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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrienne James; Phone Number: 206-744-4634; Email: ajames1@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • Harborview Medical Center
      • Contact: Mark Sullivan, MD; Phone Number: 206-949-2744; Email: sullimar@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-29 health status	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	24 weeks
Illicit drug use	DAST-10 Drug screening questionnaire. Ten yes/no items scored 0 or 1. Score range 0-10	24 weeks
Problem alcohol use	AUDIT-C Alcohol Use Disorders Indentification Test	24 weeks
Past-month cannabis use	Monitoring the Future cannabis frequency questions	24 weeks
satisfaction with pain care	HUNT3 study- patient experience with PCP. 3 items scored 0-10. Range 0-30	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Percent of eligible patients approached, consented, assessed and contacted after discharge. Percent of primary care providers reached for at least one contact	24 weeks
Sustainability	Cost comparison of implementing collaborative opioid taper support vs. control	24 weeks
Fidelity	Degree to which the interventionist PA delivered the program as intended	24 weeks
Adoption	Uptake of the collaborative care intervention by PCPS (% of PCPs making contact)	24 weeks
Acceptability of Intervention Measure (AIM)	Level of satisfaction with the collaborative opioid taper program- 4 item measure range 4-20	24 weeks
Intervention Appropriateness Measure (IAM)	Perceived fit of the collaborative taper program with primary care practice4 item measure range 4-20	24 weeks
PCP Feasibility of Intervention Measure (FIM) 4 item measure range 4-20	PCP ease of engagement during collaborative care contacts	24 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Centers for Disease Control and Prevention; Harborview Injury Prevention and Research Center
• Investigators: Principal Investigator: Mark Sullivan, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Substance-Related Disorders; Pain, Postoperative; Wounds and Injuries; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: STUDY00008440; 1 R49CE003087-01-00 (Other Grant/Funding Number: CDC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes