Trial Outcomes & Findings for A Randomized Trial of a BE-EHR Module to Guide the Care of Older Adults With Diabetes (NCT NCT04181307)
NCT ID: NCT04181307
Last Updated: 2023-07-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7630 participants
Primary outcome timeframe
Month 18
Results posted on
2023-07-19
Participant Flow
Participant milestones
| Measure |
Standard EPIC Instantiation
As per standard procedure at NewYorkUniversity Langone Health
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
2986
|
4644
|
|
Overall Study
Assessed at Baseline
|
1342
|
2086
|
|
Overall Study
Assessed at 18 Months
|
1644
|
2558
|
|
Overall Study
COMPLETED
|
1342
|
2086
|
|
Overall Study
NOT COMPLETED
|
1644
|
2558
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Trial of a BE-EHR Module to Guide the Care of Older Adults With Diabetes
Baseline characteristics by cohort
| Measure |
Standard EPIC Instantiation
n=1342 Participants
As per standard procedure at NewYorkUniversity Langone Health
|
Standard EPIC Instantiation Plus the BE-EHR Module.
n=2086 Participants
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.
|
Total
n=3428 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81.8 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
81.4 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
81.6 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
776 Participants
n=5 Participants
|
1096 Participants
n=7 Participants
|
1872 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
566 Participants
n=5 Participants
|
990 Participants
n=7 Participants
|
1556 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
240 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
429 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
955 Participants
n=5 Participants
|
1624 Participants
n=7 Participants
|
2579 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
147 Participants
n=5 Participants
|
273 Participants
n=7 Participants
|
420 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
42 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
112 Participants
n=5 Participants
|
282 Participants
n=7 Participants
|
394 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
948 Participants
n=5 Participants
|
1501 Participants
n=7 Participants
|
2449 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
228 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
447 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1342 participants
n=5 Participants
|
2086 participants
n=7 Participants
|
3428 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 18In 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.
Outcome measures
| Measure |
Standard EPIC Instantiation
n=1644 Participants
As per standard procedure at NewYorkUniversity Langone Health
|
Standard EPIC Instantiation Plus the BE-EHR Module.
n=2558 Participants
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.
|
|---|---|---|
|
Number of Participants Who Are CW-Compliant and CW-Noncompliant
CW-Compliant
|
412 Participants
|
704 Participants
|
|
Number of Participants Who Are CW-Compliant and CW-Noncompliant
CW-Noncompliant
|
1232 Participants
|
1854 Participants
|
SECONDARY outcome
Timeframe: Month 18The 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
Outcome measures
| Measure |
Standard EPIC Instantiation
n=1644 Participants
As per standard procedure at NewYorkUniversity Langone Health
|
Standard EPIC Instantiation Plus the BE-EHR Module.
n=2558 Participants
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.
|
|---|---|---|
|
Number of Total Prescription Encounters
|
0 Prescription Encounters
|
2056 Prescription Encounters
|
Adverse Events
Standard EPIC Instantiation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths
Standard EPIC Instantiation Plus the BE-EHR Module.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 21 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place