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Pre-Operative Testing for Cataract Surgery Among Adults in LA County (CW-CATARACT)

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
No Pre-Op Testing for Cataract Surgeries
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cataract focused on measuring Pre-operative Testing, Cataract Surgery, Health Service Research, Low-Value Care, Safety-Net Hospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Site-LAC+USC Medical Center

    Control Site--Harbor-UCLA Medical Center

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Adverse post-operative events (e.g., arrhythmia, hyperkalemia, etc).
    Complications or adverse event s during surgery, and after surgery (30 day). New ICD Diagnostic codes will be explore 30 days after surgery or date of surgery to determine if there are any adverse events/surgical complications. Adverse events post-operative will be monitored to ensure the intervention is not leading to harm.
    Time to Surgery
    Wait-times starting from diagnosis of cataracts until surgery

    Full Information

    First Posted
    November 15, 2016
    Last Updated
    August 15, 2017
    Sponsor
    University of California, Los Angeles
    Collaborators
    Los Angeles County Department of Public Health, LAC+USC Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03253874
    Brief Title
    Pre-Operative Testing for Cataract Surgery Among Adults in LA County
    Acronym
    CW-CATARACT
    Official Title
    Evaluation of a Choosing Wisely™ Intervention to Reduce Low Value Pre-Operative Care for Patients Undergoing Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    Los Angeles County Department of Public Health, LAC+USC Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Pre-operative testing for cataract surgery provides no discernible benefit to patients, increases risk of harm, and substantially raises healthcare costs-representing the quintessential example of low value care. Despite multiple randomized controlled trials demonstrating no benefit, physicians continue to routinely order pre-operative testing for most patients undergoing cataract surgery. Supported by the American Board of Internal Medicine's Choosing Wisely™ campaign to reduce low value care, a quality improvement (QI) initiative to reduce pre-operative visits and testing for cataract surgery at LAC+USC Medical Center, a safety-net health system serving Los Angeles County's under-resourced populations and control site, Harbor-UCLA Medical Center will be evaluated. Using Institute for Healthcare Improvement PDSA (plan, do, study, act) cycle techniques, the QI team implemented the following steps (1) review randomly sampled charts on cataract surgery patients, (2) show local data on over-testing to hospital leadership, (3) obtain buy-in from the chairs of anesthesia and ophthalmology, (4) recruit an ophthalmology resident champion, and (5) empower nurses to stop scheduling pre-operative visits for cataract surgery. On October 13th, 2015, at LAC+USC Medical Center but not Harbor-UCLA, the resident champion and department chairs emailed "new" clinical guidelines for pre-operative testing to faculty, trainees, and staff, and specifically promoted avoidance of pre-operative testing for cataract surgery, except for guideline-concordant point-of-care glucose testing for patients with diabetes and potassium testing for patients with chronic kidney disease. Evaluation of this quality improvement initiative will consists of a quasi-experimental pre-post time series analysis. Primary outcomes include pre-operative medical visits, laboratory testing, chest X-rays and electrocardiograms within 80 days of surgery (chart review revealed the maximum duration of pre-operative testing was 80 days) for patients undergoing cataract surgery before and after the intervention. Multivariable generalized linear models that account for clustering by clinician and adjust for patient and provider characteristics and time (in months) will be used. .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    Pre-operative Testing, Cataract Surgery, Health Service Research, Low-Value Care, Safety-Net Hospital

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    1798 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Site-LAC+USC Medical Center
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Site--Harbor-UCLA Medical Center
    Arm Type
    No Intervention
    Arm Description
    In this arm or study site, patients will undergo standard of care for cataract surgery without any new guidelines.
    Intervention Type
    Behavioral
    Intervention Name(s)
    No Pre-Op Testing for Cataract Surgeries
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Inappropriate pre-operative testing (Clinical Labs)
    Description
    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.
    Time Frame
    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
    Title
    Inappropriate pre-operative testing (EKG)
    Description
    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.
    Time Frame
    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
    Title
    Inappropriate pre-operative testing (Chest X-rays)
    Description
    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.
    Time Frame
    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
    Title
    Inappropriate pre-operative testing (Provider Visits)
    Description
    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.
    Time Frame
    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
    Secondary Outcome Measure Information:
    Title
    Adverse post-operative events (e.g., arrhythmia, hyperkalemia, etc).
    Description
    Complications or adverse event s during surgery, and after surgery (30 day). New ICD Diagnostic codes will be explore 30 days after surgery or date of surgery to determine if there are any adverse events/surgical complications. Adverse events post-operative will be monitored to ensure the intervention is not leading to harm.
    Time Frame
    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
    Title
    Time to Surgery
    Description
    Wait-times starting from diagnosis of cataracts until surgery
    Time Frame
    1 year: 6 months prior to guideline implantation & 6 month after guideline implementation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Any DHS patient scheduled for cataract surgery over the 24 month time period Exclusion Criteria: DHS patient who are not undergoing cataract surgery over the last 24 months period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine A. Sarkisian, MD, MSHS
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Pre-Operative Testing for Cataract Surgery Among Adults in LA County

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