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Utilizing Helpline for Opioid Dependence Treatment

25 oktober 2020 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The proposed specific aims are to:

  1. 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
  2. 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.
  3. Test if providers find the opioid helpline helpful and resourceful for their practice and are willing to refer patients to the helpline.

Studietyp

Observationell

Inskrivning (Förväntat)

1000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22903
        • Rekrytering
        • UVA Center for Leading Edge Addiction Research
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

Participant Criteria:

  1. Age greater than or equal to 18 years.
  2. A formal diagnosis of Opioid Use Disorder (OUD) by a health care provider or
  3. If no formal diagnosis of OUD, having a self-reported concern with opioid use or addiction.
  4. An individual seeking to reduce opioid use.
  5. An individual concerned about opioids prescribed for management of new-onset pain or chronic pain.

Provider Criteria:

  1. University of Virginia: Providers of any specialties within VA including dentists that prescribes opioids.
  2. County of Wise: Providers of any specialties including dentists that prescribes opioids.

Exclusion Criteria:

Participant Criteria:

  1. Individuals under 18 years of age.
  2. Individuals seeking treatment for non-opioid substance use disorders
  3. Individuals who have no pain issues
  4. Individuals located outside of Virginia.

Provider Criteria:

Providers outside the designated regions.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Beteende: Helpline
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Participant Opioid Helpline Survey
Tidsram: up to a year
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.
up to a year
Provider Opioid Helpline Survey
Tidsram: up to a year
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.
up to a year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of participants reached versus called.
Tidsram: up to a year
Total number of contacts to the Helpline compared to the number that prescreened and the number consented.
up to a year
Number of participants who continued to access the services of Helpline
Tidsram: up to a year
The investigator will measure the number of participants who continued to access the services of Helpline up to a year.
up to a year
New General Self-Efficacy Measure
Tidsram: 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.
up to a year
Opioid Helpline Study Screen Form
Tidsram: up to a year
This will be use to collect demographic information for individuals who self-identify as needing help or resources from the Helpline.
up to a year
Referral follow-ups
Tidsram: up to a year
Assess which referrals were followed up on by the participants.
up to a year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Virginia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 juni 2019

Primärt slutförande (Förväntat)

1 april 2021

Avslutad studie (Förväntat)

1 april 2021

Studieregistreringsdatum

Först inskickad

27 mars 2019

Först inskickad som uppfyllde QC-kriterierna

28 maj 2019

Första postat (Faktisk)

31 maj 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 oktober 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 oktober 2020

Senast verifierad

1 oktober 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 21376

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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