This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder (AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two phases. The first phase (N=10) will use implementation science strategies to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability, and linkage pathways. The second phase (N=20) will incorporate lessons learned from phase 1 to initiate ED patients on MAT for AUD in the form of oral naltrexone. The primary outcome for both phase 1 and phase 2 is engagement in comprehensive addiction treatment at 14 and 30 days post enrollment.
Overview The study will be comprised of two components outlined below: 1. Site Implementation Component In this component implementation science strategies will be used to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability and linkage pathways. Three specific aims are to, 1) optimize registered nurse (RN) driven non-targeted alcohol use screening supplemented with secondary screening using DSM-5 criteria for AUD and an SBIRT (screening, brief intervention and referral to treatment) intervention administered by trained staff. 2) During a 3-month period, use continuous quality improvement methods to decrease the time for completion of AUD screening to an interval that is acceptable to ED patients and ED providers and 3) Assess willingness to initiate oral naltrexone among ED patients with moderate to severe AUD. Ten (10) patients will be enrolled in phase 1. 2. Oral Naltrexone Feasibility Component In this component the study team aims to assess the feasibility of initiating treatment in ED patients with moderate to severe AUD on oral naltrexone, an evidence based and accepted standard of care treatment for AUD. Specifically, 1) over an 8-month period the study team aims to identify 20 patients with moderate to severe AUD eligible and interested in immediate initiation of oral naltrexone. Consenting patients will be receive a standard SBIRT intervention and be provided with immediate oral naltrexone initiation in the ED with a 14-day starter pack at the time of ED discharge. All participants will receive facilitated linkage to comprehensive out-patient care. 2) The study team aims will evaluate the impact of immediate ED initiated oral naltrexone with the primary outcome being engagement in comprehensive addiction care at 14 and 30 days post enrollment. Secondary outcomes include medication adherence, changes in daily alcohol consumption, number of heavy drinking days, hospital admissions and ED utilization, transition to long-acting injectable naltrexone and alcohol craving. 3) Lastly, the study team will collect data on recruitment and attrition rates, as well as means and standard deviations for key measures that will be needed to plan a definitive randomized controlled trial of ED-initiated oral naltrexone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
30
Emergency Department Initiated Oral Naltrexone
Mount Sinai Beth Israel
New York, New York, United States
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14
Number of participant enrolled with engagement in care of comprehensive addiction treatment
Time frame: Day 14
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30
Number of participant enrolled with engagement in care of comprehensive addiction treatment
Time frame: Day 30
Number of Alcoholic Drinks Per Day
Baseline
Time frame: 7-days prior to enrollment to day of enrollment (baseline)
Number of Daily Drinks
30-days
Time frame: 30-days
Daily Alcohol Craving Scale
Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity.
Time frame: up to 30 days
Guidelines Regimen Information Program (GRIP) Guide at Day 14
Adherence to daily oral naltrexone measured using Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores mean better adherence.
Time frame: Day 14
Guidelines Regimen Information Program (GRIP) Guide at Day 30
Adherence to daily oral naltrexone measured using the Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores represent better adherence.
Time frame: Day 30
Number of Pills in Bottle at Day 14
Adherence to daily oral naltrexone measured using pill counts.
Time frame: Day 14
Number of Pills in Bottle at Day 30
Adherence to daily oral naltrexone measured using pill counts.
Time frame: Day 30
Number of Heavy Drinking Days
Number of heavy drinking days defined as 4 or more drinks for a woman or 5 or more drinks for a man on the same occasion in a 24 hour period.
Time frame: up to 30 days
Health Services Utilization Survey
Participants indicated the number of inpatient admissions, outpatient visits and emergency department visits over the preceding 7-days at baseline up to 30-days. Comparison of total reported admissions or visits were made using the Friedman test. No admissions or visits counted as a 0 for comparing across timepoints. If no response was provided at any of the three time points, the participant data was not used in the comparison.
Time frame: up to 30-days
Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL)
Number of unhealthy days using the HRQoL. The HRQoL assesses core health days and activity limitations. Self-reported general health was collected on a 5-item scale ranging from: excellent, very good, good, fair, and poor. An unhealthy days score was obtained by summing the number of physically unhealthy and mentally unhealthy days. The minimum score is 0 and the maximum score is 30 unhealthy days, even if the number of unhealthy days totals more than 30. If no response was provided at the time points under comparison, the participant data was not used in the comparison.
Time frame: Day 30
The Patient Rated Inventory of Side Effects (PRISE) Survey
Medication side effects of oral naltrexone measured using PRISE survey - is a patient self-report measure used to identify and evaluate the tolerability of side effect symptom. This scale is a 7-item assessment of the side effects in the following symptom areas; gastrointestinal, heart, skin, nervous system, eyes/ears, genital/urinary, sleep, sexual functioning, and other. Each domain has multiple symptoms and for each domain the patient rates whether these symptoms are tolerable or distressing. Higher score represents more side-effects. What is reported below are the number of participants reporting side effects for each symptom.
Time frame: Day 30
AUD Program Satisfaction Survey at Baseline
Three elements of satisfaction were assessed: 1) convenience of screening, 2) difficulty of screening and 3) satisfaction with screening. Each question could be scored on scale of 0-6. For convenience of screening, lower numbers indicated more convenience. For difficulty of screening, lower numbers represent less difficulty. For satisfaction, higher numbers represent greater satisfaction.
Time frame: Baseline
Number of Participants Who Transition to LA Injectable
Number of participants who transition from oral to long acting injectable naloxone.
Time frame: Day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.