Clinical trial NCT03969238: Utilizing Helpline for Opioid Dependence Treatment
Official title: Utilizing Helpline for Opioid Dependence Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Dependence
Keywords: opioid dependence
pain management
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participant Opioid Helpline Survey
timeFrame: up to a year
measure: Provider Opioid Helpline Survey
timeFrame: up to a year
Secondary outcomes:
measure: Number of participants reached versus called.
timeFrame: up to a year
measure: Number of participants who continued to access the services of Helpline
timeFrame: up to a year
measure: New General Self-Efficacy Measure
timeFrame: up to a year
measure: Opioid Helpline Study Screen Form
timeFrame: up to a year
measure: Referral follow-ups
timeFrame: up to a year
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA Center for Leading Edge Addiction Research
state: Virginia
Study officials:
affiliation: University of Virginia
name: Nassima Ait-Daoud Tiouririne, M.D.
role: PRINCIPAL_INVESTIGATOR
References: