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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275258
• Other study ID #: STUDY00008440
• Secondary ID: 1 R49CE003087-01
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2021
• Source: University of Washington
• Contact: Adrienne James
• Phone: 206-744-4634
• Email: ajames1[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Opioid Use
• Opioid Use, Unspecified
• Opioid-use Disorder
• Pain, Postoperative
• Substance-Related Disorders
• Trauma
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Centers for Disease Control and Prevention, Harborview Injury Prevention and Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Sustainability	Cost comparison of implementing collaborative opioid taper support vs. control	24 weeks
Other	Fidelity	Degree to which the interventionist PA delivered the program as intended	24 weeks
Other	Adoption	Uptake of the collaborative care intervention by PCPS (% of PCPs making contact)	24 weeks
Other	Acceptability of Intervention Measure (AIM)	Level of satisfaction with the collaborative opioid taper program- 4 item measure range 4-20	24 weeks
Other	Intervention Appropriateness Measure (IAM)	Perceived fit of the collaborative taper program with primary care practice4 item measure range 4-20	24 weeks
Other	PCP Feasibility of Intervention Measure (FIM) 4 item measure range 4-20	PCP ease of engagement during collaborative care contacts	24 weeks
Primary	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	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	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
Secondary	Illicit drug use	DAST-10 Drug screening questionnaire. Ten yes/no items scored 0 or 1. Score range 0-10	24 weeks
Secondary	Problem alcohol use	AUDIT-C Alcohol Use Disorders Indentification Test	24 weeks
Secondary	Past-month cannabis use	Monitoring the Future cannabis frequency questions	24 weeks
Secondary	satisfaction with pain care	HUNT3 study- patient experience with PCP. 3 items scored 0-10. Range 0-30	24 weeks