Opioid-use DisorderED-LINCNCT03699085
Emergency Department Longitudinal Integrated Care
A study testing ED-LINC in people with Opioid-use Disorder and Emergency Department, run by University of Washington at 1 site in United States.
Trial summary
The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. This study will provide important feasibility information for future studies of ED-LINC. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder, Emergency Department
- What is being tested?
- ED-LINC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65
- Patients with at least one risk factor for opioid use disorder via the EMR pre-screen
- Patients with score of ≥ 4 on the NIDA modified ASSIST for illicit opioids (e.g. heroin) OR a score of ≥ 4 on the NIDA modified ASSIST for prescription opioids
- Currently have a phone
- Able to provide a phone number and one additional piece of contact information
Who cannot join
- They are incarcerated or under arrest
- Non-English speaking
- Live beyond a 50 mile radius of HMC
- Require active resuscitation in the ED or other clinical area at the time of RA approach
- Are receiving palliative care services or hospice care for a chronic illness such as metastatic cancer
- Are in the ED or hospital for a primary psychiatric emergency such as suicidal ideation or attempt
- Receiving chronic opioid therapy (COT) defined as prescription opioids for most days out of the last 90 days for a chronic pain condition
- In the ED for sexual assault
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: A Longitudinal Collaborative Care Model for Patients With Opioid Problems: Emergency Department Longitudinal Integrated Care (ED-LINC)
The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. This study will provide important feasibility information for future studies of ED-LINC. The collaborative care intervention (ED-LINC) will be supported by a novel Emergency Departement (ED) health information exchange platform.
Read the detailed description
The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. According to the 2015 national survey on drug use and health, an estimated 3.8 million individuals over 12 years of age were currently misusing opioid pain relievers. An additional 329,000 people use heroin. The Emergency Department (ED) is currently at the forefront of this public health emergency and often a place where patients come for treatment of overdose and for treatment of medical problems related to illicit opioid use.
Overall, the goal is to establish the feasibility of a multi-component intervention called 'Emergency Department Longitudinal Integrated Care (ED-LINC)' which is guided by principles of collaborative care and is comprised of components that are evidence-based. ED-LINC is initiated from the ED and continues longitudinally for patients at-risk for opioid use disorder.
- Conditions
- Opioid-use Disorder, Emergency Department
- Being tested
- ED-LINC
- Keywords
- Opioid Use, Emergency Department, Collaborative Care
- Medical subject headings
- Opioid-Related Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED-LINCBehavioural
ED-LINC will include 1) A brief negotiated interview at the bedside with an emphasis on motivation to link to services 2) Pharmacotherapy including a discussion of opioid safety, take-home naloxone and initiation of buprenorphine from the ED for participants that are interested and eligible; 3) Longitudinal care management which will proceed for 3-months; and 4) Care plan in the Emergency Department Information Exchange (EDIE) system. This will be coupled with a study cell phone and a weekly supervisory case conference which is consistent with collaborative care principles.
| Study group | Role | What they receive |
|---|---|---|
| ED-LINC Intervention Condition | Experimental | Patients in this arm will receive the ED-LINC intervention. Elements of ED-LINC are based on evidence-based treatments and are central components of collaborative care. ED-LINC will be supported by a novel Emergency Department Information Exchange (EDIE) technology platform that allows for the creation of ED care plans and electronic alerts and will assist in care coordination of this complex population. Receives: Behavioral: ED-LINC |
| Usual Care Condition | No intervention | Patients in this arm may receive a spectrum of consulting services visits including social work services, psychiatric consultation, inpatient psychiatry consult, rehabilitation psychology consultation, addiction intervention services, pain team consultation services that include MD psychiatric and PhD psychologist providers, spiritual care or other consulting services which shall count as usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refusal Rate
Percentage of subjects who agree to participate in screening survey prior to determining eligibility status. Potential subjects identified by suspected risky substance use history based on EMR review
Measured: Baseline
Follow up Completion Rates
The number of participants who completed follow-ups at 6 month time point.
Measured: 6 months
ED-LINC Intervention and Usual Care Process Outcomes
Number of participants that received at least 1 ED-LINC element
Measured: 6 months
Implementation Appropriateness
Participants randomized to ED-LINC care were asked about the appropriateness of interventional activities.by rating the agreeability of the statement "ED LINC seemed fitting and suitable"
Measured: 6 months
ED-LINC Satisfaction
Client Satisfaction Questionnaire (CSQ-8) questions (8-32) will be used to assess satisfaction with ED-LINC, in which greater numbers designate higher satisfaction (32 is maximum or highest satisfaction rating possible)
Measured: 6 months
Perception of Care Coordination
The Patient Assessment of Chronic Illness Care - Coordination (PACIC-C) questions will be asked of all participants, where greater numbers indicate perception was more coordinated (greater number is better). For the scale, scores must be discrete numbers, with a minimum possible value of 5 and maximum possible value of 25.
Measured: 6 months
Secondary outcomes (2)
Substance Use
Comparison between control population and intervention population based on substance use measured utilizing a time-line follow back (TLFB) calendar administered by the research assistant to for past 30-day heroin use at TLFB timepoints (Baseline, 1 month, 3 months, 6 months). Table shows the average of unadjusted TLFB days of Heroin Use with 95% Confidence Interval.
