Trial Outcomes & Findings for Emergency Department Longitudinal Integrated Care (NCT NCT03699085)
NCT ID: NCT03699085
Last Updated: 2023-06-22
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline
Results posted on
2023-06-22
Participant Flow
Baseline survey completed prior to randomization
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Emergency Department Longitudinal Integrated Care
Baseline characteristics by cohort
| Measure |
ED-LINC Intervention Condition
n=20 Participants
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.
|
Usual Care Condition
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
37.4 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Heroin Use
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Prescription Opioid Misuse
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Lifetime Opioid Overdose
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Potential subjects identified by suspected history of risky substance use based on EMR review
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
Outcome measures
| Measure |
Approached Subjects
n=118 Participants
Number of potential subjects who were approached for potential participation
|
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.
|
|---|---|---|
|
Refusal Rate
Refused Screening Survey
|
5 Participants
|
—
|
|
Refusal Rate
Participated in Screening Survey
|
113 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsThe number of participants who completed follow-ups at 6 month time point.
Outcome measures
| Measure |
Approached Subjects
n=20 Participants
Number of potential subjects who were approached for potential participation
|
Usual Care Condition
n=20 Participants
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.
|
|---|---|---|
|
Follow up Completion Rates
Completed 6 month followup
|
18 Participants
|
19 Participants
|
|
Follow up Completion Rates
No 6 month followup
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of participants that received at least 1 ED-LINC element
Outcome measures
| Measure |
Approached Subjects
n=20 Participants
Number of potential subjects who were approached for potential participation
|
Usual Care Condition
n=20 Participants
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.
|
|---|---|---|
|
ED-LINC Intervention and Usual Care Process Outcomes
At least 1 ED LINC element received
|
20 Participants
|
0 Participants
|
|
ED-LINC Intervention and Usual Care Process Outcomes
No ED LINC elements received
|
0 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants were asked to rate the agreeability of the statement "ED LINC seemed fitting and suitable"
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"
Outcome measures
| Measure |
Approached Subjects
n=20 Participants
Number of potential subjects who were approached for potential participation
|
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.
|
|---|---|---|
|
Implementation Appropriateness
Agreed or Completely Agreed
|
18 Participants
|
—
|
|
Implementation Appropriateness
Answered OTHER than Agreed or Completely Agreed
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsClient 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)
Outcome measures
| Measure |
Approached Subjects
n=20 Participants
Number of potential subjects who were approached for potential participation
|
Usual Care Condition
n=20 Participants
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.
|
|---|---|---|
|
ED-LINC Satisfaction
|
29 score on a scale
Interval 26.0 to 32.0
|
30 score on a scale
Interval 26.0 to 32.0
|
PRIMARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Approached Subjects
n=18 Participants
Number of potential subjects who were approached for potential participation
|
Usual Care Condition
n=19 Participants
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.
|
|---|---|---|
|
Perception of Care Coordination
|
15 score on a scale
Interval 11.25 to 19.25
|
13 score on a scale
Interval 9.0 to 15.5
|
SECONDARY outcome
Timeframe: 6 monthsComparison 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.
Outcome measures
| Measure |
Approached Subjects
n=20 Participants
Number of potential subjects who were approached for potential participation
|
Usual Care Condition
n=20 Participants
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.
|
|---|---|---|
|
Substance Use
Baseline
|
18.3 unadjusted TLFB days
Standard Error 2.89
|
16.85 unadjusted TLFB days
Standard Error 2.80
|
|
Substance Use
Month 1
|
11.95 unadjusted TLFB days
Standard Error 2.95
|
12.85 unadjusted TLFB days
Standard Error 2.93
|
|
Substance Use
Month 3
|
8.9 unadjusted TLFB days
Standard Error 2.88
|
12.45 unadjusted TLFB days
Standard Error 3.13
|
|
Substance Use
Month 6
|
13.1 unadjusted TLFB days
Standard Error 2.92
|
9.4 unadjusted TLFB days
Standard Error 3.06
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Emergency department (ED) utilization will be assessed using the Emergency Department Information Exchange (EDIE) .
Outcome measures
Outcome data not reported
Adverse Events
ED-LINC Intervention Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lauren Whiteside, Primary Investigator
University of Washington
Phone: 206-744-8464
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place