NCT03253874

Brief Summary

A multi-disciplinary intervention will reduce inappropriate preoperative testing for cataract surgery. Despite multiple rigorous randomized controlled trials and meta-analyses showing that pre-operative testing for cataract surgery does not improve outcomes, pre-operative testing has not declined. A quality improvement initiative, which includes gaining senior leadership support, changing the culture of care, and elimination of pre-operative consultation visits for cataract surgery, to reduce inappropriate pre-operative testing. Quasi-experimental difference-in-difference analysis comparing the intervention arm (LAC+USC Medical Center) with the control arm (Harbor-UCLA Medical Center), 6 months prior and 6 months after the intervention. Generalized estimating equation models will adjust for age, gender, race/ethnicity, comorbidities and cluster by site.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,798

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

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

Study Start

First participant enrolled

October 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

1.5 years

First QC Date

November 15, 2016

Last Update Submit

August 15, 2017

Conditions

Keywords

Pre-operative TestingCataract SurgeryHealth Service ResearchLow-Value CareSafety-Net Hospital

Outcome Measures

Primary Outcomes (4)

  • Inappropriate pre-operative testing (Clinical Labs)

    Electronic health records will be used to identify patients with a CPT (procedure) code for cataract surgery. Using CPT (procedure) codes for pre-preoperative clinical laboratory tests (Comprehensive Metabolic Panel, CBC Plate Diff). Using CPT (procedure) codes for pre-preoperative EKGs procedures. Using CPT (procedure) codes for pre-preoperative Chest X-rays. Using CPT (procedure) codes for pre-preoperative Provider Visits (LVN/RN/PA) Visits.

    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation

  • Inappropriate pre-operative testing (EKG)

    Electronic health records will be used to identify patients with a CPT (procedure) code for cataract surgery. Using CPT (procedure) codes for pre-preoperative EKGs procedures.

    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation

  • Inappropriate pre-operative testing (Chest X-rays)

    Electronic health records will be used to identify patients with a CPT (procedure) code for cataract surgery. Using CPT (procedure) codes for pre-preoperative Chest X-rays.

    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation

  • Inappropriate pre-operative testing (Provider Visits)

    Electronic health records will be used to identify patients with a CPT (procedure) code for cataract surgery. Using CPT (procedure) codes for pre-preoperative Provider Visits (LVN/RN/PA) Visits.

    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation

Secondary Outcomes (2)

  • Adverse post-operative events (e.g., arrhythmia, hyperkalemia, etc).

    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation

  • Time to Surgery

    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation

Study Arms (2)

Intervention Site-LAC+USC Medical Center

EXPERIMENTAL

In this arm or study site,new guidelines are disseminated to all residents attending and faculty physicians within the department of Ophthalmology and Anesthesiology. New guidelines call for the across the board elimination of pre-operative testing and visits for patients undergoing cataract surgery.

Behavioral: No Pre-Op Testing for Cataract Surgeries

Control Site--Harbor-UCLA Medical Center

NO INTERVENTION

In this arm or study site, patients will undergo standard of care for cataract surgery without any new guidelines.

Interventions

Supported by the American Board of Internal Medicine's Choosing Wisely™ campaign to reduce low value care , the interventions aims to reduce pre-operative visits and testing for patients undergoing cataract surgeries.

Intervention Site-LAC+USC Medical Center

Eligibility Criteria

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

You may qualify if:

  • Any DHS patient scheduled for cataract surgery over the 24 month time period

You may not qualify if:

  • DHS patient who are not undergoing cataract surgery over the last 24 months period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Catherine A. Sarkisian, MD, MSHS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2016

First Posted

August 18, 2017

Study Start

October 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 18, 2017

Record last verified: 2017-08