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

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ClinicalTrials.gov Identifier: NCT03253874
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
Los Angeles County Department of Public Health
LAC+USC Medical Center
Information provided by (Responsible Party):
Catherine A. Sarkisian, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Cataract Behavioral: No Pre-Op Testing for Cataract Surgeries Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1798 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Choosing Wisely™ Intervention to Reduce Low Value Pre-Operative Care for Patients Undergoing Cataract Surgery
Study Start Date : October 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Intervention Site-LAC+USC Medical Center
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
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.

No Intervention: Control Site--Harbor-UCLA Medical Center
In this arm or study site, patients will undergo standard of care for cataract surgery without any new guidelines.



Primary Outcome Measures :
  1. Inappropriate pre-operative testing (Clinical Labs) [ Time Frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation ]
    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.

  2. Inappropriate pre-operative testing (EKG) [ Time Frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation ]
    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.

  3. Inappropriate pre-operative testing (Chest X-rays) [ Time Frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation ]
    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.

  4. Inappropriate pre-operative testing (Provider Visits) [ Time Frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation ]
    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 :
  1. Adverse post-operative events (e.g., arrhythmia, hyperkalemia, etc). [ Time Frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation ]
    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.

  2. Time to Surgery [ Time Frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation ]
    Wait-times starting from diagnosis of cataracts until surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253874


Sponsors and Collaborators
University of California, Los Angeles
Los Angeles County Department of Public Health
LAC+USC Medical Center
Investigators
Principal Investigator: Catherine A. Sarkisian, MD, MSHS University of California, Los Angeles

Responsible Party: Catherine A. Sarkisian, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03253874     History of Changes
Other Study ID Numbers: UCLA IRB #16-000932
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Keywords provided by Catherine A. Sarkisian, University of California, Los Angeles:
Pre-operative Testing
Cataract Surgery
Health Service Research
Low-Value Care
Safety-Net Hospital

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases