Trial Outcomes & Findings for Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial (NCT NCT04289753)
NCT ID: NCT04289753
Last Updated: 2023-08-16
Results Overview
Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
COMPLETED
NA
37134 participants
18 months
2023-08-16
Participant Flow
Unit of analysis: Clinic
Participant milestones
| Measure |
Brief Clinician Education
Clinicians attributed to clinics in the brief clinician education arm will receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
Brief clinician education: Clinicians will be invited to view brief education material.
|
Clinical Decision Support Nudges and Brief Clinician Education
Clinicians attributed to clinics randomized to the clinical decision support nudges and brief clinician decision support arm will receive clinical decision support within the EHR when conditions meet alert triggering criteria. These clinicians will also receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
EHR clinical decision support nudges: Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
Brief clinician education: Clinicians will be invited to view brief education material.
|
|---|---|---|
|
Overall Study
STARTED
|
18709 30
|
18425 30
|
|
Overall Study
COMPLETED
|
18709 30
|
18425 30
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial
Baseline characteristics by cohort
| Measure |
Brief Clinician Education
n=18709 Participants
Clinicians attributed to clinics in the brief clinician education arm will receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
Brief clinician education: Clinicians will be invited to view brief education material.
|
Clinical Decision Support Nudges and Brief Clinician Education
n=18425 Participants
Clinicians attributed to clinics randomized to the clinical decision support nudges and brief clinician decision support arm will receive clinical decision support within the EHR when conditions meet alert triggering criteria. These clinicians will also receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
EHR clinical decision support nudges: Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
Brief clinician education: Clinicians will be invited to view brief education material.
|
Total
n=37134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.0 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
77.7 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
77.8 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11244 Participants
n=5 Participants
|
11435 Participants
n=7 Participants
|
22679 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7465 Participants
n=5 Participants
|
6990 Participants
n=7 Participants
|
14455 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
699 Participants
n=5 Participants
|
974 Participants
n=7 Participants
|
1673 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
15209 Participants
n=5 Participants
|
14721 Participants
n=7 Participants
|
29930 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1227 Participants
n=5 Participants
|
1338 Participants
n=7 Participants
|
2565 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1574 Participants
n=5 Participants
|
1392 Participants
n=7 Participants
|
2966 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18709 participants
n=5 Participants
|
18425 participants
n=7 Participants
|
37134 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsMeasure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
Outcome measures
| Measure |
Brief Clinician Education
n=5169 Participants
Clinicians attributed to clinics in the brief clinician education arm will receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
Brief clinician education: Clinicians will be invited to view brief education material.
|
Clinical Decision Support Nudges and Brief Clinician Education
n=4811 Participants
Clinicians attributed to clinics randomized to the clinical decision support nudges and brief clinician decision support arm will receive clinical decision support within the EHR when conditions meet alert triggering criteria. These clinicians will also receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
EHR clinical decision support nudges: Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
Brief clinician education: Clinicians will be invited to view brief education material.
|
|---|---|---|
|
PSA Screening in Older Men
|
1675 Participants
|
1373 Participants
|
PRIMARY outcome
Timeframe: 18 monthsMeasure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period.
Outcome measures
| Measure |
Brief Clinician Education
n=4535 Participants
Clinicians attributed to clinics in the brief clinician education arm will receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
Brief clinician education: Clinicians will be invited to view brief education material.
|
Clinical Decision Support Nudges and Brief Clinician Education
n=4264 Participants
Clinicians attributed to clinics randomized to the clinical decision support nudges and brief clinician decision support arm will receive clinical decision support within the EHR when conditions meet alert triggering criteria. These clinicians will also receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
EHR clinical decision support nudges: Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
Brief clinician education: Clinicians will be invited to view brief education material.
|
|---|---|---|
|
Urine Testing for Non-specific Reasons
|
1127 Participants
|
1032 Participants
|
PRIMARY outcome
Timeframe: 18 monthsMeasure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus.