Measured: 6 months
Health Care Utilization
Emergency department (ED) utilization will be assessed using the Emergency Department Information Exchange (EDIE) .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start11 Dec 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lauren Whiteside, University of Washington
- Investigators
- Lauren Whiteside, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699085
- Sponsor's protocol ID
- STUDY00005447
- Other IDs
- K23DA039974
- Acronym
- ED-LINC
- Status last verified
- May 2023
- First submitted
- 3 Oct 2018
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whiteside LK, Huynh L, Morse S, Hall J, Meurer W, Banta-Green CJ, Scheuer H, Cunningham R, McGovern M, Zatzick DF. The Emergency Department Longitudinal Integrated Care (ED-LINC) intervention targeting opioid use disorder: A pilot randomized clinical trial. J Subst Abuse Treat. 2022 May;136:108666. doi: 10.1016/j.jsat.2021.108666. Epub 2021 Nov 24.
PubMed 34952745
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Collaborative Care Model for Patients With Opioid Problems: Emergency Department Longitudinal Integrated Care (ED-LINC)
- ClinicalTrials.gov ID
- NCT03699085
- Acronym / sponsor ID
- ED-LINC / STUDY00005447
- Conditions
- Opioid-use Disorder, Emergency Department
- Keywords
- Opioid Use, Emergency Department, Collaborative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. This study will provide important feasibility information for future studies of ED-LINC. The collaborative care intervention (ED-LINC) will be supported by a novel Emergency Departement (ED) health information exchange platform.
Detailed description
The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. According to the 2015 national survey on drug use and health, an estimated 3.8 million individuals over 12 years of age were currently misusing opioid pain relievers. An additional 329,000 people use heroin. The Emergency Department (ED) is currently at the forefront of this public health emergency and often a place where patients come for treatment of overdose and for treatment of medical problems related to illicit opioid use.
Overall, the goal is to establish the feasibility of a multi-component intervention called 'Emergency Department Longitudinal Integrated Care (ED-LINC)' which is guided by principles of collaborative care and is comprised of components that are evidence-based. ED-LINC is initiated from the ED and continues longitudinally for patients at-risk for opioid use disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED-LINC Intervention Condition | Experimental | Behavioral: ED-LINCPatients in this arm will receive the ED-LINC intervention. Elements of ED-LINC are based on evidence-based treatments and are central components of collaborative care. ED-LINC will be supported by a novel Emergency Department Information Exchange (EDIE) technology platform that allows for the creation of ED care plans and electronic alerts and will assist in care coordination of this complex population. |
| Usual Care Condition | No intervention | –Patients in this arm may receive a spectrum of consulting services visits including social work services, psychiatric consultation, inpatient psychiatry consult, rehabilitation psychology consultation, addiction intervention services, pain team consultation services that include MD psychiatric and PhD psychologist providers, spiritual care or other consulting services which shall count as usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65
- Patients with at least one risk factor for opioid use disorder via the EMR pre-screen
- Patients with score of ≥ 4 on the NIDA modified ASSIST for illicit opioids (e.g. heroin) OR a score of ≥ 4 on the NIDA modified ASSIST for prescription opioids
- Currently have a phone
- Able to provide a phone number and one additional piece of contact information
Key exclusion criteria (8 listed)
- They are incarcerated or under arrest
- Non-English speaking
- Live beyond a 50 mile radius of HMC
- Require active resuscitation in the ED or other clinical area at the time of RA approach
- Are receiving palliative care services or hospice care for a chronic illness such as metastatic cancer
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 |
|---|---|---|
| ED-LINCED-LINC will include 1) A brief negotiated interview at the bedside with an emphasis on motivation to link to services 2) Pharmacotherapy including a discussion of opioid safety, take-home naloxone and initiation of buprenorphine from the ED for participants that are interested and eligible; 3) Longitudinal care management which will proceed for 3-months; and 4) Care plan in the Emergency Department Information Exchange (EDIE) system. This will be coupled with a study cell phone and a weekly supervisory case conference which is consistent with collaborative care principles. | Behavioural | ED-LINC Intervention Condition |
Primary outcome
Refusal Rate
Time frame: Baseline
Percentage of subjects who agree to participate in screening survey prior to determining eligibility status. Potential subjects identified by suspected risky substance use history based on EMR review
Follow up Completion Rates
Time frame: 6 months
The number of participants who completed follow-ups at 6 month time point.
ED-LINC Intervention and Usual Care Process Outcomes
Time frame: 6 months
Number of participants that received at least 1 ED-LINC element
Implementation Appropriateness
Time frame: 6 months
Participants randomized to ED-LINC care were asked about the appropriateness of interventional activities.by rating the agreeability of the statement "ED LINC seemed fitting and suitable"
ED-LINC Satisfaction
Time frame: 6 months
Client Satisfaction Questionnaire (CSQ-8) questions (8-32) will be used to assess satisfaction with ED-LINC, in which greater numbers designate higher satisfaction (32 is maximum or highest satisfaction rating possible)
Perception of Care Coordination
Time frame: 6 months
The Patient Assessment of Chronic Illness Care - Coordination (PACIC-C) questions will be asked of all participants, where greater numbers indicate perception was more coordinated (greater number is better). For the scale, scores must be discrete numbers, with a minimum possible value of 5 and maximum possible value of 25.
2 secondary outcomes
Substance Use
Time frame: 6 months
Health Care Utilization
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34952745Whiteside LK, Huynh L, Morse S, Hall J, Meurer W, Banta-Green CJ, Scheuer H, Cunningham R, McGovern M, Zatzick DF. The Emergency Department Longitudinal Integrated Care (ED-LINC) intervention targeting opioid use disorder: A pilot randomized clinical trial. J Subst Abuse Treat. 2022 May;136:108666. doi: 10.1016/j.jsat.2021.108666. Epub 2021 Nov 24.
- 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.
Lauren Whiteside, 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 ED-LINC in people with Opioid-use Disorder and Emergency Department, 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jun 2023. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refusal Rate (time frame: Baseline). The study lists 6 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 NCT03699085, 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 22 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.