Pain, Postoperative Clinical Trial
Official title:
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.
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). |
Country | Name | City | State |
---|---|---|---|
United States | Harborview Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Centers for Disease Control and Prevention, Harborview Injury Prevention and Research Center |
United States,
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 |
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