Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial

Type 2 Diabetes Clinical Trial

— BEAGLE R33  

Official title:

Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289753
• Other study ID #: STU00210358
• Secondary ID: R33AG057383
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37134
• Est. completion date: September 30, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Bacteriuria
• Bacteriuria
• Prostate Specific Antigen Screening
• Type 2 Diabetes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	National Institute on Aging (NIA), University of California, Los Angeles, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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