- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03253874
Pre-Operative Testing for Cataract Surgery Among Adults in LA County (CW-CATARACT)
Evaluation of a Choosing Wisely™ Intervention to Reduce Low Value Pre-Operative Care for Patients Undergoing Cataract Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
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Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inappropriate pre-operative testing (Clinical Labs)
Time Frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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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.
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1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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Inappropriate pre-operative testing (EKG)
Time Frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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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.
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1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
|
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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.
|
1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
|
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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.
|
1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse post-operative events (e.g., arrhythmia, hyperkalemia, etc).
Time Frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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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.
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1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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Time to Surgery
Time Frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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Wait-times starting from diagnosis of cataracts until surgery
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1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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Collaborators and Investigators
Investigators
- Principal Investigator: Catherine A. Sarkisian, MD, MSHS, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCLA IRB #16-000932
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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