Type Two Diabetes MellitusNCT07888179
Scaling up the DSMES Learning Collaborative
A study testing Multicomponent Implementation Strategy (MCIS) Bundle in people with Type Two Diabetes Mellitus, run by Mary Lacy at 1 site in United States.
Trial summary
A multicomponent implementation strategy bundle designed to improve Diabetes Self-Management Education and Support (DSMES) referral and utilization in rural primary care clinics. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Type Two Diabetes Mellitus
- What is being tested?
- Multicomponent Implementation Strategy (MCIS) Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2029to 31 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Members of implementation teams at participating rural primary care clinics, including physicians, nurses, hospital administrators, IT staff, and practice managers.
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kentucky
Lexington, Kentucky, 40506
Carol White, 859-562-2684, crwhit3@uky.edu
About this study
Official title: INSPIRED: Implementation of Novel Strategies to Promote Improvements in Referrals and Engagement for DSMES
A multicomponent implementation strategy bundle designed to improve Diabetes Self-Management Education and Support (DSMES) referral and utilization in rural primary care clinics. The initial bundle includes: (1) establishing electronic health record (EHR) referral systems, (2) creating patient face sheets for providers, (3) discussing DSMES referrals during clinician and staff implementation team meetings, and (4) developing DSMES-specific marketing materials and promotional activities.
Read the detailed description
This is a hybrid type 3 effectiveness-implementation trial involving primary care clinics among four healthcare systems in Kentucky. Cluster randomization of clinics (and the patients therein) will be stratified by healthcare system such that 2 clinics will be randomized to the intervention arm, and 2 clinics will be assigned to the control arm; across 4 health care systems, this will result in 8 clinics per study arm for a total of 16 clinics. Clinics randomized to intervention will implement an optimized multicomponent implementation strategy (MCIS) bundle (8 clinics) or standard of care (8 clinics) and implementation outcomes will be evaluated. The MCIS bundle is designed to improve Diabetes Self-Management Education and Support (DSMES) referral and utilization in rural primary care clinics in Kentucky and the initial bundle includes: (1) establishing electronic health record (EHR) referral systems, (2) creating patient face sheets for providers, (3) discussing DSMES referrals during clinician and staff implementation team meetings, and (4) developing DSMES-specific marketing materials and promotional activities. Primary implementation outcome is reach, as defined by proportion of eligible patients referred to DSMES. Secondary outcomes include provider-level adoption of learning collaborative activities, effectiveness (i.e., patient A1c, DSMES attendance), implementation (i.e., fidelity; perceived feasibility, acceptability, and appropriateness of implementation strategies; patient facilitators and barriers to DSMES attendance), and maintenance at 12-month follow-up. Following the trial, the cost-effectiveness of the optimized MCIS bundle will be determined.
- Conditions
- Type Two Diabetes Mellitus
- Being tested
- Multicomponent Implementation Strategy (MCIS) Bundle, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Implementation Strategy (MCIS) BundleBehavioural
A multicomponent implementation strategy designed to improve DSMES referral and utilization in rural primary care clinics. Strategies include establishing EHR referral systems, creating patient face sheets for providers, discussing DSMES referrals during clinician and staff implementation team meetings, and developing DSMES-specific marketing materials and promotional activities.
Standard of CareOther
Clinics randomized to standard-of-care group will continue their usual clinical practices without implementation of the multicomponent implementation strategy (MCIS) bundle.
| Study group | Role | What they receive |
|---|---|---|
| MCIS Bundle | Experimental | Rural primary care clinics randomized to the intervention group will receive the multicomponent implementation (MCIS) bundle designed to improve referral to and utilization of diabetes self-management education and support (DSMES). Receives: Behavioral: Multicomponent Implementation Strategy (MCIS) Bundle |
| Standard of Care | Active comparator | Rural primary care clinics randomized to the control group will continue standard of care without the implementation of the MCIS bundle. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible Patients Referred to DSMES
Percentage of eligible patients with diabetes who receive a referral to diabetes self-management education and support (DSMES).
Measured: 9 Months After Initiation of Intervention
Secondary outcomes (4)
Change in Mean HbA1c for Patients with HbA1c >9%
HbA1c control will be extracted from the electronic health record and assessed as change in mean HbA1c from baseline to the end of the intervention and at 1-month and 12-month follow-up, and change in the percentage of patients with HbA1c greater than 9%.
Measured: Baseline and monthly during active intervention through 12 month follow-up
Percentage of Providers Referring Patients to DSMES
Percentage of providers referring patients to DSMES, calculated as the number of providers referring patients to DSMES divided by the total number of providers at the clinic.
Measured: Baseline and monthly during active intervention through 12 month follow-up
Change in DSMES Referral Rate During the 12-Month Sustainment Period
Maintenance will be measured as the change in DSMES referral rate over the 12-month assessment period.
