UCLA Health Department of Medicine
Los Angeles, California, 90095, United States
NCT Number: NCT07671976
This is a prospective randomized controlled trial evaluating an EHR-embedded behavioral intervention intended to reduce low-value specialty referrals in cardiology, pulmonology, and gastroenterology. The intervention is designed to (1) strengthen physicians' intentions to avoid low-value specialty referrals at the point of encounter by presenting criteria for high-value referrals and informing physicians that referral decisions may be reviewed and (2) support follow-through on these intentions by modifying the referral process through structured checklist prompts embedded within the referral workflow.
The primary hypothesis is that physicians exposed to the intervention will demonstrate lower rates of low-value cardiology, pulmonology, and gastroenterology referrals compared with physicians exposed to the arm where the order composer allows physicians to place referrals with minimal decision support.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90095, United States
Low-value care-services that provide little or no clinical benefit-is a significant problem in the United States. For example, low-value specialty referrals often lead to unnecessary tests, follow-ups, and procedures that burden patients, weaken trust, and reduce access to specialty care for those with greater clinical need.
This study is a six-month, single-site, randomized controlled trial conducted at UCLA Health to evaluate an electronic health record (EHR)-embedded behavioral intervention designed to reduce low-value specialty referrals in cardiology, pulmonology, and gastroenterology. The study focuses on physician decision-making at the point of referral and tests whether structured, real-time decision support can reduce low-value care while maintaining patient safety and access to appropriate specialty services.
The study employs a parallel-arm, randomized design. Physicians are randomized to one of three study arms and will remain in their assigned condition throughout the six-month intervention period. The intervention is delivered automatically within routine clinical workflow.
The target study population consists of actively practicing UCLA Health physicians who have placed at least one specialty referral to cardiology, pulmonology, or gastroenterology within six months during the baseline period. Randomization will be conducted by the study team prior to trial initiation using a computerized procedure. The study team will generate 100,000 candidate random allocations of providers to one of three study arms in approximately equal proportions. For each candidate allocation, we assess balance across the following five metrics derived from the baseline period: referral volume to each of the three target specialties (cardiology, GI, and pulmonology) during the baseline period, assessed separately for each specialty (using ANOVA F-test p-values); physician's modal target specialty (using chi-square p-values); physician's department group (using chi-square p-values). The top 1% of allocations achieving the best simultaneous balance across all five metrics (maximin criterion) are retained, and the final allocation is selected at random from this set.
This study does not employ traditional blinding. Physician participants are aware of the content of the order panel they encounter, as the intervention is delivered through their routine EHR workflow. However, physicians are not informed that they are participating in a research study prior to the trial, to avoid influencing referral behavior. The research team conducting outcome analyses does not interact with participants and outcomes are derived from objective EHR data, minimizing the risk of ascertainment bias.
Analysis Plan:
Primary Analyses: The investigators will estimate intent-to-treat effects using ordinary least squares (OLS) regressions models with heteroskedasticity-robust standard errors to predict outcome variables. All analyses will be conducted at the physician level.
As robustness checks, the investigators will estimate specifications that weight observations by the number of referral-relevant encounters.
Cardiology
Hyperlipidemia - General Cardiology referral - low-value if criterion is unmet:
Hyperlipidemia - Lipid Clinic referral - low-value if no criterion is met:
Hypertension - low-value if neither criterion is met:
Pulmonology
Cough - low-value if neither criterion is met:
Asthma - low-value if no criterion is met:
COPD - low-value if no criterion is met:
Lung Nodule - low-value if referral is placed for incidentally detected nodule and no criterion is met:
Gastroenterology
GERD - low-value if neither criterion is met:
Constipation - low-value if neither criterion is met:
Acute Diarrhea (<14 days) - low-value if no red flag criterion is met:
Chronic Diarrhea (>14 days) - low-value if criterion is unmet:
Secondary Analyses:
The investigators will conduct secondary analyses to better understand the mechanisms through which the interventions operate: (a) comparing Arm 2 vs. Arm 1 to assess the effect of highlighting referral criteria and the likelihood of being reviewed, and (b) comparing Arm 3 vs. Arm 2 to assess the effect of prompting deliberation with a checklist, using the same modeling approach as the primary analysis.
In addition, the investigators will analyze measures related to the hypothesized mechanisms (referral knowledge, perceived accountability, and perceived procedural frictions) using physician post-RCT survey measures. These analyses will examine whether physicians' referral knowledge, perceptions, and experiences are associated with referral behavior, and whether patterns across arms are consistent with the hypothesized mechanisms. Each mediator will be operationalized from the post-RCT survey as follows:
These analyses will be conducted as follows:
The investigators will also conduct exploratory analyses examining whether the effect of Arm 3 (vs. Arm 1) varies by baseline pre-RCT survey measures of referral knowledge, perceived accountability, and perceived procedural friction. For each of these baseline survey measures, the investigators will estimate an OLS regression to predict the primary dependent variable on assignment to Arm 3 (vs. Arm 1), the baseline measure, their interactions, and control variables mentioned above. These analyses will assess whether physicians with lower baseline knowledge, lower perceived accountability, or lower baseline tendency to consider referral appropriateness show larger treatment responses.
Heterogeneity Analyses:
Although physicians are the enrolled study participants and the primary unit of analysis, the intervention may affect referral behavior differently depending on patient characteristics. We will therefore conduct pre-specified heterogeneity analyses by patient gender, race/ethnicity, and insurance type. Specifically, we will estimate treatment effects separately for patients who are female versus male, non-Hispanic White versus all other race/ethnicity categories combined, and insurance type (Traditional Medicare, Medicare Advantage, Medicaid, Commercial, other/unknown; if we can receive more detailed insurance information to further differentiate commercial plan types-e.g., PPO vs. HMO-we will compare major commercial plan types).
For each patient subgroup of interest, the investigators will compute physician-level rates of low-value referrals restricted to referral-relevant encounters involving patients in that subgroup (e.g., separate rates for encounters involving female versus male patients). Each physician will then have multiple observations, capturing outcomes for different patient subgroups. The investigators will estimate a single regression model that includes the patient subgroup indicator, physician's treatment assignment indicator, and their interaction, with standard errors clustered at the physician level. The interaction term tests whether the treatment effect on low-value referral rates differs across patient subgroups.
Per funder requirements, the investigators will check whether the effects differ by physician gender and race/ethnicity, though no significant differences are expected.
Missing Data: The investigators will handle missing data as follows. Missing covariates will be handled with mean imputation and missing indicators. Missing or undefined physician-level outcomes may arise if a physician does not have referral-relevant encounters during the intervention period.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The order composer displays high-value criteria developed by UCLA Health using professional society guidelines and expert consensus from clinical leadership.
The order composer notifies physicians that their referral decisions may be subject to review.
The order composer includes cascading checkboxes that prompt physicians to confirm that referral criteria are met before submitting a referral. Physicians must actively indicate whether the patient meets referral criteria before submitting a referral. Physicians who determine that a referral remains clinically appropriate despite the patient not meeting listed criteria may select an option indicating that none of the listed criteria apply and provide a brief free-text explanation for proceeding with the referral.
Time frame: During 6-month intervention period
A low-value referral is defined as a referral to one of the three target specialty divisions placed during a referral-relevant encounter that does not meet the pre-specified referral criteria developed by UCLA Health division chiefs for the corresponding medical condition.
The primary outcome is calculated as the number of low-value referrals divided by the number of referral-relevant encounters, multiplied by 100, aggregated at the physician level.
Time frame: During 6-month intervention period
Number of referrals to the targeted specialty divisions per 100 referral-relevant encounters.
Time frame: During 6-month intervention period
Number of referrals meeting pre-specified high-value criteria to the targeted specialty divisions per 100 referral-relevant encounters.
Time frame: During 6-month intervention period
Number of unplanned hospital admissions occurring within 30 days of a referral-relevant encounter per 100 referral-relevant encounters.
Time frame: During 6-month intervention period
Number of emergency department visits occurring within 30 days of a referral-relevant encounter per 100 referral-relevant encounters.
Time frame: During 6-month intervention period
Number of deaths from any cause occurring within 30 days of a referral-relevant encounter per 100 referral-relevant encounters.
University of California, Los Angeles
Other
Reducing Low-Value Care: Applying the Intention-Action Framework to Specialty Referrals
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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