<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03253874</url>
  </required_header>
  <id_info>
    <org_study_id>UCLA IRB #16-000932</org_study_id>
    <nct_id>NCT03253874</nct_id>
  </id_info>
  <brief_title>Pre-Operative Testing for Cataract Surgery Among Adults in LA County</brief_title>
  <acronym>CW-CATARACT</acronym>
  <official_title>Evaluation of a Choosing Wisely™ Intervention to Reduce Low Value Pre-Operative Care for Patients Undergoing Cataract Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Los Angeles County Department of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LAC+USC Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multi-disciplinary intervention will reduce inappropriate preoperative testing for cataract&#xD;
      surgery. Despite multiple rigorous randomized controlled trials and meta-analyses showing&#xD;
      that pre-operative testing for cataract surgery does not improve outcomes, pre-operative&#xD;
      testing has not declined. A quality improvement initiative, which includes gaining senior&#xD;
      leadership support, changing the culture of care, and elimination of pre-operative&#xD;
      consultation visits for cataract surgery, to reduce inappropriate pre-operative testing.&#xD;
      Quasi-experimental difference-in-difference analysis comparing the intervention arm (LAC+USC&#xD;
      Medical Center) with the control arm (Harbor-UCLA Medical Center), 6 months prior and 6&#xD;
      months after the intervention. Generalized estimating equation models will adjust for age,&#xD;
      gender, race/ethnicity, comorbidities and cluster by site.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-operative testing for cataract surgery provides no discernible benefit to patients,&#xD;
      increases risk of harm, and substantially raises healthcare costs-representing the&#xD;
      quintessential example of low value care. Despite multiple randomized controlled trials&#xD;
      demonstrating no benefit, physicians continue to routinely order pre-operative testing for&#xD;
      most patients undergoing cataract surgery.&#xD;
&#xD;
      Supported by the American Board of Internal Medicine's Choosing Wisely™ campaign to reduce&#xD;
      low value care, a quality improvement (QI) initiative to reduce pre-operative visits and&#xD;
      testing for cataract surgery at LAC+USC Medical Center, a safety-net health system serving&#xD;
      Los Angeles County's under-resourced populations and control site, Harbor-UCLA Medical Center&#xD;
      will be evaluated.&#xD;
&#xD;
      Using Institute for Healthcare Improvement PDSA (plan, do, study, act) cycle techniques, the&#xD;
      QI team implemented the following steps (1) review randomly sampled charts on cataract&#xD;
      surgery patients, (2) show local data on over-testing to hospital leadership, (3) obtain&#xD;
      buy-in from the chairs of anesthesia and ophthalmology, (4) recruit an ophthalmology resident&#xD;
      champion, and (5) empower nurses to stop scheduling pre-operative visits for cataract&#xD;
      surgery. On October 13th, 2015, at LAC+USC Medical Center but not Harbor-UCLA, the resident&#xD;
      champion and department chairs emailed &quot;new&quot; clinical guidelines for pre-operative testing to&#xD;
      faculty, trainees, and staff, and specifically promoted avoidance of pre-operative testing&#xD;
      for cataract surgery, except for guideline-concordant point-of-care glucose testing for&#xD;
      patients with diabetes and potassium testing for patients with chronic kidney disease.&#xD;
&#xD;
      Evaluation of this quality improvement initiative will consists of a quasi-experimental&#xD;
      pre-post time series analysis. Primary outcomes include pre-operative medical visits,&#xD;
      laboratory testing, chest X-rays and electrocardiograms within 80 days of surgery (chart&#xD;
      review revealed the maximum duration of pre-operative testing was 80 days) for patients&#xD;
      undergoing cataract surgery before and after the intervention.&#xD;
&#xD;
      Multivariable generalized linear models that account for clustering by clinician and adjust&#xD;
      for patient and provider characteristics and time (in months) will be used.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inappropriate pre-operative testing (Clinical Labs)</measure>
    <time_frame>1 year: 6 months prior to guideline implantation &amp; 6 month after guideline implementation</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inappropriate pre-operative testing (EKG)</measure>
    <time_frame>1 year: 6 months prior to guideline implantation &amp; 6 month after guideline implementation</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inappropriate pre-operative testing (Chest X-rays)</measure>
    <time_frame>1 year: 6 months prior to guideline implantation &amp; 6 month after guideline implementation</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inappropriate pre-operative testing (Provider Visits)</measure>
    <time_frame>1 year: 6 months prior to guideline implantation &amp; 6 month after guideline implementation</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse post-operative events (e.g., arrhythmia, hyperkalemia, etc).</measure>
    <time_frame>1 year: 6 months prior to guideline implantation &amp; 6 month after guideline implementation</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Surgery</measure>
    <time_frame>1 year: 6 months prior to guideline implantation &amp; 6 month after guideline implementation</time_frame>
    <description>Wait-times starting from diagnosis of cataracts until surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1798</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Intervention Site-LAC+USC Medical Center</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Site--Harbor-UCLA Medical Center</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this arm or study site, patients will undergo standard of care for cataract surgery without any new guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No Pre-Op Testing for Cataract Surgeries</intervention_name>
    <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.</description>
    <arm_group_label>Intervention Site-LAC+USC Medical Center</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any DHS patient scheduled for cataract surgery over the 24 month time period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DHS patient who are not undergoing cataract surgery over the last 24 months period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine A. Sarkisian, MD, MSHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Catherine A. Sarkisian</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pre-operative Testing</keyword>
  <keyword>Cataract Surgery</keyword>
  <keyword>Health Service Research</keyword>
  <keyword>Low-Value Care</keyword>
  <keyword>Safety-Net Hospital</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253874
org study id: UCLA IRB #16-000932
nct id: NCT03253874
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
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.

      .
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Inappropriate pre-operative testing (Clinical Labs)
time frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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.
measure: Inappropriate pre-operative testing (EKG)
time frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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.
measure: Inappropriate pre-operative testing (Chest X-rays)
time frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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.
measure: Inappropriate pre-operative testing (Provider Visits)
time frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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.
measure: Adverse post-operative events (e.g., arrhythmia, hyperkalemia, etc).
time frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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.
measure: Time to Surgery
time frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
description: Wait-times starting from diagnosis of cataracts until surgery
arm group label: Intervention Site-LAC+USC Medical Center
arm group type: Experimental
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 group label: Control Site--Harbor-UCLA Medical Center
arm group type: No Intervention
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: No Pre-Op Testing for Cataract Surgeries
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.
arm group label: Intervention Site-LAC+USC Medical Center
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine A. Sarkisian, MD, MSHS
role: Principal Investigator
affiliation: University of California, Los Angeles
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Catherine A. Sarkisian
investigator title: Professor
mesh term: Cataract