Opioid UseNCT04275258
Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder
A study testing Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan in people with Opioid Use and Pain, Postoperative, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Pain, Postoperative, Opioid Use, Unspecified
- What is being tested?
- Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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).
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Harborview Medical Center
Seattle, Washington, 98195
Mark Sullivan, MD, 206-949-2744, sullimar@uw.edu
About this study
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.
Read the 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.
- Being tested
- Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan
- Medical subject headings
- Pain, Postoperative, Wounds and Injuries, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper planOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Primary pain outcome: Pain, Enjoyment, General Activity (PEG)
Patient reported 0-10 pain severity, enjoyment of life interference, general activity interference total score
Measured: 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
Measured: 24 weeks
Secondary outcomes (5)
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
Measured: 24 weeks
Illicit drug use
DAST-10 Drug screening questionnaire. Ten yes/no items scored 0 or 1. Score range 0-10
Measured: 24 weeks
Problem alcohol use
AUDIT-C Alcohol Use Disorders Indentification Test
Measured: 24 weeks
Past-month cannabis use
Monitoring the Future cannabis frequency questions
Measured: 24 weeks
satisfaction with pain care
HUNT3 study- patient experience with PCP. 3 items scored 0-10. Range 0-30
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Jun 2020
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Harborview Injury Prevention and Research Center
- Responsible party
- Principal investigator, Mark Sullivan, University of Washington
- Investigators
- Mark Sullivan, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275258
- Sponsor's protocol ID
- STUDY00008440
- Other IDs
- 1 R49CE003087-01-00, 1R49CE003087-01
- Status last verified
- Apr 2021
- First submitted
- 11 Feb 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sullivan MD, Katers L, Wang J, Arbabi S, Tauben D, Baldwin LM. A randomized trial of collaborative support for opioid taper after trauma hospitalization. Subst Abuse Treat Prev Policy. 2024 Jun 24;19(1):33. doi: 10.1186/s13011-024-00613-x.
PubMed 38915106
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04275258
- Acronym / sponsor ID
- STUDY00008440
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Harborview Injury Prevention and Research Center
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper planSubjects 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper planPA 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. | Other | Intervention group |
Primary outcome
Primary pain outcome: Pain, Enjoyment, General Activity (PEG)
Time frame: 24 weeks
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
Time frame: 24 weeks
Percent of patients at or below pre-trauma opioid dose
5 secondary outcomes
PROMIS-29 health status
Time frame: 24 weeks
Illicit drug use
Time frame: 24 weeks
Problem alcohol use
Time frame: 24 weeks
Past-month cannabis use
Time frame: 24 weeks
satisfaction with pain care
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 38915106Sullivan MD, Katers L, Wang J, Arbabi S, Tauben D, Baldwin LM. A randomized trial of collaborative support for opioid taper after trauma hospitalization. Subst Abuse Treat Prev Policy. 2024 Jun 24;19(1):33. doi: 10.1186/s13011-024-00613-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Sullivan, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan in people with Opioid Use and Pain, Postoperative, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrienne James (206-744-4634, ajames1@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary pain outcome: Pain, Enjoyment, General Activity (PEG) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04275258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.