Clinical trial NCT04104256: Using Behavioral Economics to Reduce Low-Value Care
Official title: Pragmatic Trial of an Electronic Health Record/Behavioral Economics Intervention to Reduce Pre-Operative Testing for Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Operative Testing for Cataract Surgery
Keywords: Low Value Care
Cataract Surgery
Behavioral Economics
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: RAND
name: National Institute on Aging (NIA)
First posted: 2019-09-26
Enrollment: 1045
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 (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:

1. 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"
2. 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.

Eligibility criteria: Inclusion Criteria:

* Patient at UCLA undergoing cataract surgery, and receives pre-operative evaluation at UCLA Health

Exclusion Criteria:

* Cataract surgery patients who get their pre-operative evaluation from non-UCLA physicians

Primary outcomes:
measure: Pre-Operative Testing Change
timeFrame: Pre-intervention (Baseline), Post-Intervention (12 months)
Secondary outcomes:
measure: Pre-Operative Testing Change
timeFrame: Pre-intervention (Baseline), Post-Intervention (12 months)
measure: Pre-Operative Testing Change for Specific Categories of Tests
timeFrame: Pre-intervention (Baseline), Post-Intervention (12 months)
measure: Physician Experience Survey Results
timeFrame: Post-Intervention (12 months)
measure: System-level Change - Surgery Cancellations
timeFrame: Baseline, 12 months
measure: System-level Change - Cost Savings
timeFrame: Pre-intervention (Baseline), Post-Intervention (12 months)
measure: System-level Change - Return on Investment
timeFrame: Pre-intervention (Baseline), Post-Intervention (12 months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Health
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Catherine A Sarkisian, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Keay 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.
citation: Schein 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.
citation: Chen 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.
citation: Schein 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.
citation: Rumball-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.
citation: Meeker 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.
citation: Ahmadi 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.