Utilizing Helpline for Opioid Dependence Treatment

• Conditions: Opioid Dependence
• Interventions: Behavioral: Helpline

• Registration Number: NCT03969238
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-31
• Study Start: 2019-06-25
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-25
• Last Update Posted: 2020-10-28
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients/Providers	Helpline	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.

Primary Outcome Measures

Name	Time	Method
Participant Opioid Helpline Survey	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.
Provider Opioid Helpline Survey	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.

Secondary Outcome Measures

Name	Time	Method
Referral follow-ups	up to a year	Assess which referrals were followed up on by the participants.
Number of participants who continued to access the services of Helpline	up to a year	The investigator will measure the number of participants who continued to access the services of Helpline up to a year.
Number of participants reached versus called.	up to a year	Total number of contacts to the Helpline compared to the number that prescreened and the number consented.
New General Self-Efficacy Measure	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.
Opioid Helpline Study Screen Form	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.

Trial Locations

Locations (1)

UVA Center for Leading Edge Addiction Research; 🇺🇸 Charlottesville, Virginia, United States