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

Not Applicable

• Conditions: Opioid-use Disorder; Opioid Use; Pain, Postoperative; Trauma; Opioid Use, Unspecified
• Interventions: Other: Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan

• Registration Number: NCT04275258
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-19
• Study Start: 2020-06-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-08-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan	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.

Primary Outcome Measures

Name	Time	Method
Primary opioid outcome: percent of patients at or below their pre-trauma opioid daily dose	24 weeks	Percent of patients at or below pre-trauma opioid dose
Primary pain outcome: Pain, Enjoyment, General Activity (PEG)	24 weeks	Patient reported 0-10 pain severity, enjoyment of life interference, general activity interference total score

Secondary Outcome Measures

Name	Time	Method
PROMIS-29 health status	24 weeks	Self-reported health status: physical function, anxiety, depression, fatigue, sleep, social. role satisfaction, pain interference, pain intensity Score range 29-150. HIgher scores better on positively worded items: physical function, social role satisfaction. Higher scores worse on negatively worded items: anxiety, depression, fatigue, sleep, pain interference, pain intensity
Past-month cannabis use	24 weeks	Monitoring the Future cannabis frequency questions
satisfaction with pain care	24 weeks	HUNT3 study- patient experience with PCP. 3 items scored 0-10. Range 0-30
Illicit drug use	24 weeks	DAST-10 Drug screening questionnaire. Ten yes/no items scored 0 or 1. Score range 0-10
Problem alcohol use	24 weeks	AUDIT-C Alcohol Use Disorders Indentification Test

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States