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Completed

NCT Number: NCT04289753

Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial

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.

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Key information

Conditions

Prostate Specific Antigen Screening Asymptomatic Bacteriuria Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EHR clinical decision support nudges

Behavioral

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

Brief clinician education

Behavioral

Clinicians will be invited to view brief education material.

Primary outcomes

  1. PSA Screening in Older Men

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Rate of UTI Requiring Hospital Care Among Women 65 and Over Following Clinical Decision Support Exposure

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. PSA Screening in Older Men

    Time frame: 19-30 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

    Time frame: 19-30 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

    Time frame: 19-30 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

    Time frame: 18 months and 19-30 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

    Time frame: 18 months and 19-30 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

    Time frame: 18 months and 19-30 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

    Time frame: 18 months and 19-30 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

    Time frame: 18 months and 19-30 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

    Time frame: 18 months and 19-30 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

    Time frame: 18 months and 19-30 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

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

Registry information

Acronym: BEAGLE R33

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2020
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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