Diabetes
Conditions
Keywords
diabetes self-management education and support (DSMES), implementation science, practice facilitation, health information technology, evidence-based practice, rural clinics
Brief 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).
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.
Interventions
OTHERUP FOR IT - practice facilitation
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.
OTHERUP FOR IT - health information technology
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mary Lacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Self-Management Education and Support (DSMES) Referrals | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Self-Management Education and Support (DSMES) Attendance | 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. |
| Percent of Patients With A1c >9% | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm: Control Cluster Active Comparator - number of participants | 726 |
| Arm: Intervention Cluster Experimental - number of participants | 1,099 |
| Total | 1,825 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Clinic Patients | Lost to Follow-up | 312 | 0 |
| Total Participants | Lost to Follow-up | 312 | 0 |
Baseline characteristics
| Characteristic | Total | Arm: Intervention Cluster | Arm: Control Cluster |
|---|---|---|---|
| Age, Customized Clinic staff 18-75 years old | 22 Participants | 16 Participants | 6 Participants |
| Age, Customized Clinic staff <18 years old | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Clinic staff >75 years old | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Patients 18-75 years old | 1803 Participants | 1083 Participants | 720 Participants |
| Age, Customized Patients <18 years old | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Patients >75 years old | 0 Participants | 0 Participants | 0 Participants |
| Diabetes Self-Management Education & Support referral during 12-month baseline period Not referred to DSMES | 1803 Participants | 1083 Participants | 720 Participants |
| Diabetes Self-Management Education & Support referral during 12-month baseline period Referred to DSMES | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Clinic Staff Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Clinic Staff Not Hispanic or Latino | 22 Participants | 16 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Clinic Staff Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Patients Hispanic or Latino | 6 Participants | 6 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Patients Not Hispanic or Latino | 1785 Participants | 1065 Participants | 720 Participants |
| Ethnicity (NIH/OMB) Patients Unknown or Not Reported | 12 Participants | 12 Participants | 0 Participants |
| Percent of patient population with A1c >9% at baseline A1c greater than 9% | 355 Participants | 206 Participants | 149 Participants |
| Percent of patient population with A1c >9% at baseline A1c less than or equal to 9% | 1448 Participants | 877 Participants | 571 Participants |
| Race (NIH/OMB) Clinic Staff American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Clinic Staff Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Clinic Staff Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Clinic Staff More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Clinic Staff Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Clinic Staff Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Clinic Staff White | 22 Participants | 16 Participants | 6 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Patients Black or African American | 7 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) Patients More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 28 Participants | 12 Participants | 16 Participants |
| Race (NIH/OMB) Patients White | 1766 Participants | 1064 Participants | 702 Participants |
| Region of Enrollment United States | 1825 Participants | 1099 Participants | 726 Participants |
| Sex: Female, Male Clinic Staff Female | 21 Participants | 15 Participants | 6 Participants |
| Sex: Female, Male Clinic Staff Male | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Patients Female | 1700 Participants | 1000 Participants | 700 Participants |
| Sex: Female, Male Patients Male | 103 Participants | 83 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm: Control Cluster | Diabetes Self-Management Education and Support (DSMES) Referrals | End of follow-up | 4 Participants |
| Arm: Control Cluster | Diabetes Self-Management Education and Support (DSMES) Referrals | Baseline | 0 Participants |
| Arm: Control Cluster | Diabetes Self-Management Education and Support (DSMES) Referrals | End of active intervention | 4 Participants |
| Arm: Intervention Cluster | Diabetes Self-Management Education and Support (DSMES) Referrals | End of follow-up | 433 Participants |
| Arm: Intervention Cluster | Diabetes Self-Management Education and Support (DSMES) Referrals | Baseline | 0 Participants |
| Arm: Intervention Cluster | Diabetes Self-Management Education and Support (DSMES) Referrals | End of active intervention | 343 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm: Control Cluster | Diabetes Self-Management Education and Support (DSMES) Attendance | Baseline | 0 Participants |
| Arm: Control Cluster | Diabetes Self-Management Education and Support (DSMES) Attendance | End of active intervention | 0 Participants |
| Arm: Control Cluster | Diabetes Self-Management Education and Support (DSMES) Attendance | End of follow-up | 0 Participants |
| Arm: Intervention Cluster | Diabetes Self-Management Education and Support (DSMES) Attendance | Baseline | 0 Participants |
| Arm: Intervention Cluster | Diabetes Self-Management Education and Support (DSMES) Attendance | End of active intervention | 22 Participants |
| Arm: Intervention Cluster | Diabetes Self-Management Education and Support (DSMES) Attendance | End of follow-up | 61 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm: Control Cluster | Percent of Patients With A1c >9% | Baseline | 149 Participants |
| Arm: Control Cluster | Percent of Patients With A1c >9% | End of active intervention | 93 Participants |
| Arm: Control Cluster | Percent of Patients With A1c >9% | End of follow-up | 93 Participants |
| Arm: Intervention Cluster | Percent of Patients With A1c >9% | Baseline | 206 Participants |
| Arm: Intervention Cluster | Percent of Patients With A1c >9% | End of active intervention | 194 Participants |
| Arm: Intervention Cluster | Percent of Patients With A1c >9% | End of follow-up | 173 Participants |