Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03253874
Other study ID # UCLA IRB #16-000932
Secondary ID
Status Completed
Phase N/A
First received November 15, 2016
Last updated August 15, 2017
Start date October 2014
Est. completion date April 2016

Study information

Verified date August 2017
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1798
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of California, Los Angeles LAC+USC Medical Center, Los Angeles County Department of Public Health

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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. 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
Secondary Time to Surgery Wait-times starting from diagnosis of cataracts until surgery 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
See also
  Status Clinical Trial Phase
Completed NCT04685538 - Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification. Phase 3
Recruiting NCT06060041 - IC-8 Apthera IOL New Enrollment Post Approval Study
Recruiting NCT05518539 - Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
Recruiting NCT05271942 - Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods N/A
Active, not recruiting NCT04778501 - PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia N/A
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT03751033 - Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings N/A
Completed NCT02529488 - Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00 N/A
Completed NCT04539548 - A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract Phase 3
Completed NCT03740659 - Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery Phase 2
Completed NCT03494257 - Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification N/A
Completed NCT05119127 - Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome. N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT03739528 - Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery Phase 3
Completed NCT02888210 - A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery Phase 3
Completed NCT03356847 - Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery N/A
Completed NCT04332640 - Clinical Evaluation of the Next Generation Phaco System N/A
Recruiting NCT03638726 - Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification Phase 4
Completed NCT03050697 - Evaluation of the Safety and Performance of the HARMONI® Toric Lens N/A