Last reviewed · How we verify

NCT04104256

Using Behavioral Economics to Reduce Low-Value Care

Completed NA Results posted Last updated 19 September 2024
What this trial tests

NA trial testing Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op tests in Pre-Operative Testing for Cataract Surgery in 1,045 participants. Completed in 14 August 2023.

Timeline
24 June 2021
Primary endpoint
11 April 2023
14 August 2023

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposehealth services research
Enrollment1,045
Start date24 June 2021
Primary completion11 April 2023
Estimated completion14 August 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

18 and older, any sex, with Pre-Operative Testing for Cataract Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pre-Operative Testing Change Primary · Pre-intervention (Baseline), Post-Intervention (12 months)

Change in percentage of patients undergoing pre-operative testing (labs, EKG, CXR)

Pre
GroupValue95% CI
Alert 187.4± 33.2
Alert 285.0± 35.8
Alert 386.1± 34.6
Control85.4± 35.4
Post
GroupValue95% CI
Alert 184.6± 36.2
Alert 280.3± 39.9
Alert 379.8± 40.3
Control83.5± 37.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Post-Intervention (3 Months) Patients were monitored for the completion of their cataract surgery following their pre-op visit. Adverse events were then monitored/assessed for 12 weeks following the completion of their cataract surgery.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Alert 1
Serious: 11/269 (4%)
Deaths: 1/269
Alert 2
Serious: 4/267 (1%)
Deaths: 3/267
Alert 3
Serious: 4/272 (1%)
Deaths: 0/272
Control
Serious: 12/237 (5%)
Deaths: 2/237

Serious adverse events (1 terms)

ReactionSystemAlert 1Alert 2Alert 3Control
Inpatient AdmissionGeneral disorders
Other adverse events (1 terms — click to expand)

ReactionSystemAlert 1Alert 2Alert 3Control
Emergency Department visits that did not require admissionsGeneral disorders

Most-reported serious reactions: Inpatient Admission.

Data from ClinicalTrials.gov NCT04104256 adverse events section.

Sponsor's own description

There is strong consensus - based on robust randomized trial data - that routine pre-operative (pre-op) testing for cataract surgery is inappropriate. Despite these widely endorsed evidence-based recommendations, most seniors undergoing cataract surgery still receive unnecessary blood testing, EKGs, and chest X-rays (CXRs); another substantial percentage even undergo nonindicated cardiac stress tests. We will integrate three new best practice alert (BPA) nudges into the University of California, Los Angeles (UCLA) Health electronic health record (EHR). The nudges are informed by behavioral economic theory and are designed to alter the choice architecture for physicians to decrease the rate of pre-op test ordering while still preserving clinician autonomy. We will conduct a pragmatic trial to evaluate whether these BPA nudges reduce low-value pre-op testing for cataract surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Protocol for pragmatic randomised trial: integrating electronic health record-based behavioural economic 'nudges' into the electronic health record to reduce preoperative testing for patients undergoing cataract surgery.
    Ahmadi A, Sorensen A, Villaflores CWA, Mafi JN, et al · · 2021 · cited 2× · PMID 34732478 · DOI 10.1136/bmjopen-2021-049568

Verify or expand the search:

Other University of California, Los Angeles trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04104256.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing