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Using Behavioral Economics to Reduce Low-Value Care

Primary Purpose

Pre-Operative Testing for Cataract Surgery

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pre-Operative Testing for Cataract Surgery focused on measuring Low Value Care, Cataract Surgery, Behavioral Economics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Alert 1

Alert 2

Alert 3

Control

Arm Description

Pre-op clinic physicians will be confronted with nudge #1 if they attempt to place an order for a pre-op test during the pre-op encounter.

Pre-op clinic physicians will be confronted with nudge #1 if they attempt to place an order for a pre-op test during the pre-op encounter.

Pre-op clinic physicians will be confronted with nudge #1 if they attempt to place an order for a pre-op test during the pre-op encounter.

Pre-op clinic physicians will not receive interventions and perform duties as usual.

Outcomes

Primary Outcome Measures

Pre-Operative Testing Change
Change in percentage of patients undergoing pre-operative testing (labs, EKG, CXR)

Secondary Outcome Measures

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.
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).
Physician Experience Survey Results
Perceived change in workflow, autonomy, satisfaction (Modified Survey)
System-level Change - Surgery Cancellations
Analysis of day of surgery cancellations
System-level Change - Cost Savings
Analysis of costs saved
System-level Change - Return on Investment
Analysis of cost savings to the health system assuming a reduction of tests being ordered

Full Information

First Posted
September 24, 2019
Last Updated
May 16, 2023
Sponsor
University of California, Los Angeles
Collaborators
RAND, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04104256
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
RAND, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Operative Testing for Cataract Surgery
Keywords
Low Value Care, Cataract Surgery, Behavioral Economics

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alert 1
Arm Type
Experimental
Arm Description
Pre-op clinic physicians will be confronted with nudge #1 if they attempt to place an order for a pre-op test during the pre-op encounter.
Arm Title
Alert 2
Arm Type
Experimental
Arm Description
Pre-op clinic physicians will be confronted with nudge #1 if they attempt to place an order for a pre-op test during the pre-op encounter.
Arm Title
Alert 3
Arm Type
Experimental
Arm Description
Pre-op clinic physicians will be confronted with nudge #1 if they attempt to place an order for a pre-op test during the pre-op encounter.
Arm Title
Control
Arm Type
Experimental
Arm Description
Pre-op clinic physicians will not receive interventions and perform duties as usual.
Intervention Type
Behavioral
Intervention Name(s)
Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op tests
Intervention Description
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"
Intervention Type
Behavioral
Intervention Name(s)
Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op tests
Intervention Description
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"
Intervention Type
Behavioral
Intervention Name(s)
Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op tests
Intervention Description
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"
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Control
Intervention Description
Patients will receive usual care from their physicians.
Primary Outcome Measure Information:
Title
Pre-Operative Testing Change
Description
Change in percentage of patients undergoing pre-operative testing (labs, EKG, CXR)
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Pre-Operative Testing Change
Description
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.
Time Frame
Baseline, 12 month
Title
Pre-Operative Testing Change for Specific Categories of Tests
Description
Change in the percentage of patients who received pre-op labs, pre-op EKGs, and pre-op chest x-rays (CXRs).
Time Frame
Baseline, 12 months
Title
Physician Experience Survey Results
Description
Perceived change in workflow, autonomy, satisfaction (Modified Survey)
Time Frame
12 months
Title
System-level Change - Surgery Cancellations
Description
Analysis of day of surgery cancellations
Time Frame
Baseline, 12 months
Title
System-level Change - Cost Savings
Description
Analysis of costs saved
Time Frame
Baseline, 12 months
Title
System-level Change - Return on Investment
Description
Analysis of cost savings to the health system assuming a reduction of tests being ordered
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine A Sarkisian, MD, MSPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19370681
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.
Results Reference
background
PubMed Identifier
22419323
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.
Results Reference
background
PubMed Identifier
10639542
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.
Results Reference
background
PubMed Identifier
25875258
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.
Results Reference
background
PubMed Identifier
22978526
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.
Results Reference
background
PubMed Identifier
28114561
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.
Results Reference
background
PubMed Identifier
26864410
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.
Results Reference
background
PubMed Identifier
34732478
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.
Results Reference
derived
Links:
URL
http://www.choosingwisely.org/societies/american-academy-of-ophthalmology/
Description
Choosing Wisely®. American Academy of Ophthalmology: Five Things Physicians and Patients Should Question. 2013

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Using Behavioral Economics to Reduce Low-Value Care

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