NCT04104256

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,045

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

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

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 24, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

September 24, 2019

Results QC Date

May 28, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

Low Value CareCataract SurgeryBehavioral Economics

Outcome Measures

Primary Outcomes (1)

  • Pre-Operative Testing Change

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

    Pre-intervention (Baseline), Post-Intervention (12 months)

Secondary Outcomes (6)

  • Pre-Operative Testing Change

    Pre-intervention (Baseline), Post-Intervention (12 months)

  • Pre-Operative Testing Change for Specific Categories of Tests

    Pre-intervention (Baseline), Post-Intervention (12 months)

  • Physician Experience Survey Results

    Post-Intervention (12 months)

  • System-level Change - Surgery Cancellations

    Baseline, 12 months

  • System-level Change - Cost Savings

    Pre-intervention (Baseline), Post-Intervention (12 months)

  • +1 more secondary outcomes

Study Arms (4)

Alert 1

EXPERIMENTAL

Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #1 group.

Behavioral: Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op tests

Alert 2

EXPERIMENTAL

Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #2 group.

Behavioral: Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op tests

Alert 3

EXPERIMENTAL

Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #3 group.

Behavioral: Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op tests

Control

EXPERIMENTAL

Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Control group. Encounter continues as usual.

Other: Usual Care

Interventions

Patients will receive usual care from their physicians.

Also known as: Control
Control

Nudge 1: * UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing. * UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery. * Routine pre-op tests are inappropriate. * Routine pre-op tests do NOT increase patient safety and go AGAINST local and national guidelines Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES"

Alert 1

Nudge #2: * UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing. * UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery. * Routine pre-op tests are inappropriate. * Routine pre-operative tests can increase the patient's out-of-pocket costs without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines * Nudge includes "hard stop" before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES"

Alert 2

Nudge 3: * UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing. * UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery. * Routine pre-op tests are inappropriate. * Routine pre-operative tests can cause aggravation and psychological stress for the patient without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines * Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES"

Alert 3

Eligibility Criteria

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

You may qualify if:

  • Patient at UCLA undergoing cataract surgery, and receives pre-operative evaluation at UCLA Health

You may not qualify if:

  • Cataract surgery patients who get their pre-operative evaluation from non-UCLA physicians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Health

Los Angeles, California, 90095, United States

Location

Related Publications (8)

  • Keay L, Lindsley K, Tielsch J, Katz J, Schein O. Routine preoperative medical testing for cataract surgery. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007293. doi: 10.1002/14651858.CD007293.pub2.

    PMID: 19370681BACKGROUND
  • Keay L, Lindsley K, Tielsch J, Katz J, Schein O. Routine preoperative medical testing for cataract surgery. Cochrane Database Syst Rev. 2012 Mar 14;3(3):CD007293. doi: 10.1002/14651858.CD007293.pub3.

    PMID: 22419323BACKGROUND
  • Schein OD, Katz J, Bass EB, Tielsch JM, Lubomski LH, Feldman MA, Petty BG, Steinberg EP. The value of routine preoperative medical testing before cataract surgery. Study of Medical Testing for Cataract Surgery. N Engl J Med. 2000 Jan 20;342(3):168-75. doi: 10.1056/NEJM200001203420304.

    PMID: 10639542BACKGROUND
  • Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA, Dudley RA. Preoperative medical testing in Medicare patients undergoing cataract surgery. N Engl J Med. 2015 Apr 16;372(16):1530-8. doi: 10.1056/NEJMsa1410846.

    PMID: 25875258BACKGROUND
  • Schein OD, Cassard SD, Tielsch JM, Gower EW. Cataract surgery among Medicare beneficiaries. Ophthalmic Epidemiol. 2012 Oct;19(5):257-64. doi: 10.3109/09286586.2012.698692.

    PMID: 22978526BACKGROUND
  • Rumball-Smith J, Shekelle PG, Bates DW. Using the Electronic Health Record to Understand and Minimize Overuse. JAMA. 2017 Jan 17;317(3):257-258. doi: 10.1001/jama.2016.18609. No abstract available.

    PMID: 28114561BACKGROUND
  • Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.

    PMID: 26864410BACKGROUND
  • Ahmadi A, Sorensen A, Villaflores CWA, Mafi JN, Vangala SS, Hofer IS, Bartlett JD, Cheng EM, Duval VF, Damberg C, Elashoff D, Goldstein NJ, Ladapo JA, Moore JM, Pessegueiro AM, Shu SB, Skootsky SA, Turner A, Sarkisian CA. 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. BMJ Open. 2021 Nov 3;11(11):e049568. doi: 10.1136/bmjopen-2021-049568.

Related Links

Results Point of Contact

Title
Project Manager
Organization
University of California Los Angeles, Division of General Internal Medicine and Health Services Research

Study Officials

  • Catherine A Sarkisian, MD, MSPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

June 24, 2021

Primary Completion

April 11, 2023

Study Completion

August 14, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations