NCT04289753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37,134

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 16, 2023

Completed
Last Updated

August 16, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

February 26, 2020

Results QC Date

June 1, 2023

Last Update Submit

July 24, 2023

Conditions

Prostate Specific Antigen ScreeningAsymptomatic BacteriuriaType 2 Diabetes

Keywords

GeriatricsQuality of care

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    18 months

Secondary Outcomes (6)

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

    18 months

  • Rate of UTI Requiring Hospital Care Among Women 65 and Over Following an Office Visit

    18 months

  • Rate of Hyperglycemia Requiring Hospital Care Following Clinical Decision Support Exposure

    18 months

  • Rate of Hyperglycemia Requiring Hospital Care Among Previously Tightly Controlled

    18 months

  • Rate of Poor Diabetes Control Among Previously Tightly Controlled

    18 months

  • +1 more secondary outcomes

Other Outcomes (18)

  • PSA Screening in Older Men

    19-30 months

  • Urine Testing for Non-specific Reasons

    19-30 months

  • Diabetes Overtreatment in the Elderly

    19-30 months

  • +15 more other outcomes

Study Arms (2)

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.

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.

Behavioral: EHR clinical decision support nudgesBehavioral: Brief clinician education

Interventions

EHR clinical decision support nudgesBEHAVIORAL

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

Clinical decision support nudges and brief clinician education
Brief clinician educationBEHAVIORAL

Clinicians will be invited to view brief education material.

Brief clinician educationClinical decision support nudges and brief clinician education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Northwestern Medicine primary care clinician who sees patients under department code of a randomized clinic

You may not qualify if:

  • Resident physicians will be excluded
  • Clinicians who participated in pilot study of these interventions
  • Clinician study investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Persell 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.

    PMID: 38315997DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Stephen D. Persell, MD, MPH, FACP
Organization
Northwestern University
spersell@nm.org
3125036464

Study Officials

  • Stephen D. Persell, MD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster-randomized by primary care clinic using a constrained randomization process.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 26, 2020

First Posted

February 28, 2020

Study Start

September 1, 2020

Primary Completion

March 1, 2022

Study Completion

September 30, 2022

Last Updated

August 16, 2023

Results First Posted

August 16, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations

US(1)