Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial (BEAGLE R33)

Investigators will evaluate clinical decision support nudges informed by behavioral science and directed at primary care clinicians. These will be used to reduce commonly misused, and potentially harmful, diagnostic and therapeutic actions that occur in the care of older adults (e.g. overtreatment of type 2 diabetes, misuse of PSA screening, misuse of urine testing in women with nonspecific symptoms or no symptoms.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Asymptomatic Bacteriuria; Prostate Specific Antigen Screening
• Intervention / Treatment: Behavioral: Brief clinician education; Behavioral: EHR clinical decision support nudges

Detailed Description

Diagnostic and therapeutic strategies misapplied to older adults can lead to increased morbidity and mortality. Despite recommendations from the American Geriatrics Society for the Choosing Wisely Initiative, there are clear examples where clinicians do not often follow best practices leading to patient harm. These include: (1) testing and treatment for asymptomatic bacteriuria (ASB) in older women, (2) prostate specific antigen (PSA) screening in older men, and (3) aggressive treatment with insulin or oral hypoglycemics for type 2 diabetes.

Clinical decision support nudges, informed by behavioral economics and social psychology and delivered via electronic health records (EHRs), are promising strategies to reduce the misuse of services. Behavioral economics-informed interventions influence conscious and unconscious drivers of decision making, are low cost, and can be incorporated into existing systems.

This randomized controlled trial will evaluate the effects of three clinical decision support nudges on three clinical quality measures, indicators of patient safety, and clinician attitudes.

• Study Type: Interventional
• Enrollment (Actual): 37134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Northwestern Medicine primary care clinician who sees patients under department code of a randomized clinic

Exclusion Criteria:

• Resident physicians will be excluded
• Clinicians who participated in pilot study of these interventions
• Clinician study investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Brief clinician education; Clinicians will be invited to view brief education material.
Experimental: 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.	Behavioral: Brief clinician education; Clinicians will be invited to view brief education material.; Behavioral: EHR clinical decision support nudges; Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA Screening in Older Men	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.	18 months
Urine Testing for Non-specific Reasons	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.	18 months
Diabetes Overtreatment in the Elderly	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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of UTI Requiring Hospital Care Among Women 65 and Over Following Clinical Decision Support Exposure	Emergency 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.	18 months
Rate of UTI Requiring Hospital Care Among Women 65 and Over Following an Office Visit	Emergency department visit or hospitalization for an infection originating from the urinary tract within 28 days of any primary care office visit	18 months
Rate of Hyperglycemia Requiring Hospital Care Following Clinical Decision Support Exposure	Emergency department visit or hospitalization for hyperglycemia within 90 days of an index visit where the clinician was exposed to the diabetes decision support.	18 months
Rate of Hyperglycemia Requiring Hospital Care Among Previously Tightly Controlled	Emergency 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.	18 months
Rate of Poor Diabetes Control Among Previously Tightly Controlled	Occurrence 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.	18 months
Rate of Hypoglycemia Requiring Urgent Care Among Previously Tightly Controlled	Emergency 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	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA Screening in Older Men	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.	19-30 months
Urine Testing for Non-specific Reasons	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.	19-30 months
Diabetes Overtreatment in the Elderly	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.	19-30 months
Rates of Prostate Biopsy	Rate 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	18 months and 19-30 months
Rate of Prostate MRI	Rate 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	18 months and 19-30 months
Rate of Prostate Cancer Diagnosis	Rate 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	18 months and 19-30 months
PSA Screening Done by Non PCP in Men Over 76 Years Old	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 ordered by a non-primary care clinician and who are without a diagnosis or procedure suggesting a history of prostate cancer.	18 months and 19-30 months
PSA Screening in Men Aged 55 to 69 and Age 70 to 75	Measure 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	18 months and 19-30 months
Rates of Urinalysis and Urine Culture Use in Women 65 and Older	Proportion of all women with one or more visit to an eligible clinic during the prior 12 months receiving urinalysis and/or urine culture	18 months and 19-30 months
Rate of Treatment for Antibiotics for UTI in Women 65 and Older	Proportion 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.	18 months and 19-30 months
Dose Reduction in Insulin, Sulfonylurea or Meglitinides	Proportion of patients 75 years old and older with initial HbA1c <7.0 and treated with insulin, sulfonylurea or meglitinides who have a dose reduction	18 months, 24 months
PSA Screening in Older Men by Race	NIH-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.	18 months
PSA Screening in Older Men by Ethnicity	NIH-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.	18 months
Urine Testing for Non-specific Reasons by Race	NIH-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.	18 months
Urine Testing for Non-specific Reasons by Ethnicity	NIH-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.	18 months
Diabetes Overtreatment in the Elderly by Sex	NIH-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.	18 months
Diabetes Overtreatment in the Elderly by Race	NIH-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.	18 months
Diabetes Overtreatment in the Elderly by Ethnicity	NIH-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.	18 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of California, Los Angeles; National Institute on Aging (NIA); University of Southern California
• Investigators: Principal Investigator: Stephen D. Persell, MD, MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Geriatrics; Quality of care
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bacteriuria
• Other Study ID Numbers: STU00210358; R33AG057383 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No