Substance-Related Disorders Clinical Trial
Official title:
Collaborative Care From the Emergency Department for Trauma Patients With Prescription Drug Misuse: A Feasibility Study
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label
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