Outcome measures
| Measure |
Brief Clinician Education
n=3781 Participants
Clinicians attributed to clinics in the brief clinician education arm will receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
Brief clinician education: Clinicians will be invited to view brief education material.
|
Clinical Decision Support Nudges and Brief Clinician Education
n=3624 Participants
Clinicians attributed to clinics randomized to the clinical decision support nudges and brief clinician decision support arm will receive clinical decision support within the EHR when conditions meet alert triggering criteria. These clinicians will also receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
EHR clinical decision support nudges: Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
Brief clinician education: Clinicians will be invited to view brief education material.
|
|---|---|---|
|
Diabetes Overtreatment in the Elderly
|
603 Participants
|
605 Participants
|
SECONDARY outcome
Timeframe: 18 monthsEmergency department visit or hospitalization for an infection originating from the urinary tract within 28 days of any primary care office visit with decision support exposure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsEmergency department visit or hospitalization for an infection originating from the urinary tract within 28 days of any primary care office visit
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsEmergency department visit or hospitalization for hyperglycemia within 90 days of an index visit where the clinician was exposed to the diabetes decision support.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsEmergency department visit or hospitalization for hyperglycemia among patients who previously had a HbA1c \<7.0 and met the criteria for treatment deintensification intervention and had one or more outpatient primary care encounters during the study period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsOccurrence of HbA1c \>9.0 among patients who previously had a HbA1c \<7.0 and met the criteria for treatment deintensification intervention and had one or more outpatient primary care encounters during the study period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsEmergency department visit or hospitalization for hypoglycemia among patients who previously had a HbA1c \<7.0 and met the criteria for treatment deintensification intervention and had one or more outpatient primary care encounters during the study period
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 19-30 monthsMeasure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 19-30 monthsMeasure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 19-30 monthsMeasure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 months and 19-30 monthsRate of prostate biopsy among men \>=76 with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer at the beginning of the measurement period
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 months and 19-30 monthsRate of prostate MRI among men \>=76 with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer at the beginning of the measurement period
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 months and 19-30 monthsRate of prostate cancer diagnosis among men \>=76 with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer at the beginning of the measurement period
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 months and 19-30 monthsPresence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period ordered by a non-primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 months and 19-30 monthsMeasure defined as the presence of a PSA laboratory result in the EHR during the measurement period for men aged 55-69 and men aged 70-75 who are without a diagnosis suggesting a history of prostate cancer
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 months and 19-30 monthsProportion of all women with one or more visit to an eligible clinic during the prior 12 months receiving urinalysis and/or urine culture
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 months and 19-30 monthsProportion of all women with one or more encounter to an eligible clinic during the prior 12 months receiving an antibiotic for confirmed or possible UTI.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 months, 24 monthsProportion of patients 75 years old and older with initial HbA1c \<7.0 and treated with insulin, sulfonylurea or meglitinides who have a dose reduction
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsNIH-required analysis. Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsNIH-required analysis. Measure defined as the presence of a PSA laboratory result in the EHR during the measurement period among men aged 76 years and older at the start of the measurement period with at least one visit during the measurement period with a primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsNIH-required analysis. Measure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsNIH-required analysis. Measure defined as the absence of a diagnostic code for a specific genitourinary sign, symptoms or other potentially relevant indication among instances where a urinalysis and/or urine culture is obtained in the interval 24 hours before to 48 hours after a face-to-face ambulatory care visit by a woman aged 65 years or older with a primary care clinician during the measurement period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsNIH-required analysis. Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsNIH-required analysis. Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsNIH-required analysis. Measure defined as having the most recent hemoglobin A1C during the measurement period of less than 7.0 and insulin or an oral hypoglycemic drug on their active medication list at the end of the measurement period among adults aged 75 years and older with a diagnosis of diabetes mellitus.
Outcome measures
Outcome data not reported
Adverse Events
Brief Clinician Education
Clinical Decision Support Nudges and Brief Clinician Education
Serious adverse events
| Measure |
Brief Clinician Education
n=668 participants at risk；n=38607 participants at risk
Clinicians attributed to clinics in the brief clinician education arm will receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
Brief clinician education: Clinicians will be invited to view brief education material.
|
Clinical Decision Support Nudges and Brief Clinician Education
n=782 participants at risk；n=35786 participants at risk
Clinicians attributed to clinics randomized to the clinical decision support nudges and brief clinician decision support arm will receive clinical decision support within the EHR when conditions meet alert triggering criteria. These clinicians will also receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
EHR clinical decision support nudges: Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
Brief clinician education: Clinicians will be invited to view brief education material.
|
|---|---|---|
|
Renal and urinary disorders
EHR-identified ED or hospital care possibly due to UTI or sepsis
|
2.5%
977/38607 • These adverse event data were collected over 18-month trial intervention period.
All adverse event outcomes were systematically queried for using electronic health record data. Each adverse event is for a specific, separate clinical outcome. The denominators of patients 'at risk' differ by adverse event. For example, male patients who were included in denominator for diabetes outcomes are not 'at risk' for interventions or outcome denominators aimed at urine studies for female patients.
|
3.0%
1090/35786 • These adverse event data were collected over 18-month trial intervention period.
All adverse event outcomes were systematically queried for using electronic health record data. Each adverse event is for a specific, separate clinical outcome. The denominators of patients 'at risk' differ by adverse event. For example, male patients who were included in denominator for diabetes outcomes are not 'at risk' for interventions or outcome denominators aimed at urine studies for female patients.
|
|
General disorders
EHR-Identified ED or hospital care possibly due to hyperglycemia
|
0.05%
19/38607 • These adverse event data were collected over 18-month trial intervention period.
All adverse event outcomes were systematically queried for using electronic health record data. Each adverse event is for a specific, separate clinical outcome. The denominators of patients 'at risk' differ by adverse event. For example, male patients who were included in denominator for diabetes outcomes are not 'at risk' for interventions or outcome denominators aimed at urine studies for female patients.
|
0.03%
10/35786 • These adverse event data were collected over 18-month trial intervention period.
All adverse event outcomes were systematically queried for using electronic health record data. Each adverse event is for a specific, separate clinical outcome. The denominators of patients 'at risk' differ by adverse event. For example, male patients who were included in denominator for diabetes outcomes are not 'at risk' for interventions or outcome denominators aimed at urine studies for female patients.
|
Other adverse events
| Measure |
Brief Clinician Education
n=668 participants at risk；n=38607 participants at risk
Clinicians attributed to clinics in the brief clinician education arm will receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
Brief clinician education: Clinicians will be invited to view brief education material.
|
Clinical Decision Support Nudges and Brief Clinician Education
n=782 participants at risk；n=35786 participants at risk
Clinicians attributed to clinics randomized to the clinical decision support nudges and brief clinician decision support arm will receive clinical decision support within the EHR when conditions meet alert triggering criteria. These clinicians will also receive invitation to view an online educational module and be recruited to complete an online survey at baseline and 18 months.
EHR clinical decision support nudges: Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
Brief clinician education: Clinicians will be invited to view brief education material.
|
|---|---|---|
|
General disorders
Poor diabetes control
|
1.6%
11/668 • These adverse event data were collected over 18-month trial intervention period.
All adverse event outcomes were systematically queried for using electronic health record data. Each adverse event is for a specific, separate clinical outcome. The denominators of patients 'at risk' differ by adverse event. For example, male patients who were included in denominator for diabetes outcomes are not 'at risk' for interventions or outcome denominators aimed at urine studies for female patients.
|
2.8%
22/782 • These adverse event data were collected over 18-month trial intervention period.
All adverse event outcomes were systematically queried for using electronic health record data. Each adverse event is for a specific, separate clinical outcome. The denominators of patients 'at risk' differ by adverse event. For example, male patients who were included in denominator for diabetes outcomes are not 'at risk' for interventions or outcome denominators aimed at urine studies for female patients.
|
Additional Information
Stephen D. Persell, MD, MPH, FACP
Northwestern University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place