- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06527040
Klinisk beslutningsstøtte for sikkerhet ved opioidoverganger
The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert designed to notify providers when an opioid prescription will result in a patient transitioning into a new phase of opioid therapy. The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain recommends that providers reassess patient pain, treatment goals, and the risks and benefits of opioid therapy before patients transition from acute to subacute treatment (1 month of opioid analgesics) and from subacute to chronic opioid treatment (3 months). This study will evaluate a CDS tool that identifies patients who will be transitioning between phases of opioid therapy as a result of a prescribed opioid medication and prompts providers to review patient needs and goals of care. A pre-post study design will be used to compare provider prescribing practices and patient outcomes before and after implementation of the CDS alert. During the pre-implementation period, providers will continue routine care and will have access to existing patient pain assessments and clinical information, but no transition alert will be displayed. During the post-implementation period, providers will receive a notification when an opioid prescription results in a transition to a new phase of therapy and will be encouraged to review patient needs, reassess pain and treatment goals, and document their clinical decision-making. Opioid transition orders, provider documentation, and patient outcomes will be evaluated using medical record data collected during routine clinical care and compared between the pre-implementation and post-implementation periods.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Heather Tolle, PhD
- Telefonnummer: 303-724-9924
- E-post: heather.tolle@cuanschutz.edu
Studiesteder
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-
Colorado
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Aurora, Colorado, Forente stater, 80045
- UCHealth
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Ta kontakt med:
- Heather Tolle
- Telefonnummer: 502-418-7065
- E-post: heather.tolle@cuanschutz.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) primary care system and receive an opioid prescription.
Beskrivelse
Inclusion Criteria: Any primary care encounter where an opioid is prescribed that transitions the patient to a different stage of opioid therapy (acute to subacute after 1 month of opioids; subacute to chronic after 3 months of an opioid)
Exclusion Criteria:
- Patients <12 and >89
- Patients with active cancer diagnosis in last 1 year
- Patients with hospice care/palliative care order
- Patients with sickle cell disease diagnosis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
pre-implementation period
Encounters with a high risk opioid prescription prior to intervention implementation. Providers will not see any alert. Usual care. |
|
|
Clinical Decision Support (CDS): Opioid transition alert
Encounters where the opioid transition clinical decision support (CDS) alert fired. CDS logic is programmed to fire the alert when a provider places an order for an opioid that will transition the patient from acute to subacute opioid therapy (at 30 days) or from subacute to chronic opioid therapy (at 90 days). |
Clinical decision support in the form of an electronic health record (EHR) integrated, provider-facing alert suggesting (a) the patient is transitioning to a new phase of opioid therapy and (b) the provider should review patient pain data and pain management goals as suggested by Center for Disease Control and Prevention (CDC) guidelines. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of encounters with an opioid transitioning prescription
Tidsramme: 18 months
|
The number of primary care encounters where an opioid prescription transitions a patient to a different phase of care (by phase) divided by the total number of opioid prescriptions |
18 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical decision support (CDS) acceptance rate
Tidsramme: 18 months
|
The number of times providers accepted the Clinical decision support (CDS) tool and documented a review of patient pain and goals |
18 months
|
|
Subsequent opioid overdose/poisoning rates
Tidsramme: Six months after an encounter where the opioid use disorder is identified
|
The number of patients who reached the threshold of chronic opioid use, had a diagnosis of opioid overdose/poisoning or a new diagnosis of opioid use disorder |
Six months after an encounter where the opioid use disorder is identified
|
|
Opioid prescription abandonment
Tidsramme: 18 months
|
The proportion of opioid prescriptions initiated (triggering the CDS) and an opioid was not signed by the provider, indicating a change in clinical decision to prescribe an opioid |
18 months
|
|
Number of patients with long term opioid use
Tidsramme: Six months after an encounter where the opioid use disorder is identified
|
Count of patients receiving >90 day supply of opioids |
Six months after an encounter where the opioid use disorder is identified
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jason Hoppe, DO, University of Colorado, Denver
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 24-1192
- R61DA057610 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.
IPD-delingstidsramme
Data will be provided to NAHDAP after study results are published in peer-reviewed journals.
Tilgangskriterier for IPD-deling
Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
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