This study seeks to test a new model of care (ID/LAB) in which opioid use disorder (OUD) is managed by infectious disease (ID) specialists and hospitalists concurrent with management of the OUD-related infections, using long-acting injectable buprenorphine (LAB), followed by referral as soon as possible after hospital discharge to community resources for long term treatment of OUD.
There are three specific aims that this study will use to assess a new model of care aimed at treating opioid use disorder (OUD). These aims address whether treatment is maintained by patients, if patients' opioid use outcomes improve and to determine if adherence to treatment for infectious disease results in fewer re-hospitalizations and emergency room visits, as well as improved quality of life. The specific aims: Aim1: The primary outcome will be a binary indicator of whether a patient is enrolled in and receiving effective medication treatment for OUD (buprenorphine, methadone, or injection naltrexone) at 12 weeks (3 months) after randomization. Aim 2: Evidence of improved opioid use outcomes (lower days of using opioids, negative urine opioids). Aim 3: Have higher rates of completion of the antimicrobial regimen for their infectious disease, decreased re-hospitalizations and emergency room presentations related to either their infectious disease or OUD over the 12-week follow-up period, and improved measures of quality of life. The intent of this study is to test the hypothesis: Assignment to the ID/LAB arm (OUD managed directly by the infectious disease (ID) specialists or hospitalist team with long acting injection buprenorphine (LAB)) will promote greater enrollment in effective medication treatment for OUD at 12 weeks after randomization, compared to TAU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
171
ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
Yale New Haven Hospital
New Haven, Connecticut, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Number of Participants With Retention in Medication Treatment for OUD
Enrollment in effective medication treatment for OUD (either buprenorphine maintenance, methadone maintenance, or extended-release naltrexone) will be ascertained through interview of the participant at each assessment point, using a modified, brief version of the Treatment Services Review that records type and dose of medication treatment, contact information on the treatment program, and psychosocial treatment modalities accessed since the previous visit (e.g. professional counseling, 12-step group participation). The primary outcome will be a binary indicator of whether or not the patient is enrolled on buprenorphine maintenance treatment or other effective medication (methadone maintenance or extended-release naltrexone) at 12 weeks after randomization, verified by either report from the treatment program, or if the treatment program does not respond, prescription drug monitoring report or EMR.
Time frame: 12 weeks
Total Days of Using Opioids
This outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.
Time frame: 4 weeks
Total Days of Using Opioids
This outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.
Time frame: 8 weeks
Total Days of Using Opioids
This outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.
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Time frame: 12 weeks
Total Days of Using Opioids
This outcome will be measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use route of use and form of drug, for the 30 days before baseline, and for each day over the follow up period, using calendars and memory aids to enhance recall.
Time frame: 24 weeks
Negative Urine Screens: Opioids
This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Time frame: 4 weeks
Negative Urine Screens: Opioids
This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Time frame: 8 weeks
Negative Urine Screens: Opioids
This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Time frame: 12 weeks
Negative Urine Screens: Opioids
This outcome will be measured by urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use.
Time frame: 24 weeks
Treatment Completion Rate
This outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.
Time frame: 4 weeks
Treatment Completion Rate
This outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.
Time frame: 8 weeks
Treatment Completion Rate
This outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.
Time frame: 12 weeks
Treatment Completion Rate
This outcome is assessed by the Medical/Infectious Disease/TAU questionnaire. This form documents the completion of antimicrobial therapy and re-hospitalization for infection. The initial evaluation documents the relevant infection and medical details such as infection site, organism, and stage. It also extracts the type of ant-infective, route of administration, dose, and planned duration. Information on follow-up is collected alteration of treatment plan, infection related adverse events (e.g. PICC complications, drug reaction/toxicity to anti-infective agent prescribed by non-study clinicians, etc), and intervening hospitalizations. Completion success is defined as appropriate completion of antimicrobial therapy, as documented in the initial assessment, without interruption or unexpected prolongation of therapy.
Time frame: 24 weeks
Re-hospitalization/Emergency Room Visits
Re-hospitalizations and emergency room presentations related to either their infectious disease or OUD will be totaled over the intervention duration and 12-week follow-up period.
Time frame: 12 weeks
Re-hospitalization/Emergency Room Visits
Re-hospitalizations and emergency room presentations related to either their infectious disease or OUD will be totaled over the intervention duration and 12-week follow-up period.
Time frame: 24 weeks
Quality of Life Measure of Social and Occupational Functioning
Quality of life is measured using the WHOQOL-Bref, which is a is a well validated and widely used scale for persons with substance use disorders that measures the quality of social and occupational functioning as well as other domains. Scores are scaled in a positive direction (higher scores indicate a higher quality of life). A total of 500 is the highest score attainable and indicates highest quality of life in respondents.
Time frame: 12 weeks
Quality of Life Measure of Social and Occupational Functioning
Quality of life is measured using the WHOQOL-Bref, which is a is a well validated and widely used scale for persons with substance use disorders that measures the quality of social and occupational functioning as well as other domains. Scores are scaled in a positive direction (higher scores indicate a higher quality of life). A total of 500 is the highest score attainable and indicates highest quality of life in respondents.
Time frame: 24 weeks