Substance-Related Disorders Clinical Trial
Official title:
Collaborative Care From the Emergency Department for Trauma Patients With Prescription Drug Misuse: A Feasibility Study
Verified date | June 2016 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Establishing the Feasibility of a Collaborative Care Intervention by Measuring the Rate of Patient Consent | 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. | This outcome was measured during active recruitment of patients in the ED until recruitment completion, which lasted 5 months. | No |
Primary | Establishing the Acceptability of a Collaborative Care Intervention by Measuring the Proportion of Enrolled Patients that Completed the Intervention in the ED | 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. | This outcome was measured during active recruitment of patients in the ED until recruitment completion, which lasted 5 months. | No |
Secondary | Self-Reported Patient Satisfaction Using the Client Satisfaction Questionnaire-8 (CSQ-8) | This outcome measures self-reported patient satisfaction with the collaborative care intervention as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8). | 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. | No |
Secondary | Self-Reported Health Care Utilization of Enrolled Patients Throughout the Study Duration | 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). | 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). | No |
Secondary | Self-Reported Substance Use of Enrolled Patients as Assessed by the NIDA Modified-Alcohol, Smoking, and Substance Involvement Screening Test (NM-ASSIST) | 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). | 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). | No |
Secondary | Follow-up Retention Rates | 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. | 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. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05054738 -
CRP and S&A for Inpatient Veterans
|
N/A | |
Recruiting |
NCT04157062 -
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
|
N/A | |
Completed |
NCT02233738 -
Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
|
N/A | |
Enrolling by invitation |
NCT06084221 -
Fatal Overdose Review Teams - Research to Enhance Surveillance Systems
|
N/A | |
Completed |
NCT02907944 -
Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation
|
N/A | |
Completed |
NCT02829970 -
Helping College Students With ADHD Lead Healthier Lifestyles
|
N/A | |
Completed |
NCT02570360 -
Exercise and Treatment-as-usual in Substance Use Treatment Outcomes
|
N/A | |
Completed |
NCT02388243 -
The Computer-based Drug and Alcohol Training Assessment in Kenya
|
N/A | |
Completed |
NCT02715557 -
Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers
|
N/A | |
Completed |
NCT02945371 -
Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life
|
N/A | |
Completed |
NCT02125539 -
Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment
|
Phase 2 | |
Completed |
NCT01633138 -
Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
|
N/A | |
Completed |
NCT02218970 -
The Effect of Muscular Strength Training in Patients With Drug Addiction
|
N/A | |
Completed |
NCT01591239 -
Home-Based Program to Help Parents of Drug Abusing Adolescents
|
N/A | |
Active, not recruiting |
NCT01539525 -
Screening to Augment Referral to Treatment- Project START
|
Phase 2 | |
Withdrawn |
NCT01224002 -
A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine
|
N/A | |
Withdrawn |
NCT00891631 -
Primary Care iSBIRT to Reduce Serious Teen Health Risks
|
Phase 1/Phase 2 | |
Completed |
NCT01365247 -
Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT00970372 -
Dual-Diagnosis and Compulsory Treatment
|
N/A | |
Completed |
NCT00419029 -
Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
|
N/A |