Measured: Monthly during the 12-month sustainment period
Percentage of Patients Completing DSMES
DSMES attendance will be extracted and reported by participating clinics. Attendance will be considered complete when a patient has attended 2 or more hours of DSMES, in alignment with state reporting.
Measured: Baseline and monthly during active intervention through 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Apr 2029 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type Two Diabetes MellitusStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mary Lacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary Lacy, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888179
- Sponsor's protocol ID
- 120049
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSPIRED: Implementation of Novel Strategies to Promote Improvements in Referrals and Engagement for DSMES
- ClinicalTrials.gov ID
- NCT07888179
- Acronym / sponsor ID
- 120049
- Conditions
- Type Two Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Mary LacyUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Apr 2029 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicomponent implementation strategy bundle designed to improve Diabetes Self-Management Education and Support (DSMES) referral and utilization in rural primary care clinics. The initial bundle includes: (1) establishing electronic health record (EHR) referral systems, (2) creating patient face sheets for providers, (3) discussing DSMES referrals during clinician and staff implementation team meetings, and (4) developing DSMES-specific marketing materials and promotional activities.
Detailed description
This is a hybrid type 3 effectiveness-implementation trial involving primary care clinics among four healthcare systems in Kentucky. Cluster randomization of clinics (and the patients therein) will be stratified by healthcare system such that 2 clinics will be randomized to the intervention arm, and 2 clinics will be assigned to the control arm; across 4 health care systems, this will result in 8 clinics per study arm for a total of 16 clinics. Clinics randomized to intervention will implement an optimized multicomponent implementation strategy (MCIS) bundle (8 clinics) or standard of care (8 clinics) and implementation outcomes will be evaluated. The MCIS bundle is designed to improve Diabetes Self-Management Education and Support (DSMES) referral and utilization in rural primary care clinics in Kentucky and the initial bundle includes: (1) establishing electronic health record (EHR) referral systems, (2) creating patient face sheets for providers, (3) discussing DSMES referrals during clinician and staff implementation team meetings, and (4) developing DSMES-specific marketing materials and promotional activities. Primary implementation outcome is reach, as defined by proportion of eligible patients referred to DSMES. Secondary outcomes include provider-level adoption of learning collaborative activities, effectiveness (i.e., patient A1c, DSMES attendance), implementation (i.e., fidelity; perceived feasibility, acceptability, and appropriateness of implementation strategies; patient facilitators and barriers to DSMES attendance), and maintenance at 12-month follow-up. Following the trial, the cost-effectiveness of the optimized MCIS bundle will be determined.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCIS Bundle | Experimental | Behavioral: Multicomponent Implementation Strategy (MCIS) BundleRural primary care clinics randomized to the intervention group will receive the multicomponent implementation (MCIS) bundle designed to improve referral to and utilization of diabetes self-management education and support (DSMES). |
| Standard of Care | Active comparator | Other: Standard of CareRural primary care clinics randomized to the control group will continue standard of care without the implementation of the MCIS bundle. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Members of implementation teams at participating rural primary care clinics, including physicians, nurses, hospital administrators, IT staff, and practice managers.
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| Multicomponent Implementation Strategy (MCIS) BundleA multicomponent implementation strategy designed to improve DSMES referral and utilization in rural primary care clinics. Strategies include establishing EHR referral systems, creating patient face sheets for providers, discussing DSMES referrals during clinician and staff implementation team meetings, and developing DSMES-specific marketing materials and promotional activities. | Behavioural | MCIS Bundle |
| Standard of CareClinics randomized to standard-of-care group will continue their usual clinical practices without implementation of the multicomponent implementation strategy (MCIS) bundle. | Other | Standard of Care |
Primary outcome
Percentage of Eligible Patients Referred to DSMES
Time frame: 9 Months After Initiation of Intervention
Percentage of eligible patients with diabetes who receive a referral to diabetes self-management education and support (DSMES).
4 secondary outcomes
Change in Mean HbA1c for Patients with HbA1c >9%
Time frame: Baseline and monthly during active intervention through 12 month follow-up
Percentage of Providers Referring Patients to DSMES
Time frame: Baseline and monthly during active intervention through 12 month follow-up
Change in DSMES Referral Rate During the 12-Month Sustainment Period
Time frame: Monthly during the 12-month sustainment period
Percentage of Patients Completing DSMES
Time frame: Baseline and monthly during active intervention through 12 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Implementation Strategy (MCIS) Bundle in people with Type Two Diabetes Mellitus, 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: opening soon, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol White (859-562-2684, crwhit3@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eligible Patients Referred to DSMES (time frame: 9 Months After Initiation of Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.