Emergency Department, Opioid-use Disorder
Conditions
Keywords
Opioid Use, Emergency Department, Collaborative Care
Brief 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. 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.
Interventions
BEHAVIORALED-LINC
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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Individuals on the study team designated to conduct follow up interviews will be blinded to which arm participants belong to.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perception of Care Coordination | 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. |
| Implementation Appropriateness | 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 | 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) |
| Refusal Rate | 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 | 6 months | The number of participants who completed follow-ups at 6 month time point. |
| ED-LINC Intervention and Usual Care Process Outcomes | 6 months | Number of participants that received at least 1 ED-LINC element |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Care Utilization | 6 months | Emergency department (ED) utilization will be assessed using the Emergency Department Information Exchange (EDIE) . |
| Substance Use | 6 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
Baseline survey completed prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| ED-LINC Intervention Condition 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.
ED-LINC: 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. | 20 |
| Usual Care Condition 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | ED-LINC Intervention Condition | Total | Usual Care Condition |
|---|---|---|---|
| Age, Continuous | 35.5 years STANDARD_DEVIATION 10.7 | 37.4 years STANDARD_DEVIATION 10 | 39.4 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 36 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Heroin Use | 19 Participants | 38 Participants | 19 Participants |
| Lifetime Opioid Overdose | 10 Participants | 23 Participants | 13 Participants |
| Prescription Opioid Misuse | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 11 Participants | 23 Participants | 12 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 8 Participants | 18 Participants | 10 Participants |
| Sex: Female, Male Male | 12 Participants | 22 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
ED-LINC Intervention and Usual Care Process Outcomes
Number of participants that received at least 1 ED-LINC element
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Approached Subjects | ED-LINC Intervention and Usual Care Process Outcomes | At least 1 ED LINC element received | 20 Participants |
| Approached Subjects | ED-LINC Intervention and Usual Care Process Outcomes | No ED LINC elements received | 0 Participants |
| Usual Care Condition | ED-LINC Intervention and Usual Care Process Outcomes | At least 1 ED LINC element received | 0 Participants |
| Usual Care Condition | ED-LINC Intervention and Usual Care Process Outcomes | No ED LINC elements received | 20 Participants |
Primary
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)
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Approached Subjects | ED-LINC Satisfaction | 29 score on a scale |
| Usual Care Condition | ED-LINC Satisfaction | 30 score on a scale |
Primary
Follow up Completion Rates
The number of participants who completed follow-ups at 6 month time point.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Approached Subjects | Follow up Completion Rates | Completed 6 month followup | 18 Participants |
| Approached Subjects | Follow up Completion Rates | No 6 month followup | 2 Participants |
| Usual Care Condition | Follow up Completion Rates | Completed 6 month followup | 19 Participants |
| Usual Care Condition | Follow up Completion Rates | No 6 month followup | 1 Participants |
Primary
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
Time frame: 6 months
Population: Participants were asked to rate the agreeability of the statement ED LINC seemed fitting and suitable
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Approached Subjects | Implementation Appropriateness | Agreed or Completely Agreed | 18 Participants |
| Approached Subjects | Implementation Appropriateness | Answered OTHER than Agreed or Completely Agreed | 2 Participants |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Approached Subjects | Perception of Care Coordination | 15 score on a scale |
| Usual Care Condition | Perception of Care Coordination | 13 score on a scale |
Comparison: Wilcoxon rank-sum test is used, which ranks the values in each group, sums the ranks and determines the probability that they are the same. The probability p-value is reported.p-value: 0.38Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Baseline
Population: Potential subjects identified by suspected history of risky substance use based on EMR review
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Approached Subjects | Refusal Rate | Refused Screening Survey | 5 Participants |
| Approached Subjects | Refusal Rate | Participated in Screening Survey | 113 Participants |
Secondary
Health Care Utilization
Emergency department (ED) utilization will be assessed using the Emergency Department Information Exchange (EDIE) .
Time frame: 6 months
Population: Data was unable to be obtained during the funding period. No data collection of EDIE utilization occurred during this study because team was unable to access EDIE data.
Secondary
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Approached Subjects | Substance Use | Baseline | 18.3 unadjusted TLFB days | Standard Error 2.89 |
| Approached Subjects | Substance Use | Month 1 | 11.95 unadjusted TLFB days | Standard Error 2.95 |
| Approached Subjects | Substance Use | Month 3 | 8.9 unadjusted TLFB days | Standard Error 2.88 |
| Approached Subjects | Substance Use | Month 6 | 13.1 unadjusted TLFB days | Standard Error 2.92 |
| Usual Care Condition | Substance Use | Month 6 | 9.4 unadjusted TLFB days | Standard Error 3.06 |
| Usual Care Condition | Substance Use | Baseline | 16.85 unadjusted TLFB days | Standard Error 2.8 |
| Usual Care Condition | Substance Use | Month 3 | 12.45 unadjusted TLFB days | Standard Error 3.13 |
| Usual Care Condition | Substance Use | Month 1 | 12.85 unadjusted TLFB days | Standard Error 2.93 |
Comparison: Comparison of control and intervention populations 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. This is a covariate-adjusted mixed effects regression model at TLFB timepoint of 6 months. A number greater than 1.0 indicates a higher incidence of heroin use in the past 30 days at the 6 month timepoint for intervention group compared to control group.p-value: 0.6895% CI: [0.38, 4.37]Regression, Cox