- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06527040
Aide à la décision clinique pour la sécurité des transitions aux opioïdes
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Heather Tolle, PhD
- Numéro de téléphone: 303-724-9924
- E-mail: heather.tolle@cuanschutz.edu
Lieux d'étude
-
-
Colorado
-
Aurora, Colorado, États-Unis, 80045
- UCHealth
-
Contact:
- Heather Tolle
- Numéro de téléphone: 502-418-7065
- E-mail: heather.tolle@cuanschutz.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of encounters with an opioid transitioning prescription
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical decision support (CDS) acceptance rate
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jason Hoppe, DO, University of Colorado, Denver
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 24-1192
- R61DA057610 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.
Délai de partage IPD
Data will be provided to NAHDAP after study results are published in peer-reviewed journals.
Critères d'accès au partage IPD
Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .