were not monitored/assessed for clinic staff or patients
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm: Control Cluster | Active Comparator - number of participants | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary E. Lacy, PhD, Study PI | University of Kentucky | 8595621126 | mary.lacy@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2024 | Oct 28, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2024 | Nov 19, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| UP FOR IT - health information technology | Other | 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. |
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| Percent of Patients With A1c >9% | 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) |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | The Row populations differs from the Overall population because there are two distinct populations that, together, make up the Overall population - clinic staff and patients. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | The Row populations differs from the Overall population because there are two distinct populations that, together, make up the Overall population - clinic staff and patients. | Count of Participants | Participants |
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| Race (NIH/OMB) | The Row populations differs from the Overall population because there are two distinct populations that, together, make up the Overall population - clinic staff and patients. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Diabetes Self-Management Education & Support referral during 12-month baseline period | The analysis population differs from the Overall population because the study has two distinct populations that, together, make up the Overall population - clinic staff and patients. This study-specific baseline measure was only captured on one of the two populations - patients. | Count of Participants | Participants |
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| Percent of patient population with A1c >9% at baseline | Measure Analysis Population Description: The analysis population differs from the Overall population because the study has two distinct populations that, together, make up the Overall population - clinic staff and patients. This study-specific baseline measure was only captured on one of the two populations - patients. | Count of Participants | Participants |
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| OG001 |
| Arm: Intervention Cluster |
Experimental - number of participants |
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| Secondary | Diabetes Self-Management Education and Support (DSMES) Attendance | 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. | Measure Analysis Population Description: The analysis population differs from the Overall population because the study has two distinct populations that, together, make up the Overall population - clinic staff and patients. This study-specific baseline measure was only captured on one of the two populations - patients. | Posted | Count of Participants | Participants | Baseline, End of active intervention (month 9), End of follow-up (month 15) |
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| Secondary | Percent of Patients With A1c >9% | 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. | Measure Analysis Population Description: The analysis population differs from the Overall population because the study has two distinct populations that, together, make up the Overall population - clinic staff and patients. This study-specific baseline measure was only captured on one of the two populations - patients. | Posted | Count of Participants | Participants | Baseline, End of active intervention (month 9), End of follow-up (month 15) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Arm: Intervention Cluster | Experimental - number of participants | 0 | 0 | 0 | 0 | 0 | 0 |
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| 18-75 years old |
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| >75 years old |
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| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| End of follow-up |
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| End of active intervention |
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| End of follow-up |
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