Opioid-use Disorder
Conditions
Brief summary
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.
Detailed description
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. Secondary Outcome measures were updated at time of results entry.
Interventions
OTHERID/LAB
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).
OTHERTAU
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.
Sponsors
Yale University
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults able to provide written informed consent in English or Spanish; * Current hospitalization with a suspected or known bacterial or viral (HIV/HCV/HBV) infection including but not limited to bacteremia, Candidal fungemia, osteomyelitis, endophthalmitis, septic thrombophlebitis, infected pseudoaneurysm, endocarditis, skin/soft tissue infection (SSTI), or septic arthritis; * Current moderate-to-severe OUD (DSM-5); * Willing to accept assignment to either ID/LAB or TAU, and to participate in research follow-up visits.
Exclusion criteria
* Severe medical or psychiatric disability making participation unsafe (e.g. imminent suicide risk); * Pregnancy, planning conception, or breast-feeding for female participants; * Allergy, hypersensitivity or medical contraindication to buprenorphine; * Moderate-severe liver impairment in the judgment of the study investigator; * Preexisting enrollment on methadone or buprenorphine (SL-B) maintenance AND intending to remain on methadone or buprenorphine maintenance upon discharge (patients already under effective treatment for OUD do not represent the target population of untreated OUD patients entering hospitals, nor would we want to disrupt established effective treatment). * Inability or unwillingness of subject to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Retention in Medication Treatment for OUD | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days of Using Opioids | 4 weeks | 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 using calendars and memory aids to enhance recall. |
| Negative Urine Screens: Opioids | 1 week | This outcome will be measured by the number of participants with urine toxicology-confirmed abstinence via urine toxicology (Manufacturer: Redwood Toxicology) for recent illicit opioid use. |
| Treatment Completion | 12 weeks | 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. Data presented here is the number of participants that successfully completed treatment. |
| Re-hospitalization/Emergency Room Visits | 12 weeks | 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. These data are operationalized as the total number of patients experiencing rehospitalization by 12 Weeks. |
| Quality of Life Measure of Social and Occupational Functioning | 12 weeks | Quality of life is measured using the World Health Organization Quality Of Life short tool (WHOQOL-Bref), which is a is a well validated and widely used 26-question tool for persons with substance use disorders that measures the perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. Scores range from a minimum of 0 to a maximum of 130. Higher scores indicate a higher quality of life. |
| Mean Modified PEG Pain Scale Score | 4 weeks | A modified version of the Brief Pain Inventory (BPI), focusing on pain intensity and interference with enjoyment of life and general activity. Total score range 0-10 with higher scores indicating greater pain and interference. |
| Number of Participants Who Had Sex Without a Condom in the Past 28 Days to Assess HIV Risk Behavior | 4 Weeks | Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days |
| Number of Participants Who Had A Needle Sharing Activity in the Past 28 Days to Assess HIV Risk Behavior | 4 Weeks | Number of Participants Who Had A Needle Sharing Activity in the Past 28 days |
| Treatment Satisfaction | 12 Weeks | Participants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No. |
| Unplanned Medical Discharge | baseline | Number of participants that had an Unplanned Medical Discharge at baseline |
| Cure of Index Infection | 12 Weeks | Number of participants cured of index infection. Clinical adjudication was made based on EHR review including documentation from treating providers, laboratory analyses, available microbiologic information, and imaging. |
| Number of Participants With Hepatitis C (HCV) Detectable Viral Load | 12 Weeks | Number of participants with HCV detectable viral load, as determined through RNA polymerase chain reaction (PCR) testing. A viral load above 15 international units per liter (IU/L) is considered detectable and is an indication of active infection and that treatment should be considered |
| Number of Participants With Detectable HIV Viral Load | up to 12 Weeks | Number of participants with a viral load by nucleic acid amplification test of more than 200 IU/mL, of those with HIV. A viral load of 200 copies/mL or less is considered 'undetectable' with no risk of HIV transmission. |
| Mean Days Injecting Drugs | 4 weeks | Mean days participants have injected drugs in the last 28 days |
| Mean Days Other Drug Use | 4 weeks | Mean days using other drugs/alcohol (including THC) in last 28 days by self-report |
| Urine Toxicology: Positive Screens | 4 weeks | Number of participants with Urine toxicology positive for non-opioid drugs (including THC) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSandra Springer, MD
Yale University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment as Usual (TAU). Treatment as Usual (TAU).
TAU: 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. | 85 |
| ID/LAB Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB).
