Machine-Learning Prediction and Reducing Overdoses With EHR Nudges
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
The goal of this cluster randomized clinical trial is to test a clinician-targeted behavioral nudge intervention in the Electronic Health Record (EHR) for patients who are identified by a machine-learning based risk prediction model as having an elevated risk for an opioid overdose.
The clinical trial will evaluate the effectiveness of providing a flag in the EHR to identify individuals at elevated risk with and without behavioral nudges/best practice alerts (BPAs) as compared to usual care by primary care clinicians.
The primary goals of the study are to improve opioid prescribing safety and reduce overdose risk.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Received an opioid prescription within the past year
Age 18 years or older at the time of the opioid prescription
At least one visit to an internal medicine or family care practice within the past year
Disqualifiers
Diagnosis of malignant cancer within the past year
Enrollment in hospice care
Trial design
Design model
Parallel
Treatments tested in this trial
EHR-Embedded Elevated-Risk Flag
BehavioralClinicians seeing patients at elevated predicted risk will see a flag on the EHR 'storyboard' during in person or telephone encounters indicating the patient is at elevated predicted risk of opioid overdose. The clinician will have the option of including this information into their decision-making process when providing care. There will be no best practice alerts/behavioral nudges in this arm.
EHR-Embedded Elevated-Risk Flag with Behavioral Nudges
BehavioralClinicians seeing patients at elevated predicted risk for opioid overdose will see a flag on the EHR storyboard indicating that the patient is at elevated predicted risk. Clinicians will also receive up to 4 best practice alerts/behavioral nudges during an in-person or telephone primary care encounter with elevated risk patients when certain requirements are met: 1) if the patient does not have an active naloxone prescription on their medication list, the clinicians will receive an active choice alert during any medication ordering to encourage naloxone prescription; 2) if the patient's opioid dosage is \>50 MME, OR they are ordered a new opioid prescription, OR they have an overlapping opioid and benzodiazepine prescription order, the clinicians will receive an accountable justification alert when the relevant order is entered.
Usual Care
BehavioralPatients in the practices randomized to the Usual Care arm will receive standard care practice without change.
Treatment groups
1,350 Participants
are divided into 3 treatment groupsGroup A: Usual CareActive comparator 1 intervention
Group B: EHR-Embedded Elevated-Risk FlagExperimental treatment 1 intervention
Group C: EHR-Embedded Elevated-Risk Flag with Behavioral NudgesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Prescribing Practices Composite Score
This outcome measures a composite of three prescribing practices associated with a reduced risk of opioid overdose. Each of the three is assigned a value of one point, with the composite score ranging from 0 to 3: 1. Naloxone prescription: Evidence of a prescription for naloxone. 2. Opioid dosage \< 50 morphine milligram equivalents (MME) per day: No prescriptions exceeding 50 MME/day during the measurement period. 3. No opioid and benzodiazepine overlap: No concurrent prescriptions for opioids and benzodiazepines. The composite score will be treated as a 3-point ordinal measure reflecting adherence to these prescribing practices.
Time frame
Assessed at 4 months following study enrollment (i.e., at 4 months after the first encounter in the study period. An encounter refers to the 1st primary care visit for a patient enrolled in the study.)Secondary outcomes
1
Prescribing Practices Composite Score--6 Month Measure
This outcome measures a composite of three prescribing practices associated with a reduced risk of opioid overdose. Each of the three is assigned a value of one point, with the composite score ranging from 0 to 3: 1. Naloxone prescription: Evidence of a prescription for naloxone. 2. Opioid dosage \< 50 morphine milligram equivalents (MME) per day: No prescriptions exceeding 50 MME/day during the measurement period. 3. No opioid and benzodiazepine overlap: No concurrent prescriptions for opioids and benzodiazepines. The composite score will be treated as a 3-point ordinal measure reflecting adherence to these prescribing practices.
Time frame
Assessed at 6 months following study enrollment (i.e., at 6 months after the first encounter in the study period. An encounter refers to the 1st primary care visit for a patient enrolled in the study.)2
Active Naloxone Prescription
The presence of an active naloxone prescription, determined by evidence of a naloxone order, a naloxone fill, or both.
Time frame
Assessed at 4 & 6 months after study enrollment by reviewing data from 12 months preceding index date (i.e., at 4 & 6 months after enrollment). An active naloxone prescription is recorded if one exists at any point during the year before the index date.3
Average Daily Opioid Dosage > 50 MME
The average daily opioid dosage, calculated in morphine milligram equivalents (MME), is evaluated using prescription fills data as the primary source. If fills data are unavailable, prescription orders data will be used. This measure reflects whether the average daily MME exceeds 50 during the specified time period.
Time frame
Assessed at 4 and 6 months after study enrollment, based on the average daily MME calculated over the 7 days preceding the index date (i.e., 4 and 6 months after enrollment).4
Overlapping Opioid Benzodiazepine Prescriptions
This outcome evaluates overlapping opioid and benzodiazepine use, determined by the following criteria: (A) Active overlap on the index date: Both an opioid and a benzodiazepine prescription fill are active on the index date. (B) Historical overlap: At least one opioid and one benzodiazepine prescription order within the past 28 days. Overlap is defined as meeting any of the above.
Time frame
Assessed at 4 and 6 months after study enrollment, based on overlap occurring on the index date (i.e., 4 and 6 months after enrollment) or within the 28 days preceding the index date.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov