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Predikce strojového učení a snížení předávkování EHR NUDGES (mPROVEN)

2. října 2026 aktualizováno: Walid Gellad, University of Pittsburgh

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.

Přehled studie

Detailní popis

In response to the opioid overdose crisis, health systems have instituted multiple interventions to reduce patient risk, including decreasing unsafe opioid prescribing among high-risk patients and dispensing naloxone. However, these interventions face two key challenges. First, there are limited and poorly performing tools to identify who is truly at risk of overdose, leading to burdensome interventions targeting an overly broad population or missing key high-risk individuals. Second, even with more accurate identification of high-risk patients, highly effective strategies to change clinician behavior remain limited. Common cognitive biases may underlie clinicians' lack of response to risk factors for overdose.

This project aims to address both of these limitations by combining more accurate risk prediction tools to identify those at elevated risk of opioid overdose with novel "nudge" interventions based on principles of behavioral economics that have been shown to address cognitive biases and change prescribing behavior. The primary hypothesis is that high-risk patients in primary care practices randomized to the elevated-risk flag + nudge intervention will have safer prescribing compared to usual care.

Typ studie

Intervenční

Zápis (Odhadovaný)

1350

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Spojené státy, 15213
        • University of Pittsburgh

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Diagnosis of malignant cancer within the past year
  • Enrollment in hospice care

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Usual Care

Patients in the practices randomized to the Usual Care arm will receive standard care practice without change.

Patients in the practices randomized to the Usual Care arm will receive standard care practice without change.

Experimentální: EHR-Embedded Elevated-Risk Flag

An elevated-risk flag will be embedded in the EHR and prominently displayed in the chart during encounters for patients identified as having elevated-risk for opioid overdose.

Clinicians 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.

Experimentální: EHR-Embedded Elevated-Risk Flag with Behavioral Nudges

An elevated-risk flag will be embedded in the EHR and prominently displayed in the chart during encounters for patients identified as having elevated-risk for opioid overdose. This flag will be combined with a set of best practice alerts/behavioral nudges that will trigger when certain conditions are met during encounters with elevated-risk patients.

Clinicians 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.

Ostatní jména:
  • EHR-EMBEDDED ANEPATED-PISK FLAG s nejlepší praxe upozornění (BPAS)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Prescribing Practices Composite Score
Časové okno: 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.)

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.

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.)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Prescribing Practices Composite Score--6 Month Measure
Časové okno: 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.)

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.

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.)
Active Naloxone Prescription
Časové okno: 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.

The presence of an active naloxone prescription, determined by evidence of a naloxone order, a naloxone fill, or both.

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.
Average Daily Opioid Dosage > 50 MME
Časové okno: 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).

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.

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).
Overlapping Opioid Benzodiazepine Prescriptions
Časové okno: 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.

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.

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.
Overlapping Opioid Benzodiazepine Prescriptions Where Average Daily Opioid MME > 50
Časové okno: 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.

This outcome evaluates the presence of overlapping opioid and benzodiazepine use where opioid MME is > 50, defined as above.

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.
Emergency Department or Inpatient Visits
Časové okno: Assessed at 4 and 6 months after study enrollment, based on visits occurring within the 30 days prior to the index date (i.e., 4 and 6 months after enrollment).

This outcome measures the occurrence of any emergency department (ED) or inpatient visit during the specified time period.

Assessed at 4 and 6 months after study enrollment, based on visits occurring within the 30 days prior to the index date (i.e., 4 and 6 months after enrollment).
Emergency Department or Inpatient Visits for Overdose
Časové okno: Assessed at 4 and 6 months after study enrollment, based on visits occurring within the 30 days prior to the index date (i.e., 4 and 6 months after enrollment).

This outcome measures the occurrence of any emergency department (ED) or inpatient visit specifically attributed to an overdose during the specified time period.

Assessed at 4 and 6 months after study enrollment, based on visits occurring within the 30 days prior to the index date (i.e., 4 and 6 months after enrollment).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Walid F Gellad, MD, MPH, University of Pittsburgh Center for Pharmaceutical Policy and Prescribing

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. března 2025

Primární dokončení (Aktuální)

31. května 2026

Dokončení studie (Odhadovaný)

1. května 2027

Termíny zápisu do studia

První předloženo

31. ledna 2025

První předloženo, které splnilo kritéria kontroly kvality

31. ledna 2025

První zveřejněno (Aktuální)

3. února 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

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