Collaborative Care From the ED for Trauma Patients With Prescription Drug Misuse
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

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.
    

Detailed description: 
      The investigators will be conducting an open pilot trial of a collaborative care intervention
      for patients in the Emergency Department (ED) with trauma and prescription drug misuse. Since
      this is an open trial, all enrolled participants will receive the intervention.

      Pre Screen: Prior to approach, the Research Assistant (RA) will review the electronic medical
      record (EMR) in the ED to first identify patients presenting for an injury and then to
      determine if they are at risk for prescription drug misuse. The manual chart review
      information will be entered by the RA into an Excel spreadsheet or equivalent. This process
      allows the team to identify patients who are at high risk for prescription drug misuse prior
      to approach.

      Approach and Consent: Next, the RA will go to the Emergency Department (ED) or inpatient ward
      and describe the study to the patient. Informed consent will be obtained from those patients
      who agree to participate in the protocol.

      Eligibility Screening: After consent and enrollment, the RA will provide each consenting
      subject with a tablet computer so they can self- administer the screening assessment. If the
      subject requires assistance, the RA can administer the screening assessment. This will
      include some basic demographic items and a validated survey developed by the National
      Institute on Drug Abuse (NIDA). Subjects will screen into the study if they have a score of
      greater than 1 on this validated survey, which indicates having risk for prescription drug
      misuse. Next, subjects will answer questions regarding contact information including phone
      number, email and address and travel plans. Since the intervention phase for this study
      requires multiple contacts and longitudinal engagement, this information is important to
      inform enrollment. The administration of this stage of screening will take approximately
      10-15 minutes. As one of the aims for this study is refining follow-up procedures, every
      participant must have plans to a) be in the local area for six months (e.g. no long-term
      travel plans or plans to relocate) b) have at least two contacts and c) have a phone number.

      All eligible subjects that meet the eligibility requirements documented above will complete a
      baseline survey using a tablet computer and will be enrolled into the intervention condition.
      This is an open trial and thus all consenting eligible subjects will receive the
      intervention.

      Collaborative Care Intervention: Subjects that are eligible for the intervention after
      screening will be visited by a study care manager at the bedside in the hospital. This care
      manager will use motivational interviewing techniques to elicit and target for improvement
      each subject's unique constellation of concerns and needs. The care manager will also ask
      about treatment preferences and will schedule ongoing times to meet/call the subject during
      the initial days and weeks post-injury. The care manager will give the subject the study
      team's 24-hour contact number and encourage calls for spontaneous questions, needs, and
      concerns. These subjects will be given a choice of treatment options and the care manager
      will share information and deliberate medical treatment decisions with each subject. Together
      the care manager and subject will develop a treatment plan informed by each subject's injury
      and medical needs, substance abuse needs, prescription medication needs and concerns. The
      collaborative care intervention will be comprised of the following elements based on
      participant's need:

        1. Medication Management: This element of the intervention will focus on appropriate
           medication guidelines for prescription opioids, and patient comorbidities as well as
           providing guideline adherence recommendations for opioid prescribing in acute and
           primary care settings.

        2. Care coordination and linkage: Intervention team members will work collaboratively with
           acute and primary care providers in an effort to coordinate care longitudinally through
           outpatient follow-up. The care manager will meet subjects at their outpatient
           appointments whenever possible. The care manager will also attempt to establish primary
           care linkages for each subject. Stepped, higher intensity care linkages will be
           available for subjects with severe mental health needs or substance abuse needs.

        3. Care management:

      Care manager supervision: After the initial evaluation, the care manager will discuss each
      participant and their needs with study PI and team. As indicated, the PI and/or the care
      manager will be in contact with study participants via phone after team meetings to monitor
      side effects of new medications or for adjustments to the recommended pharmacotherapy plan.
      The care manager will receive standard clinical supervision delivered by study members.

      Follow-up Assessments: Each participant will be contacted to complete a follow-up assessment
      at 1-month, 3-months and 6-months after their hospital visit for injury. The follow-up
      assessment will be completed in person, over the phone or via internet using the method
      preferred by the participant.
    

Intervention name(s): Collaborative Care Intervention
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Prescription Drug; Misuse