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

University of Washington

Status: Unknown

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

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04275258

1 R49CE003087-01-00 (Other Grant/Funding Number)

STUDY00008440

Details and patient eligibility

About

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.

Full description

This study explores the feasibility, efficacy, and potential sustainability of a collaborative pain care/opioid taper strategy for patients discharged to a rural PCP practice on opioids after hospitalization for moderate to severe traumatic injury.

The randomized control study design will provide important pilot data on the efficacy of opioid taper in the context of engaged pain management care at the PCP level when the PCP is supported by expert consultation and has broad implications for patient and clinician education.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Less than 18 years old
2. Injury Severity Score less than 9
3. Patient is in judicial custody
4. Resident of a state other than Washington
5. Will not be discharged to a rural zip code outside of king county.
6. 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).
7. Currently in cancer treatment or enrolled in palliative or hospice care
8. Residing in a nursing home or assisted living facility
9. Using any implanted device for pain control
10. Self-report of heroin or other illicit opioid use in the past month
11. Psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year (including current admission).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

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

Control group

No Intervention group

Description:

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.