ID/LAB: 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). | 86 |
| Total | 171 |
Baseline characteristics
| Characteristic | Treatment as Usual (TAU). | Total | ID/LAB |
|---|---|---|---|
| Age, Continuous | 40 years | 39 years | 38 years |
| Co-occurring stimulant use disorder | 48 Participants | 92 Participants | 44 Participants |
| Covered by health insurance 30 days before interview | 46 Participants | 96 Participants | 50 Participants |
| Depression Severity Did not answer | 2 Participants | 5 Participants | 3 Participants |
| Depression Severity Moderate or above | 57 Participants | 117 Participants | 60 Participants |
| Depression Severity None or mild | 26 Participants | 49 Participants | 23 Participants |
| Education Did not respond | 0 Participants | 2 Participants | 2 Participants |
| Education High School or above | 68 Participants | 135 Participants | 67 Participants |
| Education Less than high school | 17 Participants | 34 Participants | 17 Participants |
| Engaged in condomless sex Did not respond | 1 Participants | 6 Participants | 5 Participants |
| Engaged in condomless sex No | 36 Participants | 71 Participants | 35 Participants |
| Engaged in condomless sex Yes | 48 Participants | 94 Participants | 46 Participants |
| Engaged in injection drug use Missing | 1 Participants | 2 Participants | 1 Participants |
| Engaged in injection drug use No | 31 Participants | 52 Participants | 21 Participants |
| Engaged in injection drug use Yes | 53 Participants | 117 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 18 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants | 153 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hazardous/Harmful Drinking | 23 Participants | 38 Participants | 15 Participants |
| Housing Status Stable Housing | 27 Participants | 61 Participants | 34 Participants |
| Housing Status Unhoused | 21 Participants | 42 Participants | 21 Participants |
| Housing Status Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Housing Status Unstable Housing | 37 Participants | 67 Participants | 30 Participants |
| Income group $10.000-24,999 | 20 Participants | 36 Participants | 16 Participants |
| Income group $25,000-49,999 | 16 Participants | 33 Participants | 17 Participants |
| Income group $50,000 or more | 15 Participants | 32 Participants | 17 Participants |
| Income group $5,000-9,999 | 6 Participants | 12 Participants | 6 Participants |
| Income group Less than $5,000 | 27 Participants | 52 Participants | 25 Participants |
| Income group Unknown or Not Reported | 1 Participants | 6 Participants | 5 Participants |
| Index Infection Abscess including skin/soft tissue, intra-abdominal, epidural, and other | 30 Participants | 57 Participants | 27 Participants |
| Index Infection Bloodstream infection | 36 Participants | 77 Participants | 41 Participants |
| Index Infection COVID-19 Infection | 3 Participants | 6 Participants | 3 Participants |
| Index Infection Endocarditis | 15 Participants | 35 Participants | 20 Participants |
| Index Infection Hepatitis B | 0 Participants | 2 Participants | 2 Participants |
| Index Infection Hepatitis C, Ab positive | 53 Participants | 114 Participants | 61 Participants |
| Index Infection Hepatitis C, with detectable viral load | 36 Participants | 71 Participants | 35 Participants |
| Index Infection HIV diagnosis | 3 Participants | 4 Participants | 1 Participants |
| Index Infection HIV viral load ≥ 200 | 0 Participants | 1 Participants | 1 Participants |
| Index Infection Osteomyelitis | 16 Participants | 31 Participants | 15 Participants |
| Index Infection Other | 5 Participants | 6 Participants | 1 Participants |
| Index Infection Pneumonia/respiratory infection (non-COVID-19) | 19 Participants | 33 Participants | 14 Participants |
| Index Infection Septic arthritis | 14 Participants | 28 Participants | 14 Participants |
| Index Infection Septic thrombophlebitis | 2 Participants | 4 Participants | 2 Participants |
| Index Infection Sexually transmitted infection | 3 Participants | 8 Participants | 5 Participants |
| Index Infection Skin/skin structure infection | 11 Participants | 35 Participants | 24 Participants |
| Marital Status Divorced | 18 Participants | 39 Participants | 21 Participants |
| Marital Status Living with partner | 5 Participants | 17 Participants | 12 Participants |
| Marital Status Married | 10 Participants | 21 Participants | 11 Participants |
| Marital Status Never married | 40 Participants | 69 Participants | 29 Participants |
| Marital Status Separated | 10 Participants | 18 Participants | 8 Participants |
| Marital Status Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Marital Status Widowed | 2 Participants | 6 Participants | 4 Participants |
