- ICH GCP
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- Klinische proef NCT06271668
Klinische beslissingsondersteuning om het gelijktijdig voorschrijven van naloxon te verbeteren
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) system.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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]
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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinical decision support (CDS) acceptance rate
Tijdsspanne: 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
|
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Subsequent opioid overdose/poisonings rates
Tijdsspanne: Six months after an encounter where the naloxone clinical decision support fired for the provider
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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
|
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Naloxone dispensed rate
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jason A Hoppe, DO, University of Colorado, Denver
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 23-2356
- R61DA057610 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.
IPD-tijdsbestek voor delen
Data will be provided to NAHDAP after study results are published in peer-reviewed journals.
IPD-toegangscriteria voor delen
Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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