Back to resultsCollaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder
Primary Purpose
Opioid Use, Pain, Postoperative, Opioid Use, Unspecified
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan
Sponsored by
About this trial
This is an interventional supportive care trial for Opioid Use
Eligibility Criteria
Inclusion Criteria:
- Must be at least 18 years old
- Injury Severity Score of 9 or greater
- Resident of Washington state
- Will be discharged to a rural zip code outside of king county.
- Glasgow Coma Score of 15
- Able to read, speak, and write English or Spanish.
- Has an identifiable PCP or willing to accept referral to a local Federally Qualified Health Center (FQHC)
- Has an insurer included in the All Payer Claims Database
- Planned to be discharged on opioid medication
- Planned to be discharged back to the community
Exclusion Criteria:
- Less than 18 years old
- Injury Severity Score less than 9
- Patient is in judicial custody
- Resident of a state other than Washington
- Will not be discharged to a rural zip code outside of king county.
- 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).
- Currently in cancer treatment or enrolled in palliative or hospice care
- Residing in a nursing home or assisted living facility
- Using any implanted device for pain control
- Self-report of heroin or other illicit opioid use in the past month
- Psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year (including current admission).
Sites / Locations
- Harborview Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Primary pain outcome: Pain, Enjoyment, General Activity (PEG)
Patient reported 0-10 pain severity, enjoyment of life interference, general activity interference total score
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
Secondary Outcome Measures
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
Illicit drug use
DAST-10 Drug screening questionnaire. Ten yes/no items scored 0 or 1. Score range 0-10
Problem alcohol use
AUDIT-C Alcohol Use Disorders Indentification Test
Past-month cannabis use
Monitoring the Future cannabis frequency questions
satisfaction with pain care
HUNT3 study- patient experience with PCP. 3 items scored 0-10. Range 0-30
Full Information
NCT ID
NCT04275258
First Posted
February 11, 2020
Last Updated
April 26, 2021
Sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention, Harborview Injury Prevention and Research Center
1. Study Identification
Unique Protocol Identification Number
NCT04275258
Brief Title
Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder
Official Title
Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention, Harborview Injury Prevention and Research Center
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Pain, Postoperative, Opioid Use, Unspecified, Trauma, Opioid-use Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will use a randomized controlled trial design. Patients taking opioids prior to trauma are at an increased risk for adverse opioid outcomes, therefore we will stratify randomization so that the intervention and control groups are half opioid exposed and half opioid naïve at the time of trauma, Patients with any prescription opioid use in the 30 days prior to trauma will be considered opioid-exposed, while those with no prescription opioid use in the prior 30 days will be considered opioid naïve.
Masking
Outcomes Assessor
Masking Description
The team member that coordinates subject's follow-up survey completion after hospital discharge will be masked.
Team members involved with outcome analysis will be masked.
.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan
Intervention Description
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 Information:
Title
Primary pain outcome: Pain, Enjoyment, General Activity (PEG)
Description
Patient reported 0-10 pain severity, enjoyment of life interference, general activity interference total score
Time Frame
24 weeks
Title
Primary opioid outcome: percent of patients at or below their pre-trauma opioid daily dose
Description
Percent of patients at or below pre-trauma opioid dose
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
PROMIS-29 health status
Description
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
Time Frame
24 weeks
Title
Illicit drug use
Description
DAST-10 Drug screening questionnaire. Ten yes/no items scored 0 or 1. Score range 0-10
Time Frame
24 weeks
Title
Problem alcohol use
Description
AUDIT-C Alcohol Use Disorders Indentification Test
Time Frame
24 weeks
Title
Past-month cannabis use
Description
Monitoring the Future cannabis frequency questions
Time Frame
24 weeks
Title
satisfaction with pain care
Description
HUNT3 study- patient experience with PCP. 3 items scored 0-10. Range 0-30
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Feasibility
Description
Percent of eligible patients approached, consented, assessed and contacted after discharge. Percent of primary care providers reached for at least one contact
Time Frame
24 weeks
Title
Sustainability
Description
Cost comparison of implementing collaborative opioid taper support vs. control
Time Frame
24 weeks
Title
Fidelity
Description
Degree to which the interventionist PA delivered the program as intended
Time Frame
24 weeks
Title
Adoption
Description
Uptake of the collaborative care intervention by PCPS (% of PCPs making contact)
Time Frame
24 weeks
Title
Acceptability of Intervention Measure (AIM)
Description
Level of satisfaction with the collaborative opioid taper program- 4 item measure range 4-20
Time Frame
24 weeks
Title
Intervention Appropriateness Measure (IAM)
Description
Perceived fit of the collaborative taper program with primary care practice4 item measure range 4-20
Time Frame
24 weeks
Title
PCP Feasibility of Intervention Measure (FIM) 4 item measure range 4-20
Description
PCP ease of engagement during collaborative care contacts
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be at least 18 years old
Injury Severity Score of 9 or greater
Resident of Washington state
Will be discharged to a rural zip code outside of king county.
Glasgow Coma Score of 15
Able to read, speak, and write English or Spanish.
Has an identifiable PCP or willing to accept referral to a local Federally Qualified Health Center (FQHC)
Has an insurer included in the All Payer Claims Database
Planned to be discharged on opioid medication
Planned to be discharged back to the community
Exclusion Criteria:
Less than 18 years old
Injury Severity Score less than 9
Patient is in judicial custody
Resident of a state other than Washington
Will not be discharged to a rural zip code outside of king county.
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).
Currently in cancer treatment or enrolled in palliative or hospice care
Residing in a nursing home or assisted living facility
Using any implanted device for pain control
Self-report of heroin or other illicit opioid use in the past month
Psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year (including current admission).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrienne James
Phone
206-744-4634
Email
ajames1@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sullivan, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Sullivan, MD
Phone
206-949-2744
Email
sullimar@uw.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder
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