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Collaborative Care From the ED for Trauma Patients With Prescription Drug Misuse

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ClinicalTrials.gov Identifier: NCT02804295
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Lauren Whiteside, University of Washington

Brief Summary:
Injured trauma patients in the Emergency Department (ED) may be a particularly important group to target for screening and intervention for prescription drug misuse (PDM). These patients have high rates of psychiatric and substance use co-morbidity and pain management for their injuries (e.g. broken bones, burns) will often require prescribed opioid pain medications and other controlled substances. To date, there are no effective ED-based interventions for PDM. Collaborative Care is a longitudinal model of care that combines multiple elements for patients with complex medical comorbidities. This model holds promise as an intervention strategy for injured patients in the ED that are at risk for prescription drug misuses. Collaborative Care from the ED is innovative and requires developing follow up procedures on a population that has previously been difficult to follow and may have previously avoided consistent health care delivery. The primary objective of this study was to determine the feasibility of initiating a collaborative care intervention for injured ED patients with PDM by enrolling patients into an open trial of this intervention. A secondary objective was to determine if PDM decreases over time after enrollment and developing successful follow-up procedures to deliver longitudinal care.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Other: Collaborative Care Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Collaborative Care From the Emergency Department for Trauma Patients With Prescription Drug Misuse: A Feasibility Study
Study Start Date : January 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Collaborative Care Intervention
All enrolled participants received the collaborative care intervention over 6 months.
Other: Collaborative Care Intervention
All eligible subjects that meet the eligibility requirements for approach and consent and have a positive screen for PDM will complete a baseline survey and will be enrolled into the intervention condition. This is an open trial and thus all consenting eligible subjects will receive the intervention.




Primary Outcome Measures :
  1. Establishing the Feasibility of a Collaborative Care Intervention by Measuring the Rate of Patient Consent [ Time Frame: This outcome was measured during active recruitment of patients in the ED until recruitment completion, which lasted 5 months. ]
    The primary outcome of intervention feasibility was assessed by measuring the rate of eligible patients that consented and enrolled in the intervention upon approach by the research assistant.

  2. Establishing the Acceptability of a Collaborative Care Intervention by Measuring the Proportion of Enrolled Patients that Completed the Intervention in the ED [ Time Frame: This outcome was measured during active recruitment of patients in the ED until recruitment completion, which lasted 5 months. ]
    The primary outcome of intervention acceptability was assessed by measuring the proportion of consented patients that completed the collaborative care intervention in the ED with members of the intervention team.


Secondary Outcome Measures :
  1. Self-Reported Patient Satisfaction Using the Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: Patient satisfaction was measured upon completion of the intervention for each patient, after the patient's 6-month follow-up assessment. Measurement for this outcome lasted approximately 6 months. ]
    This outcome measures self-reported patient satisfaction with the collaborative care intervention as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8).

  2. Self-Reported Health Care Utilization of Enrolled Patients Throughout the Study Duration [ Time Frame: Patients self-reported their health care utilization at the time of enrollment and at 1-, 3-, and 6-month follow-up assessments. This was assessed through study completion (approximately 1 year). ]
    Patients self-reported their health care utilization (including ED utilization, visits to primary care doctors, specialists, etc.) at time of enrollment (health care utilization for the past 6 months) and at 1-, 3-, and 6-month follow-up assessments (health care utilization since last assessment).

  3. Self-Reported Substance Use of Enrolled Patients as Assessed by the NIDA Modified-Alcohol, Smoking, and Substance Involvement Screening Test (NM-ASSIST) [ Time Frame: Patients self-reported their substance use at the time of enrollment and at 1-, 3-, and 6-month follow-up assessments. This was assessed through study completion (approximately 1 year). ]
    Patients self-reported their substance use using the NM-ASSIST measure at time of enrollment (reported substance use for the past 6 months) and at 1-, 3-, and 6-month follow-up assessments (reported substance use since last assessment).

  4. Follow-up Retention Rates [ Time Frame: Follow-up rates for enrolled patients at 1-, 3-, and 6-months post enrollment were measured throughout the duration of the study through study completion, which lasted approximately one year. ]
    Follow-up retention rates of enrolled patients (i.e. patients that complete follow-up assessments at 1-, 3-, and 6-months post enrollment) are measured for each follow-up assessment time period (1-, 3-, and 6-months post enrollment). These follow-up assessments began 1-month after the first subject was recruited and continued for up to 6 months after the recruitment of the last subject.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (18-65 years old) presenting to Harborview Medical Center in Seattle, Washington with an injury from 02/2015 to 09/2015 were screened for eligibility based on historical codes in the electronic medical record (EMR) that increase their risk for prescription drug misuse. The items pulled from electronic medical charts for a pre-screen include: History of opioid, sedative or stimulant abuse or dependence, history of opioid overdose, current opioid prescriptions, co-occurring prescriptions for opioids and sedatives, previous ED visit at Harborview Medical Center (HMC) attributable to substance use, number of ED visits in the past year. Possible participants who met this eligibility criteria were approached by the research assistant. Consented patients completed a screening assessment for PDM based on NIDA m-ASSIST for prescription opioids, sedatives and stimulants and select questions from the Current Opioid Misuse Measure. Participants with a positive screen for PDM were enrolled in the 'Prescription Collaborative Care (RxCC)' intervention.

Exclusion Criteria:

  • Participants were excluded if they were incarcerated or under arrest, required active resuscitation in the ED or other clinical area at the time of RA approach, had a diagnosis of cancer or are receiving palliative or hospice care, were in the ED or hospital for a primary psychiatric emergency such as suicidal ideation or attempt, lived beyond a 50 mile radius of HMC, or did not have reliable contact information.
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Responsible Party: Lauren Whiteside, Acting Assistant Professor, Division of Emergency Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02804295    
Other Study ID Numbers: 48977-G
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lauren Whiteside, University of Washington:
Prescription Drug
Misuse
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders