Diabetes
Conditions
Brief summary
This RCT will test a new electronic health record module to improve guideline-compliant care of older adults with diabetes. The module incorporates effective behavioral economics (BE) principles to improve the degree to which care of older adults is compliant with Choosing Wisely (CW) guidelines; this generally involves less aggressive targets for HbA1c, and reductions of medications other than metformin. The implementation of the module is triggered by patient scheduling and medication prescribing in EPIC. The BE principles include suggesting alternatives to medications, requiring justification, setting of appropriate default order sets, and incorporation of anchoring and checklists to guide behavior.
Interventions
BEHAVIORALBE-EHR module
The BE-EHR module includes six components: 1) a tailored advisory for patients over 75 with diabetes, 2) medication refill protocol with information on Choosing Wisely guidelines, 3) pre-population of the medication preference list with metformin, 4) lab result protocol with information on Choosing Wisely guidelines, 5) peer comparisons regarding performance meeting guidelines, and 6) media campaign with information about Choosing Wisely guidelines. The set of nudges is referred to collectively as the BE-EHR module.
Sponsors
National Institute on Aging (NIA)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient at NYULH primary care or endocrinology practice * Practices that have patients aged 75 or older * Practices that have a diagnosis of diabetes in the EHR chart
Exclusion criteria
• Under age 75
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Are CW-Compliant and CW-Noncompliant | Month 18 | In order to evaluate Choosing Wisely (CW) compliance status, the BE-EHR algorithm will capture information on demographics, diagnoses in the patient's problem list, prescription history, and relevant lab results (i.e. allergies and blood glucose (HbA1c)) The study team members will not collect this information directly; data will be collected in NYULH's EHR system, EPIC, and an EPIC Reporting analyst will extract the relevant parameters from the EHR into a report. The study team members only receive the ultimate determination from the algorithm that the patient is either CW-compliant or CW-noncompliant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Total Prescription Encounters | Month 18 | The Refill Protocol nudge activates in Epic any time a medication refill for either Metformin or a non-Metformin diabetes medication is generated for a patient over 75 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard EPIC Instantiation As per standard procedure at NewYorkUniversity Langone Health | 1,342 |
| Standard EPIC Instantiation Plus the BE-EHR Module. The BE-EHR module includes six components: 1) a tailored advisory for patients over 75 with diabetes, 2) medication refill protocol with information on Choosing Wisely guidelines, 3) pre-population of the medication preference list with metformin, 4) lab result protocol with information on Choosing Wisely guidelines, 5) peer comparisons regarding performance meeting guidelines, and 6) media campaign with information about Choosing Wisely guidelines. The set of nudges is referred to collectively as the BE-EHR module.
BE-EHR module: The BE-EHR module includes six components: 1) a tailored advisory for patients over 75 with diabetes, 2) medication refill protocol with information on Choosing Wisely guidelines, 3) pre-population of the medication preference list with metformin, 4) lab result protocol with information on Choosing Wisely guidelines, 5) peer comparisons regarding performance meeting guidelines, and 6) media campaign with information about Choosing Wisely guidelines. The set of nudges is referred to collectively as the BE-EHR module. | 2,086 |
| Total | 3,428 |
Baseline characteristics
| Characteristic | Standard EPIC Instantiation | Total | Standard EPIC Instantiation Plus the BE-EHR Module. |
|---|---|---|---|
| Age, Continuous | 81.8 years STANDARD_DEVIATION 4.5 | 81.6 years STANDARD_DEVIATION 4.5 | 81.4 years STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 240 Participants | 429 Participants | 189 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 955 Participants | 2579 Participants | 1624 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 147 Participants | 420 Participants | 273 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 42 Participants | 113 Participants | 71 Participants |
| Race (NIH/OMB) Black or African American | 112 Participants | 394 Participants | 282 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 228 Participants | 447 Participants | 219 Participants |
| Race (NIH/OMB) White | 948 Participants | 2449 Participants | 1501 Participants |
| Region of Enrollment United States | 1342 participants | 3428 participants | 2086 participants |
| Sex: Female, Male Female | 776 Participants | 1872 Participants | 1096 Participants |
| Sex: Female, Male Male | 566 Participants | 1556 Participants | 990 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 18 / 1,644 | 21 / 2,558 |
| other Total, other adverse events | 0 / 1,644 | 0 / 2,558 |
| serious Total, serious adverse events | 0 / 1,644 | 0 / 2,558 |
Outcome results
Primary
Number of Participants Who Are CW-Compliant and CW-Noncompliant
In order to evaluate Choosing Wisely (CW) compliance status, the BE-EHR algorithm will capture information on demographics, diagnoses in the patient's problem list, prescription history, and relevant lab results (i.e. allergies and blood glucose (HbA1c)) The study team members will not collect this information directly; data will be collected in NYULH's EHR system, EPIC, and an EPIC Reporting analyst will extract the relevant parameters from the EHR into a report. The study team members only receive the ultimate determination from the algorithm that the patient is either CW-compliant or CW-noncompliant.
Time frame: Month 18
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard EPIC Instantiation | Number of Participants Who Are CW-Compliant and CW-Noncompliant | CW-Compliant | 412 Participants |
| Standard EPIC Instantiation | Number of Participants Who Are CW-Compliant and CW-Noncompliant | CW-Noncompliant | 1232 Participants |
| Standard EPIC Instantiation Plus the BE-EHR Module. | Number of Participants Who Are CW-Compliant and CW-Noncompliant | CW-Compliant | 704 Participants |
| Standard EPIC Instantiation Plus the BE-EHR Module. | Number of Participants Who Are CW-Compliant and CW-Noncompliant | CW-Noncompliant | 1854 Participants |
Secondary
Number of Total Prescription Encounters
The Refill Protocol nudge activates in Epic any time a medication refill for either Metformin or a non-Metformin diabetes medication is generated for a patient over 75
Time frame: Month 18
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard EPIC Instantiation | Number of Total Prescription Encounters | 0 Prescription Encounters |
| Standard EPIC Instantiation Plus the BE-EHR Module. | Number of Total Prescription Encounters | 2056 Prescription Encounters |