Pre-Operative Testing for Cataract SurgeryNCT04104256
Using Behavioral Economics to Reduce Low-Value Care
A study testing Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op tests, Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op tests and Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op tests in people with Pre-Operative Testing for Cataract Surgery, run by University of California, Los Angeles at 1 site in United States.
Trial summary
There is strong consensus - based on robust randomized trial data - that routine pre-operative (pre-op) testing for cataract surgery is inappropriate. Despite these widely endorsed evidence-based recommendations, most seniors undergoing cataract surgery still receive unnecessary blood testing, EKGs, and chest X-rays… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-Operative Testing for Cataract Surgery
- What is being tested?
- Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op tests, Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op tests and Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,045 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2021to 14 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at UCLA undergoing cataract surgery, and receives pre-operative evaluation at UCLA Health
Who cannot join
- Cataract surgery patients who get their pre-operative evaluation from non-UCLA physicians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Trial of an Electronic Health Record/Behavioral Economics Intervention to Reduce Pre-Operative Testing for Cataract Surgery
There is strong consensus - based on robust randomized trial data - that routine pre-operative (pre-op) testing for cataract surgery is inappropriate. Despite these widely endorsed evidence-based recommendations, most seniors undergoing cataract surgery still receive unnecessary blood testing, EKGs, and chest X-rays (CXRs); another substantial percentage even undergo nonindicated cardiac stress tests. We will integrate three new best practice alert (BPA) nudges into the University of California, Los Angeles (UCLA) Health electronic health record (EHR). The nudges are informed by behavioral economic theory and are designed to alter the choice architecture for physicians to decrease the rate of pre-op test ordering while still preserving clinician autonomy. We will conduct a pragmatic trial to evaluate whether these BPA nudges reduce low-value pre-op testing for cataract surgery.
Read the detailed description
There is strong consensus - based on robust randomized trial data - that routine pre-operative (pre-op) testing for cataract surgery is inappropriate (Keay et al, 2009; Keay et al, 2012; Schein et al, 2000; Chen et al, 2015). Because pre-op testing provides no benefit to patients, the American Academy of Ophthalmology named reducing routine pre-op testing for cataract surgery the #1 issue that patients and physicians should question as part of the Choosing Wisely™ campaign (Schein et al, 2012). Despite these widely endorsed evidence-based recommendations, most seniors undergoing cataract surgery still receive unnecessary blood testing, EKGs, and chest X-rays (CXRs); another substantial percentage even undergo non-indicated cardiac stress tests (Rumball-Smith et al, 2017).
With cataract surgery being the most common medical procedure among Medicare beneficiaries (predicted 4.4 million per year by the year 2030) (Schein et al, 2012), widespread reduction of routine pre-op testing for cataract surgery would reduce costs, reduce exposure to unnecessary and potentially harmful tests, and allow millions of seniors to spend more time enjoying life rather than wasting their time receiving inappropriate health care.
The investigators hypothesize that an interdisciplinary electronic health record (EHR)-based intervention that applies behavioral economics approaches (i.e., "nudges") will dramatically reduce pre-op testing for cataract surgery in a real-world clinical setting. The investigators propose to test this hypothesis by conducting a pragmatic randomized trial, implementing this intervention at UCLA Health (Ronald Reagan UCLA Medical Center), where ~3200 cataract surgeries are performed per year. The specific aims are to:
- Integrate three new BPA nudges into the UCLA Health EHR. The investigators will conduct a four-arm randomized pragmatic trial to compare the effectiveness of the nudges vs. usual care. Three distinct nudges were tailored to highlight the safety aspects of pre-op tests, the financial harms to the patient of experiencing pre-op tests, and the potential psychological harms to the patient of experiencing preop tests. The pragmatic trial will include three types of behavioral nudges to promote the desired reduction in low value care: Nudge 1:
- UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
- UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
- Routine pre-op tests are inappropriate.
- Routine pre-op tests do NOT increase patient safety and go AGAINST local and national guidelines
- Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES" Nudge 2:
- UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
- UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
- Routine pre-op tests are inappropriate.
- Routine pre-operative tests can increase the patient's out-of-pocket costs without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines
- Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES" Nudge 3:
- UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
- UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
- Routine pre-op tests are inappropriate.
- Routine pre-operative tests can cause aggravation and psychological stress for the patient without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines
- Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES"
- Randomize providers who conducted a pre-op visit in 2019 and those who are expected to conduct such a visit during the 12-month study period to one of 4 study arms (usual pre-op care, Nudge #1, Nudge #2, or Nudge #3) and measure and compare the efficacy of each intervention. The investigators will measure and compare rates of testing before and after initiation of the randomization. Outcomes will be measured 12-months after the intervention start date.
For the primary outcome, we will assess the change in the percentage of cataract patients who undergo one or more pre-op tests after 12 months, where the baseline comparison will be 2019. While we intended to the 12-month pre-period as the baseline, the COVID-19 pandemic had a substantial impact on cataract surgeries. We will compare the percentage of patients receiving pre-op testing in the pooled nudge arms to the usual care arm (primary outcome) and measure the efficacy of each individual nudge arm to determine whether certain behavioral economic framing techniques are more effective than others at reducing pre-op testing (secondary outcomes). Other secondary outcomes will include the change in the percentage of patients who received pre-op labs, pre-op EKGs, and pre-op CXRs. We will also evaluate the total number of pre-op tests patients received, same-day surgery cancellations, cost savings to the health system, and cost savings to the patient. To elicit the views and experiences of physicians, we will survey physicians randomized to all intervention arms to evaluate their experience with the EHR alerts.
Reducing patient exposure to unnecessary care is central to improving patient outcomes and value. This project is fully aligned with UCLA Health leadership's current priority of supporting cross-departmental system change to improve quality of care, outcomes, and value for UCLA patients. Because of the close partnership between our UCLA Informatics co-Investigators and the EHR vendor (Epic), the low-cost intervention that we propose to implement and test will be easily disseminatable to all Epic-based health systems, and will have the potential to dramatically reduce inappropriate pre-op testing across the nation.
EHRs are in their infancy, and the scientific community is only beginning to learn how to use them as tools to promote desired care processes (Meeker et al, 2016). This proposed pragmatic trial would break new ground in our understanding of how behavioral economics approaches can be used to tamp down on care that does not promote better patient outcomes.
- Being tested
- Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op tests, Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op tests, Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op tests, Usual Care
- Keywords
- Low Value Care, Cataract Surgery, Behavioral Economics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op testsBehavioural
Nudge 1:
- UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
- UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
- Routine pre-op tests are inappropriate.
- Routine pre-op tests do NOT increase patient safety and go AGAINST local and national guidelines Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES"
Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op testsBehavioural
Nudge #2:
- UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
- UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
- Routine pre-op tests are inappropriate.
- Routine pre-operative tests can increase the patient's out-of-pocket costs without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines
- Nudge includes "hard stop" before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES"
Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op testsBehavioural
Nudge 3:
- UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
- UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
- Routine pre-op tests are inappropriate.
- Routine pre-operative tests can cause aggravation and psychological stress for the patient without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines
- Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES"
Usual CareOther
Also called Control
Patients will receive usual care from their physicians.
| Study group | Role | What they receive |
|---|---|---|
| Alert 1 | Experimental | Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #1 group. Receives: Behavioral: Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op tests |
| Alert 2 | Experimental | Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #2 group. Receives: Behavioral: Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op tests |
| Alert 3 | Experimental | Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #3 group. Receives: Behavioral: Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op tests |
| Control | Experimental | Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Control group. Encounter continues as usual. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Operative Testing Change
Change in percentage of patients undergoing pre-operative testing (labs, EKG, CXR)
Measured: Pre-intervention (Baseline), Post-Intervention (12 months)
Secondary outcomes (6)
Pre-Operative Testing Change
Efficacy of each individual nudge arm compared with usual care to determine whether certain behavioral economic framing techniques are more effective than others at reducing pre-op testing.
Measured: Pre-intervention (Baseline), Post-Intervention (12 months)
Pre-Operative Testing Change for Specific Categories of Tests
Change in the percentage of patients who received pre-op labs, pre-op EKGs, and pre-op chest x-rays (CXRs).
Measured: Pre-intervention (Baseline), Post-Intervention (12 months)
Physician Experience Survey Results
Perceived change in workflow, autonomy, satisfaction (Modified Survey)
Measured: Post-Intervention (12 months)
System-level Change - Surgery Cancellations
Analysis of day of surgery cancellations for enrolled participants
Measured: Baseline, 12 months
System-level Change - Cost Savings
Analysis of costs saved for enrolled participants
Measured: Pre-intervention (Baseline), Post-Intervention (12 months)
System-level Change - Return on Investment
Analysis of cost savings to the health system assuming a reduction of tests being ordered
Measured: Pre-intervention (Baseline), Post-Intervention (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start24 Jun 2021
- Primary completion11 Apr 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pre-Operative Testing for Cataract SurgeryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- RAND, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Catherine A. Sarkisian, University of California, Los Angeles
- Investigators
- Catherine A Sarkisian, MD, MSPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104256
- Sponsor's protocol ID
- R01AG059815-01
- Other IDs
- 5R01AG059815
- Status last verified
- Aug 2024
- First submitted
- 24 Sep 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keay L, Lindsley K, Tielsch J, Katz J, Schein O. Routine preoperative medical testing for cataract surgery. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007293. doi: 10.1002/14651858.CD007293.pub2.
PubMed 19370681Keay L, Lindsley K, Tielsch J, Katz J, Schein O. Routine preoperative medical testing for cataract surgery. Cochrane Database Syst Rev. 2012 Mar 14;3(3):CD007293. doi: 10.1002/14651858.CD007293.pub3.
PubMed 22419323Schein OD, Katz J, Bass EB, Tielsch JM, Lubomski LH, Feldman MA, Petty BG, Steinberg EP. The value of routine preoperative medical testing before cataract surgery. Study of Medical Testing for Cataract Surgery. N Engl J Med. 2000 Jan 20;342(3):168-75. doi: 10.1056/NEJM200001203420304.
PubMed 10639542Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA, Dudley RA. Preoperative medical testing in Medicare patients undergoing cataract surgery. N Engl J Med. 2015 Apr 16;372(16):1530-8. doi: 10.1056/NEJMsa1410846.
PubMed 25875258Schein OD, Cassard SD, Tielsch JM, Gower EW. Cataract surgery among Medicare beneficiaries. Ophthalmic Epidemiol. 2012 Oct;19(5):257-64. doi: 10.3109/09286586.2012.698692.
PubMed 22978526Rumball-Smith J, Shekelle PG, Bates DW. Using the Electronic Health Record to Understand and Minimize Overuse. JAMA. 2017 Jan 17;317(3):257-258. doi: 10.1001/jama.2016.18609. No abstract available.
PubMed 28114561Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
PubMed 26864410Ahmadi A, Sorensen A, Villaflores CWA, Mafi JN, Vangala SS, Hofer IS, Bartlett JD, Cheng EM, Duval VF, Damberg C, Elashoff D, Goldstein NJ, Ladapo JA, Moore JM, Pessegueiro AM, Shu SB, Skootsky SA, Turner A, Sarkisian CA. Protocol for pragmatic randomised trial: integrating electronic health record-based behavioural economic 'nudges' into the electronic health record to reduce preoperative testing for patients undergoing cataract surgery. BMJ Open. 2021 Nov 3;11(11):e049568. doi: 10.1136/bmjopen-2021-049568.
PubMed 34732478
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial of an Electronic Health Record/Behavioral Economics Intervention to Reduce Pre-Operative Testing for Cataract Surgery
- ClinicalTrials.gov ID
- NCT04104256
- Acronym / sponsor ID
- R01AG059815-01
- Keywords
- Low Value Care, Cataract Surgery, Behavioral Economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,045 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- RAND, National Institute on Aging (NIA)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is strong consensus - based on robust randomized trial data - that routine pre-operative (pre-op) testing for cataract surgery is inappropriate. Despite these widely endorsed evidence-based recommendations, most seniors undergoing cataract surgery still receive unnecessary blood testing, EKGs, and chest X-rays (CXRs); another substantial percentage even undergo nonindicated cardiac stress tests. We will integrate three new best practice alert (BPA) nudges into the University of California, Los Angeles (UCLA) Health electronic health record (EHR). The nudges are informed by behavioral economic theory and are designed to alter the choice architecture for physicians to decrease the rate of pre-op test ordering while still preserving clinician autonomy. We will conduct a pragmatic trial to evaluate whether these BPA nudges reduce low-value pre-op testing for cataract surgery.
Detailed description
There is strong consensus - based on robust randomized trial data - that routine pre-operative (pre-op) testing for cataract surgery is inappropriate (Keay et al, 2009; Keay et al, 2012; Schein et al, 2000; Chen et al, 2015). Because pre-op testing provides no benefit to patients, the American Academy of Ophthalmology named reducing routine pre-op testing for cataract surgery the #1 issue that patients and physicians should question as part of the Choosing Wisely™ campaign (Schein et al, 2012). Despite these widely endorsed evidence-based recommendations, most seniors undergoing cataract surgery still receive unnecessary blood testing, EKGs, and chest X-rays (CXRs); another substantial percentage even undergo non-indicated cardiac stress tests (Rumball-Smith et al, 2017).
With cataract surgery being the most common medical procedure among Medicare beneficiaries (predicted 4.4 million per year by the year 2030) (Schein et al, 2012), widespread reduction of routine pre-op testing for cataract surgery would reduce costs, reduce exposure to unnecessary and potentially harmful tests, and allow millions of seniors to spend more time enjoying life rather than wasting their time receiving inappropriate health care.
The investigators hypothesize that an interdisciplinary electronic health record (EHR)-based intervention that applies behavioral economics approaches (i.e., "nudges") will dramatically reduce pre-op testing for cataract surgery in a real-world clinical setting. The investigators propose to test this hypothesis by conducting a pragmatic randomized trial, implementing this intervention at UCLA Health (Ronald Reagan UCLA Medical Center), where ~3200 cataract surgeries are performed per year. The specific aims are to:
- Integrate three new BPA nudges into the UCLA Health EHR. The investigators will conduct a four-arm randomized pragmatic trial to compare the effectiveness of the nudges vs. usual care. Three distinct nudges were tailored to highlight the safety aspects of pre-op tests, the financial harms to the patient of experiencing pre-op tests, and the potential psychological harms to the patient of experiencing preop tests. The pragmatic trial will include three types of behavioral nudges to promote the desired reduction in low value care: Nudge 1:
- UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
- UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
- Routine pre-op tests are inappropriate.
- Routine pre-op tests do NOT increase patient safety and go AGAINST local and national guidelines
- Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES" Nudge 2:
- UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
- UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
- Routine pre-op tests are inappropriate.
- Routine pre-operative tests can increase the patient's out-of-pocket costs without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines
- Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES" Nudge 3:
- UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
- UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
- Routine pre-op tests are inappropriate.
- Routine pre-operative tests can cause aggravation and psychological stress for the patient without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines
- Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES"
- Randomize providers who conducted a pre-op visit in 2019 and those who are expected to conduct such a visit during the 12-month study period to one of 4 study arms (usual pre-op care, Nudge #1, Nudge #2, or Nudge #3) and measure and compare the efficacy of each intervention. The investigators will measure and compare rates of testing before and after initiation of the randomization. Outcomes will be measured 12-months after the intervention start date.
For the primary outcome, we will assess the change in the percentage of cataract patients who undergo one or more pre-op tests after 12 months, where the baseline comparison will be 2019. While we intended to the 12-month pre-period as the baseline, the COVID-19 pandemic had a substantial impact on cataract surgeries. We will compare the percentage of patients receiving pre-op testing in the pooled nudge arms to the usual care arm (primary outcome) and measure the efficacy of each individual nudge arm to determine whether certain behavioral economic framing techniques are more effective than others at reducing pre-op testing (secondary outcomes). Other secondary outcomes will include the change in the percentage of patients who received pre-op labs, pre-op EKGs, and pre-op CXRs. We will also evaluate the total number of pre-op tests patients received, same-day surgery cancellations, cost savings to the health system, and cost savings to the patient. To elicit the views and experiences of physicians, we will survey physicians randomized to all intervention arms to evaluate their experience with the EHR alerts.
Reducing patient exposure to unnecessary care is central to improving patient outcomes and value. This project is fully aligned with UCLA Health leadership's current priority of supporting cross-departmental system change to improve quality of care, outcomes, and value for UCLA patients. Because of the close partnership between our UCLA Informatics co-Investigators and the EHR vendor (Epic), the low-cost intervention that we propose to implement and test will be easily disseminatable to all Epic-based health systems, and will have the potential to dramatically reduce inappropriate pre-op testing across the nation.
EHRs are in their infancy, and the scientific community is only beginning to learn how to use them as tools to promote desired care processes (Meeker et al, 2016). This proposed pragmatic trial would break new ground in our understanding of how behavioral economics approaches can be used to tamp down on care that does not promote better patient outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alert 1 | Experimental | Behavioral: Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op testsPatients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #1 group. |
| Alert 2 | Experimental | Behavioral: Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op testsPatients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #2 group. |
| Alert 3 | Experimental | Behavioral: Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op testsPatients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #3 group. |
| Control | Experimental | Other: Usual CarePatients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Control group. Encounter continues as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient at UCLA undergoing cataract surgery, and receives pre-operative evaluation at UCLA Health
Key exclusion criteria (1 listed)
- Cataract surgery patients who get their pre-operative evaluation from non-UCLA physicians
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 |
|---|---|---|
| Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op testsNudge 1: * UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing. * UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery. * Routine pre-op tests are inappropriate. * Routine pre-op tests do NOT increase patient safety and go AGAINST local and national guidelines Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES" | Behavioural | Alert 1 |
| Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op testsNudge #2: * UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing. * UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery. * Routine pre-op tests are inappropriate. * Routine pre-operative tests can increase the patient's out-of-pocket costs without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines * Nudge includes "hard stop" before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES" | Behavioural | Alert 2 |
| Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op testsNudge 3: * UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing. * UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery. * Routine pre-op tests are inappropriate. * Routine pre-operative tests can cause aggravation and psychological stress for the patient without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines * Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES" | Behavioural | Alert 3 |
| Usual CareAlso: ControlPatients will receive usual care from their physicians. | Other | Control |
Primary outcome
Pre-Operative Testing Change
Time frame: Pre-intervention (Baseline), Post-Intervention (12 months)
Change in percentage of patients undergoing pre-operative testing (labs, EKG, CXR)
6 secondary outcomes
Pre-Operative Testing Change
Time frame: Pre-intervention (Baseline), Post-Intervention (12 months)
Pre-Operative Testing Change for Specific Categories of Tests
Time frame: Pre-intervention (Baseline), Post-Intervention (12 months)
Physician Experience Survey Results
Time frame: Post-Intervention (12 months)
System-level Change - Surgery Cancellations
Time frame: Baseline, 12 months
System-level Change - Cost Savings
Time frame: Pre-intervention (Baseline), Post-Intervention (12 months)
System-level Change - Return on Investment
Time frame: Pre-intervention (Baseline), Post-Intervention (12 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19370681Keay L, Lindsley K, Tielsch J, Katz J, Schein O. Routine preoperative medical testing for cataract surgery. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007293. doi: 10.1002/14651858.CD007293.pub2.
- Background: PubMed 22419323Keay L, Lindsley K, Tielsch J, Katz J, Schein O. Routine preoperative medical testing for cataract surgery. Cochrane Database Syst Rev. 2012 Mar 14;3(3):CD007293. doi: 10.1002/14651858.CD007293.pub3.
- Background: PubMed 10639542Schein OD, Katz J, Bass EB, Tielsch JM, Lubomski LH, Feldman MA, Petty BG, Steinberg EP. The value of routine preoperative medical testing before cataract surgery. Study of Medical Testing for Cataract Surgery. N Engl J Med. 2000 Jan 20;342(3):168-75. doi: 10.1056/NEJM200001203420304.
- Background: PubMed 25875258Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA, Dudley RA. Preoperative medical testing in Medicare patients undergoing cataract surgery. N Engl J Med. 2015 Apr 16;372(16):1530-8. doi: 10.1056/NEJMsa1410846.
- Background: PubMed 22978526Schein OD, Cassard SD, Tielsch JM, Gower EW. Cataract surgery among Medicare beneficiaries. Ophthalmic Epidemiol. 2012 Oct;19(5):257-64. doi: 10.3109/09286586.2012.698692.
- Background: PubMed 28114561Rumball-Smith J, Shekelle PG, Bates DW. Using the Electronic Health Record to Understand and Minimize Overuse. JAMA. 2017 Jan 17;317(3):257-258. doi: 10.1001/jama.2016.18609. No abstract available.
- Background: PubMed 26864410Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
- Derived from this study: PubMed 34732478Ahmadi A, Sorensen A, Villaflores CWA, Mafi JN, Vangala SS, Hofer IS, Bartlett JD, Cheng EM, Duval VF, Damberg C, Elashoff D, Goldstein NJ, Ladapo JA, Moore JM, Pessegueiro AM, Shu SB, Skootsky SA, Turner A, Sarkisian CA. Protocol for pragmatic randomised trial: integrating electronic health record-based behavioural economic 'nudges' into the electronic health record to reduce preoperative testing for patients undergoing cataract surgery. BMJ Open. 2021 Nov 3;11(11):e049568. doi: 10.1136/bmjopen-2021-049568.
- Choosing Wisely®. American Academy of Ophthalmology: Five Things Physicians and Patients Should Question. 2013Link provided by the sponsor.
- Individual participant dataSharing planned: No
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, MSPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op tests, Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op tests and Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op tests in people with Pre-Operative Testing for Cataract Surgery, run by University of California, Los Angeles at 1 site in United States.
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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre-Operative Testing Change (time frame: Pre-intervention (Baseline), Post-Intervention (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04104256, which also lists 8 linked publications.
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 19 Sep 2024.