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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03704389
Other study ID # STU00205722
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 17, 2019
Est. completion date August 18, 2019

Study information

Verified date September 2020
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The risks and benefits of many diagnostic approaches and treatments differ for older adults compared to middle aged adults. When diagnostic and therapeutic strategies are misapplied to older adults this can lead to increased morbidity and mortality. Well established examples where clinicians do not often follow best practices in the care of older adults include those identified by the American Geriatrics Society for the Choosing Wisely initiative: 1) testing and treatment for asymptomatic bacteriuria, 2) prostate specific antigen testing in older men without prostate cancer, and 3) overuse of insulin or oral hypoglycemics for type 2 diabetes.

Clinical decision support nudges, informed by social psychology and delivered via electronic health records (EHRs), are promising strategies to reduce the misuse of services in cases where optimal utilization may not be zero but should be well below current practice. These interventions seek to influence conscious and unconscious drivers of clinical decision making, are low cost to implement and disseminate, and can be incorporated into existing delivery systems. In the R21 phase of this Behavioral Economics Applications to Geriatrics Leveraging EHRs (BEAGLE) study, we will: select EHR delivered nudges to address 3 topics of potential misuse in older adults based on the main psychological drivers of overuse identified in interviews with high-using clinicians; develop and pilot test decision support tools within a health systems' EHR to understand technical feasibility, work flow fit, preliminary impact on clinical outcomes, and clinician acceptability; and develop and validate electronic clinical quality measures of potential overuse/misuse related to the care of older adults.


Description:

The risks and benefits of many diagnostic approaches and treatments differ for older adults compared to middle aged adults. When diagnostic and therapeutic strategies are misapplied to older adults this can lead to increased morbidity and mortality. Well-established examples where clinicians do not often follow best practices in the care of older adults include those identified by the American Geriatrics Society for the Choosing Wisely initiative: 1) testing and treatment for asymptomatic bacteriuria, 2) prostate specific antigen testing in older men without prostate cancer, and 3) overuse of insulin or oral hypoglycemics for type 2 diabetes. There are several hypotheses as to why clinicians fail to incorporate best evidence into geriatric clinical care. First, they may underestimate downstream harms of testing which seems easy to do (e.g., a urinalysis for a non-specific symptom) or treatment that may be appropriate for younger patients (e.g. intensifying insulin to achieve tight control). Second, clinicians may overweigh the risks of not performing the action (e.g., missing cancer diagnosis, failing to diagnose UTI in a patient presenting without urinary tract symptoms). Third, clinicians may respond to real or perceived social norms (from patients and their families, other clinicians or both) that set expectations to behave in specific ways. Fourth, force of habit may lead clinicians to act in a way similar to how they have done in the past even if current evidence doesn't support it. And fifth, clinicians may overuse a test or treatment to avoid feeling they are expressing an ageist bias toward their patients. Clinical decision support nudges, informed by social psychology and delivered via electronic health records (EHRs), are promising strategies to reduce the misuse of services in cases where optimal utilization may not be zero but should be well below current practice. These interventions seek to influence conscious and unconscious drivers of clinical decision making, are low cost to implement and disseminate, and can be incorporated into existing delivery systems. In the R21 phase of this Behavioral Economics Applications to Geriatrics Leveraging EHRs (BEAGLE) study, we will: select EHR delivered nudges to address 3 topics of potential misuse in older adults based on the main psychological drivers of overuse identified in interviews with high-using clinicians; develop and pilot test decision support tools within a health systems' EHR to understand technical feasibility, work flow fit, preliminary impact on clinical outcomes, and clinician acceptability; and develop and validate electronic clinical quality measures of potential overuse/misuse related to the care of older adults.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date August 18, 2019
Est. primary completion date July 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Northwestern Medicine primary care clinician caring for adults

- Provides informed consent

Study Design


Intervention

Behavioral:
Clinical decision support
Clinical decision support nudges within the electronic health record

Locations

Country Name City State
United States Northwestern Medicine Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
Northwestern University 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
Primary Misuse of urinalysis or urine culture in older women Proportion of women aged 65 years and older who underwent a urinalysis and/or urine culture for suspected UTI who did not have genitourinary specific symptoms 6 months
Primary PSA testing in the elderly Proportion of men 76 and older with no history of prostate cancer who had a PSA test done during the measurement period 6 months
Primary Diabetes overtreatment in the elderly Proportion of diabetes patients 75 and older treated with insulin or oral hypoglycemic with hemoglobin A1c less than 7.0. 6 months
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