Trial Outcomes & Findings for Using Practice Facilitation and Operationalizing Referral Information Technology to Increase DSMES Utilization (NCT NCT05472142)

Last Updated: 2025-12-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Baseline, End of active intervention (month 9), End of follow-up (month 15)

Results posted on

2025-12-09

Participant Flow

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).

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.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	Arm: Control Clinic Control clinic level	Arm: Intervention Clinic Intervention Clinic Level
Total Participants STARTED	726 2	1099 4
Total Participants COMPLETED	414 2	1099 4
Total Participants NOT COMPLETED	312 0	0 0
Clinic Patients STARTED	720 2	1083 4
Clinic Patients COMPLETED	408 2	1083 4
Clinic Patients NOT COMPLETED	312 0	0 0
Clinic Staff STARTED	6 2	16 4
Clinic Staff COMPLETED	6 2	16 4
Clinic Staff NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm: Control Clinic Control clinic level	Arm: Intervention Clinic Intervention Clinic Level
Total Participants Lost to Follow-up	312	0
Clinic Patients Lost to Follow-up	312	0

Baseline Characteristics

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.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline, End of active intervention (month 9), End of follow-up (month 15)

Population: 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.

Outcome measures

Outcome measures
Measure	Arm: Control Cluster n=720 Participants Active Comparator - number of participants	Arm: Intervention Cluster n=1083 Participants Experimental - number of participants
Diabetes Self-Management Education and Support (DSMES) Referrals Baseline	0 Participants	0 Participants
Diabetes Self-Management Education and Support (DSMES) Referrals End of active intervention	4 Participants	343 Participants
Diabetes Self-Management Education and Support (DSMES) Referrals End of follow-up	4 Participants	433 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm: Control Cluster n=720 Participants Active Comparator - number of participants	Arm: Intervention Cluster n=1083 Participants Experimental - number of participants
Diabetes Self-Management Education and Support (DSMES) Attendance End of active intervention	0 Participants	22 Participants
Diabetes Self-Management Education and Support (DSMES) Attendance End of follow-up	0 Participants	61 Participants
Diabetes Self-Management Education and Support (DSMES) Attendance Baseline	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm: Control Cluster n=720 Participants Active Comparator - number of participants	Arm: Intervention Cluster n=1083 Participants Experimental - number of participants
Percent of Patients With A1c >9% Baseline	149 Participants	206 Participants
Percent of Patients With A1c >9% End of active intervention	93 Participants	194 Participants
Percent of Patients With A1c >9% End of follow-up	93 Participants	173 Participants

Adverse Events

Arm: Control Cluster

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm: Intervention Cluster

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary E. Lacy, PhD, Study PI

University of Kentucky

Phone: 8595621126

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place