| Median number of condomless sex partners | 1 partners | 1 partners | 1 partners |
| Opioid Craving Scale | 1.00 score on a scale | 1.00 score on a scale | 1.00 score on a scale |
| Opioid withdrawal (mild or greater) | 19 Participants | 27 Participants | 8 Participants |
| Pain Scale score via Pain, Enjoyment of Life and General Activity (PEG) Scale | 6.0 score on a scale | 6.0 score on a scale | 6.0 score on a scale |
| Positive urine toxicology screen at time of enrollment Benzodiazepine Missing | 3 Participants | 5 Participants | 2 Participants |
| Positive urine toxicology screen at time of enrollment Benzodiazepine Negative | 62 Participants | 117 Participants | 55 Participants |
| Positive urine toxicology screen at time of enrollment Benzodiazepine Positive | 20 Participants | 49 Participants | 29 Participants |
| Positive urine toxicology screen at time of enrollment Buprenorphine Missing | 5 Participants | 7 Participants | 2 Participants |
| Positive urine toxicology screen at time of enrollment Buprenorphine Negative | 29 Participants | 56 Participants | 27 Participants |
| Positive urine toxicology screen at time of enrollment Buprenorphine Positive | 51 Participants | 108 Participants | 57 Participants |
| Positive urine toxicology screen at time of enrollment Cocaine Missing | 3 Participants | 5 Participants | 2 Participants |
| Positive urine toxicology screen at time of enrollment Cocaine Negative | 77 Participants | 158 Participants | 81 Participants |
| Positive urine toxicology screen at time of enrollment Cocaine Positive | 5 Participants | 8 Participants | 3 Participants |
| Positive urine toxicology screen at time of enrollment Fentanyl Missing | 4 Participants | 6 Participants | 2 Participants |
| Positive urine toxicology screen at time of enrollment Fentanyl Negative | 42 Participants | 86 Participants | 44 Participants |
| Positive urine toxicology screen at time of enrollment Fentanyl Positive | 39 Participants | 79 Participants | 40 Participants |
| Positive urine toxicology screen at time of enrollment Methadone Missing | 4 Participants | 6 Participants | 2 Participants |
| Positive urine toxicology screen at time of enrollment Methadone Negative | 67 Participants | 129 Participants | 62 Participants |
| Positive urine toxicology screen at time of enrollment Methadone Positive | 14 Participants | 36 Participants | 22 Participants |
| Positive urine toxicology screen at time of enrollment Methamphetamine Missing | 3 Participants | 5 Participants | 2 Participants |
| Positive urine toxicology screen at time of enrollment Methamphetamine Negative | 70 Participants | 147 Participants | 77 Participants |
| Positive urine toxicology screen at time of enrollment Methamphetamine Positive | 12 Participants | 19 Participants | 7 Participants |
| Positive urine toxicology screen at time of enrollment Opiates Missing | 3 Participants | 5 Participants | 2 Participants |
| Positive urine toxicology screen at time of enrollment Opiates Negative | 71 Participants | 132 Participants | 61 Participants |
| Positive urine toxicology screen at time of enrollment Opiates Positive | 11 Participants | 34 Participants | 23 Participants |
| Positive urine toxicology screen at time of enrollment Oxycodone Missing | 3 Participants | 5 Participants | 2 Participants |
| Positive urine toxicology screen at time of enrollment Oxycodone Negative | 62 Participants | 126 Participants | 64 Participants |
| Positive urine toxicology screen at time of enrollment Oxycodone Positive | 20 Participants | 40 Participants | 20 Participants |
| Prescribed MOUD in past 30 days | 15 Participants | 34 Participants | 19 Participants |
| Provisional Attention-deficit/hyperactivity disorder (ADHD) | 50 Participants | 112 Participants | 62 Participants |
| Provisional Post-traumatic stress disorder (PTSD) Diagnosis | 48 Participants | 93 Participants | 45 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 14 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 10 Participants | 2 Participants |
| Race (NIH/OMB) White | 63 Participants | 137 Participants | 74 Participants |
| Region of Enrollment United States | 85 participants | 171 participants | 86 participants |
| Self-reported substances used 30 days prior to hospitalization Cocaine Missing | 1 Participants | 2 Participants | 1 Participants |
| Self-reported substances used 30 days prior to hospitalization Cocaine No | 56 Participants | 111 Participants | 55 Participants |
| Self-reported substances used 30 days prior to hospitalization Cocaine Yes | 28 Participants | 58 Participants | 30 Participants |
