BEAGLE R33: Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial

Sponsor
Northwestern University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04289753
Collaborator
University of Southern California (Other), University of California, Los Angeles (Other), National Institute on Aging (NIA) (NIH)
371
1
2
24.9
14.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: EHR clinical decision support nudges
  • Behavioral: Brief clinician education
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
371 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cluster-randomized by primary care clinic using a constrained randomization process.Cluster-randomized by primary care clinic using a constrained randomization process.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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: EHR clinical decision support nudges
Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.

Behavioral: Brief clinician education
Clinicians will be invited to view brief education material.

Outcome Measures

Primary Outcome Measures

  1. PSA screening in older men [18 months]

    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.

  2. Urine testing for non-specific reasons [18 months]

    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.

  3. Diabetes overtreatment in the elderly [18 months]

    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

  1. Rate of UTI requiring hospital care among women 65 and over following clinical decision support exposure [18 months]

    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.

  2. Rate of UTI requiring hospital care among women 65 and over following an office visit [18 months]

    Emergency department visit or hospitalization for an infection originating from the urinary tract within 28 days of any primary care office visit

  3. Rate of hyperglycemia requiring hospital care following clinical decision support exposure [18 months]

    Emergency department visit or hospitalization for hyperglycemia within 90 days of an index visit where the clinician was exposed to the diabetes decision support.

  4. Rate of hyperglycemia requiring hospital care among previously tightly controlled [18 months]

    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.

  5. Rate of poor diabetes control among previously tightly controlled [18 months]

    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.

  6. Rate of hypoglycemia requiring urgent care among previously tightly controlled [18 months]

    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

Other Outcome Measures

  1. PSA screening in older men [19-24 months]

    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.

  2. Urine testing for non-specific reasons [19-24 months]

    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.

  3. Diabetes overtreatment in the elderly [19-24 months]

    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.

  4. Rates of prostate biopsy [18 months and 19-24 months]

    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

  5. Rate of prostate MRI [18 months and 19-24 months]

    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

  6. Rate of prostate cancer diagnosis [18 months and 19-24 months]

    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

  7. PSA screening done by non PCP in men over 76 years old [18 months and 19-24 months]

    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.

  8. PSA screening in men aged 55 to 69 and age 70 to 75 [18 months and 19-24 months]

    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

  9. Rates of urinalysis and urine culture use in women 65 and older [18 months and 19-24 months]

    Proportion of all women with one or more visit to an eligible clinic during the prior 12 months receiving urinalysis and/or urine culture

  10. Rate of treatment for antibiotics for UTI in women 65 and older [18 months and 19-24 months]

    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.

  11. Dose reduction in insulin, sulfonylurea or meglitinides [18 months, 24 months]

    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

  12. PSA screening in older men by race [18 months]

    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.

  13. PSA screening in older men by ethnicity [18 months]

    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.

  14. Urine testing for non-specific reasons by race [18 months]

    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.

  15. Urine testing for non-specific reasons by ethnicity [18 months]

    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.

  16. Diabetes overtreatment in the elderly by sex [18 months]

    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.

  17. Diabetes overtreatment in the elderly by race [18 months]

    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. Diabetes overtreatment in the elderly by ethnicity [18 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern Medicine Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University
  • University of Southern California
  • University of California, Los Angeles
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Stephen D. Persell, MD, MPH, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephen Persell, MD, MPH, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier:
NCT04289753
Other Study ID Numbers:
  • STU00210358
  • R33AG057383
First Posted:
Feb 28, 2020
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stephen Persell, MD, MPH, Professor of Medicine, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022