DiabetesNCT05472142
Using Practice Facilitation and Operationalizing Referral Information Technology to Increase DSMES Utilization
A study testing UP FOR IT - practice facilitation and UP FOR IT - health information technology in people with Diabetes, run by Mary Lacy at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- UP FOR IT - practice facilitation and UP FOR IT - health information technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2023to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinics are being recruited to participate in the intervention. All clinic staff at participating clinics are eligible for inclusion in the study.
Who cannot join
- There are no exclusion criteria beyond employment at a participating clinic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Diabetes
- Being tested
- UP FOR IT - practice facilitation, UP FOR IT - health information technology
- Keywords
- diabetes self-management education and support (DSMES), implementation science, practice facilitation, health information technology, evidence-based practice, rural clinics
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UP FOR IT - practice facilitationOther
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 technologyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: UP FOR IT - practice facilitation; Other: UP FOR IT - health information technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, End of active intervention (month 9), End of follow-up (month 15)
Secondary outcomes (2)
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.
Measured: Baseline, End of active intervention (month 9), End of follow-up (month 15)
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.
Measured: Baseline, End of active intervention (month 9), End of follow-up (month 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start30 May 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Lacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary Lacy, University of Kentucky
- Investigators
- Mary Lacy, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472142
- Sponsor's protocol ID
- 75928
- Other IDs
- R34DK132548
- Status last verified
- Nov 2025
- First submitted
- 21 Jul 2022
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41805383
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol: Using Practice Facilitation and Operationalizing Referral Information Technology (UP FOR IT) to Increase DSMES Utilization
- ClinicalTrials.gov ID
- NCT05472142
- Acronym / sponsor ID
- 75928
- Conditions
- Diabetes
- Keywords
- diabetes self-management education and support (DSMES), implementation science, practice facilitation, health information technology, evidence-based practice, rural clinics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mary LacyUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Posted 9 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Cluster | Active comparator | Other: UP FOR IT - health information technologyClinics 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. |
| Intervention Cluster | Experimental | Other: UP FOR IT - practice facilitation, Other: UP FOR IT - health information technologyClinics in the intervention group will participate in the 12-month intervention which incorporates health information technology and practice facilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinics are being recruited to participate in the intervention. All clinic staff at participating clinics are eligible for inclusion in the study.
Key exclusion criteria (1 listed)
- There are no exclusion criteria beyond employment at a participating clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UP FOR IT - practice facilitationUsing 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. | Other | Intervention Cluster |
| UP FOR IT - health information technologyUsing 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 | Control Cluster, Intervention Cluster |
Primary outcome
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.
2 secondary outcomes
Diabetes Self-Management Education and Support (DSMES) Attendance
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41805383Lacy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Lacy principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UP FOR IT - practice facilitation and UP FOR IT - health information technology in people with Diabetes, run by Mary Lacy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management Education and Support (DSMES) Referrals (time frame: Baseline, End of active intervention (month 9), End of follow-up (month 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05472142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.