Clinical trial NCT03253874: Pre-Operative Testing for Cataract Surgery Among Adults in LA County
Official title: Evaluation of a Choosing Wisely™ Intervention to Reduce Low Value Pre-Operative Care for Patients Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Pre-operative Testing
Cataract Surgery
Health Service Research
Low-Value Care
Safety-Net Hospital
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Los Angeles County Department of Public Health
name: LAC+USC Medical Center
First posted: 2017-08-18
Enrollment: 1798
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

.

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

Primary outcomes:
measure: Inappropriate pre-operative testing (Clinical Labs)
timeFrame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
measure: Inappropriate pre-operative testing (EKG)
timeFrame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
measure: Inappropriate pre-operative testing (Chest X-rays)
timeFrame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
measure: Inappropriate pre-operative testing (Provider Visits)
timeFrame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
Secondary outcomes:
measure: Adverse post-operative events (e.g., arrhythmia, hyperkalemia, etc).
timeFrame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
measure: Time to Surgery
timeFrame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Catherine A. Sarkisian, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References: