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- Register voor klinische proeven in de VS.
- Klinische proef NCT06592378
Opioïdenbeheer voor ontslagen patiënten op de spoedeisende hulp
Integratie van een platform voor de verstrekking, monitoring en verwijdering van opioïden met een ziekenhuisapotheek om het gebruik van opioïden door ontslagen patiënten op de spoedeisende hulp terug te dringen
The goal of this study is to analyze the use of the Addinex system for opioid dispensing after ambulatory care to determine whether it will reduce opioid consumption, increase pill disposal, show variables that may predict opioid consumption, and determine whether this intervention is acceptable to patients.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Prescription opioids remain a popular drug class with 143 million (M) opioid prescriptions written in 2020. In that same year, 8.7 million people (2.6% of the US population) misused prescription pain relievers, and overdose deaths from opioids continue to rise to 83,695 in 2022. Across six studies, 67% to 92% of patients prescribed opioids reported unused pills. In 2017, patients were prescribed 3.3 billion excess pills, yet no more than 9% of patients properly disposed of their unused opioids. Despite attempts to reduce overprescribing, increase disposal, and decrease diversion, these issues still contribute to increasing misuse, addiction, and overdose deaths.
Addinex Technologies has developed a novel system to reduce the use of opioids through controlling, monitoring, and disposing of excess opioids. The unique "closed-loop" system starts with clinicians prescribing opioids with the Addinex system. Addinex's partner pharmacy then fills the patented dispenser and delivers it to the patient. The patient uses the Addinex app to access each individual dose code and to obtain education and feedback. Finally, the patient returns the dispenser with any excess pills in a DEA-approved mailer to Addinex's partner disposal company. In a study with Columbia University Medical Center using the Addinex system with 30 post-surgical cancer patients, results showed 70% fewer pills used than prescribed, 60% fewer refills for the same surgeries, and an 84% excess pill disposal rate.
Addinex is now partnering with Brown Emergency Medicine and Rhode Island Hospital ("Brown") to perform a feasibility study using Addinex's system. We will conduct a clinical trial involving 100 patients with extremity fractures treated by the emergency department. Half the patients (25 adults and 25 minors) will utilize the Addinex system, while the other half will have their opioids dispensed in a standard pill bottle as the control group. Addinex's system promotes the return of medication using a pre-paid disposal mailer once patients have completed their course of treatment. The clinical study's main goals involve evaluating the system's effectiveness with patients obtaining same day treatment. This evaluation will encompass an analysis of medication consumption, disposal rates, pain levels, the impact of monitoring policies, and ensuring that the established commercial protocols function seamlessly. Ultimately, the project aims to demonstrate that the Addinex system can successfully operate within the broader hospital environment (same day and scheduled procedures), controlling and monitoring opioid usage, promoting patient well-being, and lowering costs.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02903
- Rhode Island Hospital/Lifespan
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Ages six years and older
- Ability to swallow pills
- Isolated bone fracture
- Planned to receive opioids in the post-treatment period
- Not taking opioids daily prior to the procedure
- English or Spanish-speaking
- Able to give informed consent or a parent that can give informed consent
- Ownership of and comfort using apps on a smartphone with compatible operating system
- WIFI or cellular access
- Patient not admitted to hospital
Exclusion Criteria:
- Recent opioid use (last 30 days or 2 or more prescriptions in the past 3 months
- Impaired decisional capacity
- In police custody
- Ward of the state
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Control Adult
Patients in this arm will be adults who undergo standard at-home acute pain management with opioids after treatment for isolated bone fracture (n=25) |
Access and use of opioids in a standard pill bottle. |
|
Actieve vergelijker: Control Child
Patients in this arm will be children who undergo standard at-home acute pain management with opioids after treatment for isolated bone fracture (n=25) |
Access and use of opioids in a standard pill bottle. |
|
Experimenteel: Device Adult
Patients in this arm will be adults who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25) |
Medication dispensing system to control and monitor opioid use |
|
Experimenteel: Device Child
Patients in this arm will be children who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25) |
Medication dispensing system to control and monitor opioid use |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Median pill consumption
Tijdsspanne: One month post treatment
|
Patients are expected to consume at least 16% fewer pills/MMEs using the Addinex system as compared to the control group. |
One month post treatment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Median disposal of opioids
Tijdsspanne: 12 months post treatment
|
Patients are expected to dispose of at least 50% of excess opioid pills using the Addinex system vs. 20% in the control group. |
12 months post treatment
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
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
- 1R43DA060717-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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