Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder

NCT04275258 | Unknown DMC

• 3 other identifiers: STUDY000084401 R49CE003087-01-001R49CE003087-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will enroll 100 participants using a randomized control trial design to implement and evaluate an individualized opioid taper program supporting rural Primary Care Physicians (PCPs) caring for patients with moderate to severe trauma discharged on opioids. This study will link a trauma center Physician Assistant (PA) with rural PCPs to facilitate pain care and the individualized opioid taper. The investigators seek to improve patient's pain and opioid outcomes and support the PCPs who assume care for these complex patients after hospital discharge. Our long term goal is to provide a service that will help trauma patients as they go back into primary care and into pain- and opioid-free living.

Conditions

Opioid Use; Pain, Postoperative; Opioid Use, Unspecified; Trauma; Opioid-use Disorder

Outcome Measures

Primary Outcomes (2)

• Primary pain outcome: Pain, Enjoyment, General Activity (PEG)

  Patient reported 0-10 pain severity, enjoyment of life interference, general activity interference total score

  24 weeks

• Primary opioid outcome: percent of patients at or below their pre-trauma opioid daily dose

  Percent of patients at or below pre-trauma opioid dose

  24 weeks

Secondary Outcomes (5)

• PROMIS-29 health status

  24 weeks

• Illicit drug use

  24 weeks

• Problem alcohol use

  24 weeks

• Past-month cannabis use

  24 weeks

• satisfaction with pain care

  24 weeks

Other Outcomes (7)

• Feasibility

  24 weeks

• Sustainability

  24 weeks

• Fidelity

  24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Subjects will receive standard trauma discharge plan and no more than a 2-week supply of opioids. Subjects will complete surveys at baseline, 12-week, and 24-week post hospital discharge. In addition, subjects will receive: * A face-to-face meeting prior to discharge where the PA will discuss with the subject their individualized pain management plan and individualized opioid taper plan. * PA will contact subject on the phone within the first week after hospital discharge to ensure subject plans to follow up with PCP and to troubleshoot any subject concerns related to pain management.

Other: Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan

Control group

NO INTERVENTION

Subjects will receive standard trauma discharge plan and no more than a 2-week supply of opioids. Subjects will complete surveys at baseline, 12-week, and 24-week post hospital discharge.

Interventions

Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan OTHER

PA checks in with PCP at 1,2,4,8, 12, 16, and 20 weeks post hospital discharge by secure e-mail, fax or phone to provide opioid taper and pain management guidance until patient has tapered off opioids or returned to pre-trauma doses. PCP may contact PA whenever needed. If PCP requests assistance or reports deviation from the planned opioid taper, PA will provide individualized consultations, which may include a revised taper plan and/or adjunctive therapy recommendations. If there is continued deviation from the planned taper, the PA will facilitate a UW TelePain multidisciplinary telemedicine consultation. The collaborative pain care and opioid taper intervention ends at 20 weeks.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years old
• Injury Severity Score of 9 or greater
• Resident of Washington state
• Will be discharged to a rural zip code outside of king county.
• Glasgow Coma Score of 15
• Able to read, speak, and write English or Spanish.
• Has an identifiable PCP or willing to accept referral to a local Federally Qualified Health Center (FQHC)
• Has an insurer included in the All Payer Claims Database
• Planned to be discharged on opioid medication
• Planned to be discharged back to the community

You may not qualify if:

• Less than 18 years old
• Injury Severity Score less than 9
• Patient is in judicial custody
• Resident of a state other than Washington
• Will not be discharged to a rural zip code outside of king county.
• Evidence of OUD diagnosis (including using heroin or other illicit opioids in the past month, a DSM-5 OUD diagnosis, or evidence of taking methadone, buprenorphine, or naltrexone).
• Currently in cancer treatment or enrolled in palliative or hospice care
• Residing in a nursing home or assisted living facility
• Using any implanted device for pain control
• Self-report of heroin or other illicit opioid use in the past month
• Psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year (including current admission).

Sponsors & Collaborators

• University of Washington: lead
• Centers for Disease Control and Prevention: collaborator
• Harborview Injury Prevention and Research Center: collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (1)

• Sullivan MD, Katers L, Wang J, Arbabi S, Tauben D, Baldwin LM. A randomized trial of collaborative support for opioid taper after trauma hospitalization. Subst Abuse Treat Prev Policy. 2024 Jun 24;19(1):33. doi: 10.1186/s13011-024-00613-x.

  PMID: 38915106 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Wounds and Injuries; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Mark Sullivan, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrienne James

CONTACT

206-744-4634; ajames1@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The team member that coordinates subject's follow-up survey completion after hospital discharge will be masked. Team members involved with outcome analysis will be masked. .
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Model Details: The investigators will use a randomized controlled trial design. Patients taking opioids prior to trauma are at an increased risk for adverse opioid outcomes, therefore we will stratify randomization so that the intervention and control groups are half opioid exposed and half opioid naïve at the time of trauma, Patients with any prescription opioid use in the 30 days prior to trauma will be considered opioid-exposed, while those with no prescription opioid use in the prior 30 days will be considered opioid naïve.

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 19, 2020
• Study Start: June 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: January 31, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)