Clinical trial NCT04275258: Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder
Official title: Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use
Pain, Postoperative
Opioid Use, Unspecified
Trauma
Opioid-use Disorder
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Harborview Injury Prevention and Research Center
First posted: 2020-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Primary pain outcome: Pain, Enjoyment, General Activity (PEG)
timeFrame: 24 weeks
measure: Primary opioid outcome: percent of patients at or below their pre-trauma opioid daily dose
timeFrame: 24 weeks
Secondary outcomes:
measure: PROMIS-29 health status
timeFrame: 24 weeks
measure: Illicit drug use
timeFrame: 24 weeks
measure: Problem alcohol use
timeFrame: 24 weeks
measure: Past-month cannabis use
timeFrame: 24 weeks
measure: satisfaction with pain care
timeFrame: 24 weeks
Other outcomes:
measure: Feasibility
timeFrame: 24 weeks
measure: Sustainability
timeFrame: 24 weeks
measure: Fidelity
timeFrame: 24 weeks
measure: Adoption
timeFrame: 24 weeks
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 24 weeks
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 24 weeks
measure: PCP Feasibility of Intervention Measure (FIM) 4 item measure range 4-20
timeFrame: 24 weeks
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Mark Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References: