- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT06271668
Klinische Entscheidungsunterstützung zur Verbesserung der systemischen Naloxon-Co-Verschreibung
The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Clinical decision support tools help clinicians make treatment decisions based on routinely collected data and offer a promising strategy to implement evidence-based practices for safe and effective pain management. This project will use clinical decision support tools embedded into electronic health records to help healthcare providers make treatment decisions that align with opioid prescribing guidelines from the Centers for Disease Control and Prevention (CDC). The project will also use information from prescription drug monitoring programs, insurance claims, and mortality data to evaluate patient outcomes. This research will evaluate how prescribing practices that align with CDC guidelines affect patient outcomes and whether clinical decision support tools provide an advantage over standard care practices for pain management.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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-
Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) system.
Beschreibung
Inclusion Criteria:
- Patients receiving an opioid prescription at discharge from inpatient/ED or close visit in outpatient settings where the clinical decision support (CDS) is implemented
Exclusion Criteria:
- Patients <12 and >89 year of age
- Cancer diagnosis
- Hospice care/palliative care
- Sickle cell disease diagnosis
- Patients who arrived in error
- Patients who were triaged to obstetrics
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Clinical Decision Support (CDS): Naloxone Alert
Encounters where the naloxone clinical decision support (CDS) alert fired. CDS logic is programmed to fire alert when a provider places and order for a high-risk opioid analgesic prescription to a patient without an active naloxone prescription. High-risk prescription logic to trigger the Naloxone CDS: [(NOT 1 AND (2 AND AT LEAST 1 OF (3, 4, 5, 6))) AND 7 AND NOT 8]
|
Clinical decision support in the form of an EHR-integrated, provider facing alert suggesting (a) the opioid medication order is considered high risk for overdose and (b) to nudge providers to add a naloxone prescription to the opioid prescription to mitigate risk in the event of an overdose. |
|
Usual Care
Control group of contemporary encounters where clinical decision support (CDS) is not active. Usual care. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone
Zeitfenster: 18 months
|
The number of high-risk opioid encounters where a naloxone prescription was written with the opioid divided by the total number of encounters where a high-risk opioid prescription was written. |
18 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Clinical decision support (CDS) acceptance rate
Zeitfenster: 18 months
|
The number of times providers accepted the Clinical decision support (CDS) suggestion and co-prescribed naloxone with a high-risk opioid divided by the total number of times a high-risk opioid prescription triggered the CDS alert. |
18 months
|
|
Subsequent opioid overdose/poisonings rates
Zeitfenster: Six months after an encounter where the naloxone clinical decision support fired for the provider
|
The number of patients who had a diagnosis of opioid overdose or poisoning in the six months following the index visit with a high-risk opioid prescribed. |
Six months after an encounter where the naloxone clinical decision support fired for the provider
|
|
Naloxone dispensed rate
Zeitfenster: In the 3 days after the naloxone prescription is written
|
The number of patients who were dispensed a naloxone prescription divided by the number of naloxone prescriptions written. |
In the 3 days after the naloxone prescription is written
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jason A Hoppe, DO, University of Colorado, Denver
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 23-2356
- R61DA057610 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.
IPD-Sharing-Zeitrahmen
Data will be provided to NAHDAP after study results are published in peer-reviewed journals.
IPD-Sharing-Zugriffskriterien
Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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