CataractCW-CATARACTNCT03253874
Pre-Operative Testing for Cataract Surgery Among Adults in LA County
A study testing No Pre-Op Testing for Cataract Surgeries in people with Cataract, run by University of California, Los Angeles.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- No Pre-Op Testing for Cataract Surgeries
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,798 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any DHS patient scheduled for cataract surgery over the 24 month time period
Who cannot join
- DHS patient who are not undergoing cataract surgery over the last 24 months period
About this study
Official title: Evaluation of a Choosing Wisely™ Intervention to Reduce Low Value Pre-Operative Care for Patients Undergoing Cataract Surgery
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.
Read the 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.
.
- Conditions
- Cataract
- Being tested
- No Pre-Op Testing for Cataract Surgeries
- Keywords
- Pre-operative Testing, Cataract Surgery, Health Service Research, Low-Value Care, Safety-Net Hospital
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Pre-Op Testing for Cataract SurgeriesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Site-LAC+USC Medical Center | Experimental | 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. Receives: Behavioral: No Pre-Op Testing for Cataract Surgeries |
| Control Site--Harbor-UCLA Medical Center | No intervention | In this arm or study site, patients will undergo standard of care for cataract surgery without any new guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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.
Measured: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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.
Measured: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
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.
Measured: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
Secondary outcomes (2)
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.
Measured: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
Time to Surgery
Wait-times starting from diagnosis of cataracts until surgery
Measured: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study startOct 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,798 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles County Department of Public Health, LAC+USC Medical Center
- Responsible party
- Principal investigator, Catherine A. Sarkisian, University of California, Los Angeles
- Investigators
- Catherine A. Sarkisian, MD, MSHS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253874
- Sponsor's protocol ID
- UCLA IRB #16-000932
- Acronym
- CW-CATARACT
- Status last verified
- Aug 2017
- First submitted
- 15 Nov 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Choosing Wisely™ Intervention to Reduce Low Value Pre-Operative Care for Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT03253874
- Acronym / sponsor ID
- CW-CATARACT / UCLA IRB #16-000932
- Conditions
- Cataract
- Keywords
- Pre-operative Testing, Cataract Surgery, Health Service Research, Low-Value Care, Safety-Net Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,798 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Los Angeles County Department of Public Health, LAC+USC Medical Center
- Study start
- Oct 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Site-LAC+USC Medical Center | Experimental | Behavioral: No Pre-Op Testing for Cataract SurgeriesIn 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. |
| Control Site--Harbor-UCLA Medical Center | No intervention | –In this arm or study site, patients will undergo standard of care for cataract surgery without any new guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any DHS patient scheduled for cataract surgery over the 24 month time period
Key exclusion criteria (1 listed)
- DHS patient who are not undergoing cataract surgery over the last 24 months period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Pre-Op Testing for Cataract SurgeriesSupported 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. | Behavioural | Intervention Site-LAC+USC Medical Center |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Adverse post-operative events (e.g., arrhythmia, hyperkalemia, etc).
Time frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
Time to Surgery
Time frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine A. Sarkisian, MD, MSHS principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing No Pre-Op Testing for Cataract Surgeries in people with Cataract, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inappropriate pre-operative testing (Clinical Labs) (time frame: 1 year: 6 months prior to guideline implantation & 6 month after guideline implementation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.