Prostate Specific Antigen ScreeningBEAGLE R33NCT04289753
Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial
A study testing EHR clinical decision support nudges and Brief clinician education in people with Prostate Specific Antigen Screening and Asymptomatic Bacteriuria, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Specific Antigen Screening, Asymptomatic Bacteriuria, Type 2 Diabetes
- What is being tested?
- EHR clinical decision support nudges and Brief clinician education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37,134 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Northwestern Medicine primary care clinician who sees patients under department code of a randomized clinic
Who cannot join
- Resident physicians will be excluded
- Clinicians who participated in pilot study of these interventions
- Clinician study investigators
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- EHR clinical decision support nudges, Brief clinician education
- Keywords
- Geriatrics, Quality of care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR clinical decision support nudgesBehavioural
Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
Brief clinician educationBehavioural
Clinicians will be invited to view brief education material.
| Study group | Role | What they receive |
|---|---|---|
| Brief clinician education | Active comparator | 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. Receives: Behavioral: Brief clinician education |
| Clinical decision support nudges and brief clinician education | Experimental | 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. Receives: Behavioral: EHR clinical decision support nudges; Behavioral: Brief clinician education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
Secondary outcomes (6)
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.
Measured: 18 months
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
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Sep 2020
- Primary completion1 Mar 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate Specific Antigen ScreeningStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized by primary care clinic using a constrained randomization process.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37,134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, University of California, Los Angeles, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Stephen Persell, MD, MPH, Northwestern University
- Investigators
- Stephen D. Persell, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289753
- Sponsor's protocol ID
- STU00210358
- Other IDs
- R33AG057383
- Acronym
- BEAGLE R33
- Status last verified
- Jul 2023
- First submitted
- 26 Feb 2020
- Last updated
- 16 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Duong N, Lee JY, Peprah Y, Brown T, Linder JA, Doctor JN, Meeker D, Fox CR, Goldstein NJ, Persell SD, Petito LC. Changing Clinician Behavior in Geriatrics: Point-of-Care Alerts for Prostate-Specific Antigen Screening. Am J Prev Med. 2026 Jul;71(1):108305. doi: 10.1016/j.amepre.2026.108305. Epub 2026 Feb 10.
PubMed 41672386Persell SD, Petito LC, Lee JY, Meeker D, Doctor JN, Goldstein NJ, Fox CR, Rowe TA, Linder JA, Chmiel R, Peprah YA, Brown T. Reducing Care Overuse in Older Patients Using Professional Norms and Accountability : A Cluster Randomized Controlled Trial. Ann Intern Med. 2024 Mar;177(3):324-334. doi: 10.7326/M23-2183. Epub 2024 Feb 6.
PubMed 38315997
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial
- ClinicalTrials.gov ID
- NCT04289753
- Acronym / sponsor ID
- BEAGLE R33 / STU00210358
- Keywords
- Geriatrics, Quality of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37,134 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Southern California, University of California, Los Angeles, National Institute on Aging (NIA)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized by primary care clinic using a constrained randomization process.
| Arm | Type | Receives |
|---|---|---|
| Brief clinician education | Active comparator | Behavioral: Brief clinician educationClinicians 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. |
| Clinical decision support nudges and brief clinician education | Experimental | Behavioral: EHR clinical decision support nudges, Behavioral: Brief clinician educationClinicians 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Northwestern Medicine primary care clinician who sees patients under department code of a randomized clinic
Key exclusion criteria (3 listed)
- Resident physicians will be excluded
- Clinicians who participated in pilot study of these interventions
- Clinician study investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHR clinical decision support nudgesClinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria. | Behavioural | Clinical decision support nudges and brief clinician education |
| Brief clinician educationClinicians will be invited to view brief education material. | Behavioural | Brief clinician education, Clinical decision support nudges and brief clinician education |
Primary outcome
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.
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.
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.
6 secondary outcomes
Rate of UTI Requiring Hospital Care Among Women 65 and Over Following Clinical Decision Support Exposure
Time frame: 18 months
Rate of UTI Requiring Hospital Care Among Women 65 and Over Following an Office Visit
Time frame: 18 months
Rate of Hyperglycemia Requiring Hospital Care Following Clinical Decision Support Exposure
Time frame: 18 months
Rate of Hyperglycemia Requiring Hospital Care Among Previously Tightly Controlled
Time frame: 18 months
Rate of Poor Diabetes Control Among Previously Tightly Controlled
Time frame: 18 months
Rate of Hypoglycemia Requiring Urgent Care Among Previously Tightly Controlled
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41672386Duong N, Lee JY, Peprah Y, Brown T, Linder JA, Doctor JN, Meeker D, Fox CR, Goldstein NJ, Persell SD, Petito LC. Changing Clinician Behavior in Geriatrics: Point-of-Care Alerts for Prostate-Specific Antigen Screening. Am J Prev Med. 2026 Jul;71(1):108305. doi: 10.1016/j.amepre.2026.108305. Epub 2026 Feb 10.
- Derived from this study: PubMed 38315997Persell SD, Petito LC, Lee JY, Meeker D, Doctor JN, Goldstein NJ, Fox CR, Rowe TA, Linder JA, Chmiel R, Peprah YA, Brown T. Reducing Care Overuse in Older Patients Using Professional Norms and Accountability : A Cluster Randomized Controlled Trial. Ann Intern Med. 2024 Mar;177(3):324-334. doi: 10.7326/M23-2183. Epub 2024 Feb 6.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D. Persell, MD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR clinical decision support nudges and Brief clinician education in people with Prostate Specific Antigen Screening and Asymptomatic Bacteriuria, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA Screening in Older Men (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04289753, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.