Utilizing Helpline for Opioid Dependence Treatment
25 ottobre 2020 aggiornato da: Nassima Ait-Daoud Tiouririne, University of Virginia
The investigator propose to develop an opioid telephone helpline, where trained counselors and educators provide referral, educational and targeted interventions and support to individuals interested in addressing their addiction or needing help with managing their pain.
The proposed application builds on "tobacco quit line" efforts, a nationally-adopted telephone-based service, providing education materials, access to cessation medication and counseling against tobacco use.
Similar to tobacco quit line; the proposed telephone based services will remove barriers to treatment as they help individuals at the exact time of need.
The helpline will also educate individuals with new onset pain about pain expectations, relaxation techniques, use of pharmacology and psychotherapy for treatment in addition to providing support for coping and reducing dependency on prescription opioids.
It will be a low cost, easily accessible and utilizable technology to augment the clinical outcome of medication assisted treatment of opioid use disorder and pain management.
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The proposed specific aims are to:
- Test if the helpline is a resourceful tool for patients with opioid use disorder looking for referrals and support to access treatment. The opioid helpline will provide individuals with opioid use disorder seeking treatment, direct access to a live person who can answer questions regarding referrals and various treatment programs. The helpline will also follow-up on treatment compliance and offer support and motivational techniques for these individuals to stay engaged in treatment
- Test if the helpline is a resourceful tool for patients with new onset of pain or chronic pain being prescribed opioids. The opioid helpline will provide these individuals the necessary educational materials on managing pain safely while avoiding misuse. It will offer free imagery guided meditation and other non-pharmacological tools to help with pain management.
- Test if providers find the opioid helpline helpful and resourceful for their practice and are willing to refer patients to the helpline.
Tipo di studio
Osservativo
Iscrizione (Anticipato)
1000
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22903
- Reclutamento
- UVA Center for Leading Edge Addiction Research
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Contatto:
- Eva Jenkins-Mendoza
- Numero di telefono: (434)243-0562
- Email: emj9c@virginia.edu
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Contatto:
- Tracie Kostelac
- Numero di telefono: 434-243-0563
- Email: tlk5d@virginia.edu
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
We plan to pilot this model in a small rural area with low accessibility to specialized treatment. We will specifically target the area of county of Wise as it is an area with one of the highest rate of opioid addiction and overdose related deaths in the state.
UVA hospital: we plan to pilot this model at UVA hospital because it is a health care system offering care to a diverse population from urban and rural areas.
The providers will be educated regarding the goals and objectives of the helpline: Any specialty physicians, nurses including dentists that prescribes opioids within Virginia They will be asked to have flyers about the helpline in their office and refer patients who are prescribed opioids to get more support from the helpline.
Descrizione
Inclusion Criteria:
Participant Criteria:
- Age greater than or equal to 18 years.
- A formal diagnosis of Opioid Use Disorder (OUD) by a health care provider or
- If no formal diagnosis of OUD, having a self-reported concern with opioid use or addiction.
- An individual seeking to reduce opioid use.
- An individual concerned about opioids prescribed for management of new-onset pain or chronic pain.
Provider Criteria:
- University of Virginia: Providers of any specialties within VA including dentists that prescribes opioids.
- County of Wise: Providers of any specialties including dentists that prescribes opioids.
Exclusion Criteria:
Participant Criteria:
- Individuals under 18 years of age.
- Individuals seeking treatment for non-opioid substance use disorders
- Individuals who have no pain issues
- Individuals located outside of Virginia.
Provider Criteria:
Providers outside the designated regions.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Patients/Providers
Of the1,000 participants: (1) 900 will enroll as participants who use the helpline resources via verbal consent and (2) 100 will enroll as providers via online consent prior to survey data collection.
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This helpline will aim to provide patients with new diagnosis of pain who are prescribed opioids, access to education, support and free behavioral technique to help manage their pain such as mindfulness exercises.
For those with opioid use disorder, the helpline will offer support in the form of education about the disorder, opioid withdrawal symptoms, risks of overdoses, and a variety of services such as help reach appropriate care with MAT licensed providers, information on FDA-approved MAT and naloxone, and, in some cases, behavioral intervention to keep patients engaged in treatment.
The opioid helpline will provide a central resource for direct services and a portal for community services.
It will also serve as a referral resource for health-care professionals.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Participant Opioid Helpline Survey
Lasso di tempo: up to a year
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Primary outcomes measure the rating of the Helpline by the patients.
They will be sent surveys that will ask the patients to rate the services they receive on a scale of 1 to 10, with 1 meaning they are very dissatisfied and 10 meaning they are very satisfied.
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up to a year
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Provider Opioid Helpline Survey
Lasso di tempo: up to a year
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Primary outcomes measure the rating of the Helpline by the providers.
They will be sent surveys that will ask the providers to rate the services they receive on a scale of 1 to 10, with 1 meaning they are very dissatisfied and 10 meaning they are very satisfied.
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up to a year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of participants reached versus called.
Lasso di tempo: up to a year
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Total number of contacts to the Helpline compared to the number that prescreened and the number consented.
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up to a year
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Number of participants who continued to access the services of Helpline
Lasso di tempo: up to a year
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The investigator will measure the number of participants who continued to access the services of Helpline up to a year.
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up to a year
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New General Self-Efficacy Measure
Lasso di tempo: up to a year
|
By using this survey, the investigator will determine the participant's ability to handle the situation that prompted the participant to call the Helpline originally.
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up to a year
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Opioid Helpline Study Screen Form
Lasso di tempo: up to a year
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This will be use to collect demographic information for individuals who self-identify as needing help or resources from the Helpline.
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up to a year
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Referral follow-ups
Lasso di tempo: up to a year
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Assess which referrals were followed up on by the participants.
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up to a year
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
25 giugno 2019
Completamento primario (Anticipato)
1 aprile 2021
Completamento dello studio (Anticipato)
1 aprile 2021
Date di iscrizione allo studio
Primo inviato
27 marzo 2019
Primo inviato che soddisfa i criteri di controllo qualità
28 maggio 2019
Primo Inserito (Effettivo)
31 maggio 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
28 ottobre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 ottobre 2020
Ultimo verificato
1 ottobre 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 21376
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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