Recruiting

Opioid Taper

Sponsor:

University of Washington

Code:

NCT04275258

Conditions

Opioid Use

Pain, Postoperative

Opioid Use, Unspecified

Trauma

Opioid-use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT04275258

Start date

Jun 1, 2020

Status verified date

Apr, 2021

Completion date

Jan 31, 2022

Anticipated

Primary completion date

Aug 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Primary pain outcome: Pain, Enjoyment, General Activity (PEG) [ Time Frame: 24 weeks ]
  • Primary opioid outcome: percent of patients at or below their pre-trauma opioid daily dose [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

More Information

Sponsor

University of Washington

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2021-04-28.