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

Primary Purpose

Prostate Specific Antigen Screening, Asymptomatic Bacteriuria, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EHR clinical decision support nudges
Brief clinician education
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Specific Antigen Screening focused on measuring Geriatrics, Quality of care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Brief clinician education

Clinical decision support nudges and brief clinician education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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
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.
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.
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.
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

Full Information

First Posted
February 26, 2020
Last Updated
July 24, 2023
Sponsor
Northwestern University
Collaborators
University of Southern California, University of California, Los Angeles, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04289753
Brief Title
Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial
Acronym
BEAGLE R33
Official Title
Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
University of Southern California, University of California, Los Angeles, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Specific Antigen Screening, Asymptomatic Bacteriuria, Type 2 Diabetes
Keywords
Geriatrics, Quality of care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster-randomized by primary care clinic using a constrained randomization process.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief clinician education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Clinical decision support nudges and brief clinician education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EHR clinical decision support nudges
Intervention Description
Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
Intervention Type
Behavioral
Intervention Name(s)
Brief clinician education
Intervention Description
Clinicians will be invited to view brief education material.
Primary Outcome Measure Information:
Title
PSA Screening in Older Men
Description
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.
Time Frame
18 months
Title
Urine Testing for Non-specific Reasons
Description
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.
Time Frame
18 months
Title
Diabetes Overtreatment in the Elderly
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Rate of UTI Requiring Hospital Care Among Women 65 and Over Following Clinical Decision Support Exposure
Description
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.
Time Frame
18 months
Title
Rate of UTI Requiring Hospital Care Among Women 65 and Over Following an Office Visit
Description
Emergency department visit or hospitalization for an infection originating from the urinary tract within 28 days of any primary care office visit
Time Frame
18 months
Title
Rate of Hyperglycemia Requiring Hospital Care Following Clinical Decision Support Exposure
Description
Emergency department visit or hospitalization for hyperglycemia within 90 days of an index visit where the clinician was exposed to the diabetes decision support.
Time Frame
18 months
Title
Rate of Hyperglycemia Requiring Hospital Care Among Previously Tightly Controlled
Description
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.
Time Frame
18 months
Title
Rate of Poor Diabetes Control Among Previously Tightly Controlled
Description
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.
Time Frame
18 months
Title
Rate of Hypoglycemia Requiring Urgent Care Among Previously Tightly Controlled
Description
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
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
PSA Screening in Older Men
Description
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.
Time Frame
19-30 months
Title
Urine Testing for Non-specific Reasons
Description
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.
Time Frame
19-30 months
Title
Diabetes Overtreatment in the Elderly
Description
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.
Time Frame
19-30 months
Title
Rates of Prostate Biopsy
Description
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
Time Frame
18 months and 19-30 months
Title
Rate of Prostate MRI
Description
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
Time Frame
18 months and 19-30 months
Title
Rate of Prostate Cancer Diagnosis
Description
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
Time Frame
18 months and 19-30 months
Title
PSA Screening Done by Non PCP in Men Over 76 Years Old
Description
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.
Time Frame
18 months and 19-30 months
Title
PSA Screening in Men Aged 55 to 69 and Age 70 to 75
Description
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
Time Frame
18 months and 19-30 months
Title
Rates of Urinalysis and Urine Culture Use in Women 65 and Older
Description
Proportion of all women with one or more visit to an eligible clinic during the prior 12 months receiving urinalysis and/or urine culture
Time Frame
18 months and 19-30 months
Title
Rate of Treatment for Antibiotics for UTI in Women 65 and Older
Description
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.
Time Frame
18 months and 19-30 months
Title
Dose Reduction in Insulin, Sulfonylurea or Meglitinides
Description
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
Time Frame
18 months, 24 months
Title
PSA Screening in Older Men by Race
Description
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.
Time Frame
18 months
Title
PSA Screening in Older Men by Ethnicity
Description
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.
Time Frame
18 months
Title
Urine Testing for Non-specific Reasons by Race
Description
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.
Time Frame
18 months
Title
Urine Testing for Non-specific Reasons by Ethnicity
Description
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.
Time Frame
18 months
Title
Diabetes Overtreatment in the Elderly by Sex
Description
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.
Time Frame
18 months
Title
Diabetes Overtreatment in the Elderly by Race
Description
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.
Time Frame
18 months
Title
Diabetes Overtreatment in the Elderly by Ethnicity
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen D. Persell, MD, MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.

Learn more about this trial

Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial

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