Collaborative Care From the Emergency Department for Trauma Patients With Prescription Drug Misuse: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Establishing the Feasibility of a Collaborative Care Intervention by Measuring the Rate of Patient Consent
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Establishing the Feasibility of a Collaborative Care Intervention by Measuring the Rate of Patient Consent
时间窗: 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.
Establishing the Acceptability of a Collaborative Care Intervention by Measuring the Proportion of Enrolled Patients that Completed the Intervention in the ED
时间窗: 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.
次要结局
- Self-Reported Patient Satisfaction Using 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.)
- Self-Reported Health Care Utilization of Enrolled Patients Throughout the Study Duration(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).)
- 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 at the time of enrollment and at 1-, 3-, and 6-month follow-up assessments. This was assessed through study completion (approximately 1 year).)
- Follow-up Retention Rates(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.)
研究者
Lauren Whiteside
Acting Assistant Professor, Division of Emergency Medicine
University of Washington