Implementation and Effectiveness of A Bundled Intervention to End Opioid Overdoses by Increasing Treatment Uptake Post Discharge
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- participant retention rate
研究概览
简要总结
Opioid overdose deaths have reached historically high records in the United States and are particularly concentrated among patients after emergency department (ED) discharge. Evidence-based treatment modules to reduce repeat opioid overdose and mortality are lacking in this patient population. A bundled intervention is proposed, including telehealth, peer support specialist, buprenorphine, and linkage for definitive care, that is designed to increase treatment uptake in this patient population post-ED discharge, reduce repeat opioid overdoses, and end overdose deaths.
详细描述
This study is supported by the Helping to End Addiction Long-term (HEAL) Initiative (https://heal.nih.gov). Opioid overdose deaths have reached historically high records in the United States. and are particularly concentrated among patients after emergency department (ED) discharge. Medications for opioid use disorder (MOUDs), including buprenorphine, are the most effective treatments for opioid use disorder (OUD) as MOUD reduce opioid-related overdoses and deaths. Despite this, less than 30% patients with OUD are treated with MOUDs. Furthermore, adequate treatment with MOUD can be more difficult in certain patient population, i.e., patients with nonfatal opioid overdoses after ED discharge. This patient population also accounts for substantial health care utilization, frequent ED visits, and the largest at-risk group for repeat overdoses and even deaths. Many barriers, including patients' stigma on MOUDs, lack of appropriate monitoring and support, difficulty in navigating community-based treatment programs and being connected with buprenorphine clinics for continuity of care, have been identified as contributors to poor treatment uptake post-ED discharge. These barriers present a pressing need to develop novel treatment modules. Peer support models and telehealth have been successful in improving service provision and increasing treatment uptake in substance use disorders. However, it remains untested if a bundled intervention of telehealth, peers, buprenorphine, and linkage to definitive addiction programs can increase treatment uptake in this particular population. Thus, the purpose of this proposal is to test this bundled intervention specifically focusing on patients with OUD and nonfatal opioid overdoses post-ED discharge.
In the R33 phase, participants will be enrolled and randomized to either the intervention group (N=80) or the usual care group (UC) (N=80). Patients will be enrolled from the same ED and same eligibility criteria as in the R61 phase will be applied. Randomization will be computer-generated using permuted blocks and will be stratified by age, sex at birth, ethnicity, comorbid diseases, and recruitment site (inpatient unit or emergency department) to ensure balanced allocation across groups. This study is open-label; participants and study staff will not be blinded to treatment assignment. In the intervention group, peers and physicians will provide the same intervention to patients as in the R61 phase, including peer support specialists meeting participants prior to ED discharge, scheduled telehealth contact throughout the 12-week period, and physician-led buprenorphine prescribing and management via telehealth. At the conclusion of the 12-week intervention, participants will receive a warm handoff from the peer support specialist to facilitate linkage to long-term community-based addiction treatment and recovery resources. Patients in the usual care group will receive the standard care that has been established at the ED, including ED-initiated buprenorphine, and a list of community-based substance treatment programs and buprenorphine clinics at ED discharge. However, no further intervention will be provided in the usual care group. Follow-up assessments will be completed at 1 and 3 months via survey links sent to participants' cell phones and/or emails through Research Electronic Data Capture (REDCap), with reminder messages sent twice daily for 5 days prior to each assessment. Primary outcomes will be increased treatment uptake and retention after ED discharge, and reduced opioid overdoses and ED revisits, compared to the usual care group. If successful, this project will lay the groundwork for a multi-site trial to validate the treatment and to identify actual implementation and sustainability barriers and best practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •discharged from the ED and inpatient settings at the UAB hospital
- •19 years or older (the age of majority in Alabama);
- •diagnosis of OUD and experiencing opioid overdose in the last 12 months;
- •prescribed buprenorphine in the ED and willing to continue buprenorphine post-ED discharge;
- •English speaking;
- •not actively psychotic and suicidal, or cognitively impaired.
- •Patients who are admitted to the hospital from the ED will be eligible for enrollment.
排除标准
- •living in a restricted environment (e.g., prison or jail facility, etc.);
- •currently enrolled in other clinical studies;
- •anticipated to take other prescribed opioids except buprenorphine for a medical condition longer than three months;
- •known allergic reaction to buprenorphine;
- •critically ill or injured;
- •females with pregnancy (they are anticipated to request a higher level of care).
- •living outside of Alabama
研究组 & 干预措施
Experimental (Bundled Intervention)
Participants will be enrolled and randomized (stratified) to the experimental (bundled intervention) group. Bundled intervention components include scheduled peer support contacts, buprenorphine treatment with addiction physicians using telehealth, and linkage to definitive addiction treatment programs, up to 3 months after Emergency Department (ED)/hospital discharge. Participants will complete baseline surveys on the day of informed consent. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.
干预措施: Bundled intervention (Experimental) (Other)
Experimental (Bundled Intervention)
Participants will be enrolled and randomized (stratified) to the experimental (bundled intervention) group. Bundled intervention components include scheduled peer support contacts, buprenorphine treatment with addiction physicians using telehealth, and linkage to definitive addiction treatment programs, up to 3 months after Emergency Department (ED)/hospital discharge. Participants will complete baseline surveys on the day of informed consent. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.
干预措施: Buprenorphine (Experimental) (Drug)
Experimental (Bundled Intervention)
Participants will be enrolled and randomized (stratified) to the experimental (bundled intervention) group. Bundled intervention components include scheduled peer support contacts, buprenorphine treatment with addiction physicians using telehealth, and linkage to definitive addiction treatment programs, up to 3 months after Emergency Department (ED)/hospital discharge. Participants will complete baseline surveys on the day of informed consent. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.
干预措施: Scheduled Peer Support Specialist (Experimental) (Behavioral)
Experimental (Bundled Intervention)
Participants will be enrolled and randomized (stratified) to the experimental (bundled intervention) group. Bundled intervention components include scheduled peer support contacts, buprenorphine treatment with addiction physicians using telehealth, and linkage to definitive addiction treatment programs, up to 3 months after Emergency Department (ED)/hospital discharge. Participants will complete baseline surveys on the day of informed consent. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.
干预措施: Telemedicine Buprenorphine Treatment (Other)
Control (Usual Care)
Participants randomized to the control group will receive the usual care established at University of Alabama at Birmingham (UAB) Hospital. Current usual care includes a thorough assessment, buprenorphine initiation as appropriate, peer referral, and a written list of buprenorphine clinics. Participants will also receive information about community-based substance use treatment programs; however, these services are at the participant's own discretion to navigate and attend after ED discharge. Participants will complete baseline surveys on the day of informed consent. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.
干预措施: control group (Other)
结局指标
主要结局
participant retention rate
时间窗: 1 month and 3 months post hospital discharge
measure the total number of participants who complete 1- month and 3-month treatment in the study
buprenorphine adherence rate
时间窗: 1 month and 3 months post ED discharge
checking prescription rate and patients' self report of their taking medication
linkage rate to addiction treatment programs
时间窗: 1 month and 3 months post hospital discharge
patients' self report and reports from addiction treatment programs
Frequency of Repeat Opioid Overdose
时间窗: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Repeat opioid overdose events monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital
Healthcare Utilization (Hospital Revisit Rates)
时间窗: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Opioid overdose-related hospital revisits after the initial ED encounter, monitored via EMR documentation at UAB Hospital
Adherence to Peer Support Specialist Contact
时间窗: Throughout the 12-week intervention period post hospital discharge
Rate of participant adherence to the scheduled peer support specialist contact protocol, including daily contact in Week 1, every other day contact in Week 2, and weekly contact in Weeks 3-12 post-ED discharge, as recorded in peer activity logs documenting dates, times, and length of each telehealth contact
Opioid Overdose Death
时间窗: Monitored quarterly throughout the R33 study period beyond the 3-month intervention
Opioid overdose deaths monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital
次要结局
- Childhood Trauma Questionnaire (CTQ)([Time Frame: Baseline, 1-month, and 3-month post hospital discharge])
- Overdose Risk Scale (ORISK)([Time Frame: Baseline, 1-month and 3-month post hospital discharge])
- Patient Satisfaction Scale (PSS)([Time Frame: Baseline, 1-month and 3-month post hospital discharge])
- Credibility and Expectancy Questionnaire (CEQ)([Time Frame: 1-month and 3-month post hospital discharge])
- Barratt Impulsiveness Scale (BIS)([Time Frame: Baseline, 1-month, and 3-month post hospital discharge])
- Generalized Anxiety Disorder 7 (GAD-7)([Time Frame: Baseline, 1-month, and 3-month post hospital discharge])
- Patient Health Questionnaire 9 (PHQ-9)([Time Frame: Baseline, 1-month, and 3-month post hospital discharge])
- Opioid Craving Scale (Craving)([Time Frame: Baseline, 1-month, and 3-month post hospital discharge])
- Pittsburgh Sleep Quality Index (PSQI)([Time Frame: Baseline, 1-month, and 3-month post hospital discharge])
- changes in quality of Life(Baseline, 1-month and 3-month post hospital discharge)
- Mental Health Status(Baseline, 1-month (25-35 days), and 3-month (85-95 days) post hospital discharge)
研究者
Li Li
Full Professor
University of Alabama at Birmingham