| Self-reported substances used 30 days prior to hospitalization Fentanyl Missing | 1 Participants | 2 Participants | 1 Participants |
| Self-reported substances used 30 days prior to hospitalization Fentanyl No | 45 Participants | 94 Participants | 49 Participants |
| Self-reported substances used 30 days prior to hospitalization Fentanyl Yes | 39 Participants | 75 Participants | 36 Participants |
| Self-reported substances used 30 days prior to hospitalization Heroin Missing | 1 Participants | 2 Participants | 1 Participants |
| Self-reported substances used 30 days prior to hospitalization Heroin No | 27 Participants | 54 Participants | 27 Participants |
| Self-reported substances used 30 days prior to hospitalization Heroin Yes | 57 Participants | 115 Participants | 58 Participants |
| Self-reported substances used 30 days prior to hospitalization Methamphetamine Missing | 1 Participants | 2 Participants | 1 Participants |
| Self-reported substances used 30 days prior to hospitalization Methamphetamine No | 45 Participants | 89 Participants | 44 Participants |
| Self-reported substances used 30 days prior to hospitalization Methamphetamine Yes | 39 Participants | 80 Participants | 41 Participants |
| Self-reported substances used 30 days prior to hospitalization Other opioids Missing | 1 Participants | 2 Participants | 1 Participants |
| Self-reported substances used 30 days prior to hospitalization Other opioids No | 78 Participants | 154 Participants | 76 Participants |
| Self-reported substances used 30 days prior to hospitalization Other opioids Yes | 6 Participants | 15 Participants | 9 Participants |
| Self-reported substances used 30 days prior to hospitalization Prescription opioids Missing | 1 Participants | 2 Participants | 1 Participants |
| Self-reported substances used 30 days prior to hospitalization Prescription opioids No | 68 Participants | 132 Participants | 64 Participants |
| Self-reported substances used 30 days prior to hospitalization Prescription opioids Yes | 16 Participants | 37 Participants | 21 Participants |
| Sex/Gender, Customized Men | 42 Participants | 88 Participants | 46 Participants |
| Sex/Gender, Customized Transgender women | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Women | 43 Participants | 82 Participants | 39 Participants |
| Shared injection drug equipment Does not apply | 31 Participants | 52 Participants | 21 Participants |
| Shared injection drug equipment Missing | 1 Participants | 3 Participants | 2 Participants |
| Shared injection drug equipment No | 35 Participants | 77 Participants | 42 Participants |
| Shared injection drug equipment Yes | 18 Participants | 39 Participants | 21 Participants |
| Type of insurance Did not respond | 0 Participants | 1 Participants | 1 Participants |
| Type of insurance Medicaid | 38 Participants | 76 Participants | 38 Participants |
| Type of insurance Medicare | 1 Participants | 3 Participants | 2 Participants |
| Type of insurance None | 39 Participants | 74 Participants | 35 Participants |
| Type of insurance Other insurance | 1 Participants | 4 Participants | 3 Participants |
| Type of insurance Private insurance | 6 Participants | 13 Participants | 7 Participants |
| Visited health care provider in last 12 months, excluding urgent care | 34 Participants | 62 Participants | 28 Participants |
| WHO Quality of Life-BREF (WHOQOL-BREF) Environmental | 53.1 score on a scale | 56.3 score on a scale | 56.7 score on a scale |
| WHO Quality of Life-BREF (WHOQOL-BREF) Physical Health | 42.9 score on a scale | 39.3 score on a scale | 39.3 score on a scale |
| WHO Quality of Life-BREF (WHOQOL-BREF) Psychological | 45.8 score on a scale | 45.8 score on a scale | 45.8 score on a scale |
| WHO Quality of Life-BREF (WHOQOL-BREF) Social Relationships | 45.8 score on a scale | 50.0 score on a scale | 54.2 score on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 85 | 4 / 86 |
| other Total, other adverse events | 68 / 85 | 67 / 86 |
| serious Total, serious adverse events | 35 / 85 | 35 / 86 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual (TAU). | Number of Participants With Retention in Medication Treatment for OUD | 46 Participants |
| ID/LAB | Number of Participants With Retention in Medication Treatment for OUD | 51 Participants |
p-value: 0.94t-test, 2 sided
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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: 12 weeks
Secondary
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
Secondary
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
Secondary
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
Secondary
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