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).
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-07-14
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
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.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 46 | - |
| ID/LAB | 86 | 51 | - |
Eligibility
primary outcomes
Time frame: 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 outcomes
Time frame: 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.
Time frame: From Week 4 to 8
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 since the last assessment, using calendars and memory aids to enhance recall.
Time frame: From Week 8 to 12
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 since the last assessment, using calendars and memory aids to enhance recall.
Time frame: 24 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.
Time frame: 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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: 12 weeks
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.
Publications
No exact PMID-linked public article is currently readable locally.
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 7.95 | 1.74 |
| ID/LAB | 86 | 9.15 | 1.89 |
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 since the last assessment, using calendars and memory aids to enhance recall.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 12.09 | 2.07 |
| ID/LAB | 86 | 13.20 | 1.93 |
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 since the last assessment, using calendars and memory aids to enhance recall.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 12.50 | 2.13 |
| ID/LAB | 86 | 11.25 | 2.08 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 15.17 | 2.08 |
| ID/LAB | 86 | 14.38 | 2.00 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 85 | - |
| ID/LAB | 86 | 86 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 51 | - |
| ID/LAB | 86 | 49 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 50 | - |
| ID/LAB | 86 | 57 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 47 | - |
| ID/LAB | 86 | 56 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 53 | - |
| ID/LAB | 86 | 55 | - |
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.
Population: Data only collected for those that completed treatment.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 67 | - |
| ID/LAB | 86 | 61 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 18 | - |
| ID/LAB | 86 | 13 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 82.53 | 1.97 |
| ID/LAB | 86 | 86.77 | 1.87 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 82.69 | 2.23 |
| ID/LAB | 86 | 87.28 | 1.87 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 3.7 | 0.368 |
| ID/LAB | 86 | 3.76 | 0.514 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 3.58 | 0.529 |
| ID/LAB | 86 | 3.65 | 0.534 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 3.68 | 0.447 |
| ID/LAB | 86 | 2.82 | 0.476 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 3.41 | 0.49 |
| ID/LAB | 86 | 2.78 | 0.54 |
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 15 | - |
| ID/LAB | 86 | 21 | - |
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 17 | - |
| ID/LAB | 86 | 12 | - |
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 25 | - |
| ID/LAB | 86 | 19 | - |
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 20 | - |
| ID/LAB | 86 | 17 | - |
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 2 | - |
| ID/LAB | 86 | 1 | - |
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 2 | - |
| ID/LAB | 86 | 3 | - |
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 2 | - |
| ID/LAB | 86 | 3 | - |
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 2 | - |
| ID/LAB | 86 | 1 | - |
Participants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). · Yes | 85 | 41 | - |
| ID/LAB · Yes | 86 | 47 | - |
| Treatment as Usual (TAU). · No | 85 | 44 | - |
| ID/LAB · No | 86 | 39 | - |
Participants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). · Yes | 85 | 35 | - |
| ID/LAB · Yes | 86 | 30 | - |
| Treatment as Usual (TAU). · No | 85 | 50 | - |
| ID/LAB · No | 86 | 56 | - |
Number of participants that had an Unplanned Medical Discharge at baseline
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 84 | 14 | - |
| ID/LAB | 85 | 10 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 84 | 68 | - |
| ID/LAB | 82 | 65 | - |
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
Population: Only those diagnosed with HCV at registration provided these data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 59 | 40 | - |
| ID/LAB | 56 | 38 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 2 | 0 | - |
| ID/LAB | 1 | 0 | - |
Mean days participants have injected drugs in the last 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 6.5 | 2.03 |
| ID/LAB | 86 | 8.37 | 2.08 |
Mean days participants have injected drugs in the last 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 10.37 | 2.47 |
| ID/LAB | 86 | 12.79 | 2.04 |
Mean days participants have injected drugs in the last 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 10.34 | 2.39 |
| ID/LAB | 86 | 10.76 | 2.23 |
Mean days participants have injected drugs in the last 28 days
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 13.15 | 2.36 |
| ID/LAB | 86 | 13.39 | 2.13 |
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 4.83 | 1.46 |
| ID/LAB | 86 | 6.76 | 1.71 |
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 8.13 | 1.78 |
| ID/LAB | 86 | 7.8 | 1.79 |
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 10.85 | 1.73 |
| ID/LAB | 86 | 6.74 | 1.73 |
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 13.76 | 2.00 |
| ID/LAB | 86 | 8.63 | 2.01 |
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 30 | - |
| ID/LAB | 86 | 37 | - |
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 31 | - |
| ID/LAB | 86 | 30 | - |
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 37 | - |
| ID/LAB | 86 | 31 | - |
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment as Usual (TAU). | 85 | 37 | - |
| ID/LAB | 86 | 24 | - |
| Milestone | Treatment as Usual (TAU). | ID/LAB |
|---|---|---|
| STARTED | 85 | 86 |
| missed 12 week visit | 18 | 16 |
| COMPLETED | 63 | 59 |
| NOT COMPLETED | 22 | 27 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 4 / 86 |
| Other (Epistaxis) | Blood and lymphatic system disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Thromboembolic event | Blood and lymphatic system disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 3 / 86 |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Superficial thrombophlebitis | Blood and lymphatic system disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Cardiac disorders - Other, specify | Cardiac disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Acute coronary syndrome | Cardiac disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Cardiac arrest | Cardiac disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Hypertension | Cardiac disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Myocardial infarction | Cardiac disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Tricuspid valve disease | Cardiac disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Atrioventricular block complete | Cardiac disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 1 / 86 |
| Surgical and medical procedures - Other, specify | Cardiac disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 1 / 86 |
| Heart failure | Cardiac disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 1 / 86 |
| Pericardial effusion | Cardiac disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 1 / 86 |
| Urinary tract infection | Renal and urinary disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 1 / 86 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 2 / 86 |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Lung infection | Respiratory, thoracic and mediastinal disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 3 / 86 |
| Skin infection | Skin and subcutaneous tissue disorders | Treatment as Usual (TAU).: 4 / 85 · ID/LAB: 5 / 86 |
| Skin ulceration | Skin and subcutaneous tissue disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Other (Incarceration) | Social circumstances | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Hypotension | Vascular disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Stroke | Vascular disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Hyperglycemia | Endocrine disorders | Treatment as Usual (TAU).: 2 / 85 · ID/LAB: 0 / 86 |
| Endocrine disorders - Other, specify | Endocrine disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Stomach pain | Gastrointestinal disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Colitis | Gastrointestinal disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Other (Adominal Pain) | Gastrointestinal disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Endocarditis infective | Infections and infestations | Treatment as Usual (TAU).: 3 / 85 · ID/LAB: 5 / 86 |
| Sepsis | Infections and infestations | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 3 / 86 |
| Bone infection | Infections and infestations | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 3 / 86 |
| Infections and infestations - Other, specify | Infections and infestations | Treatment as Usual (TAU).: 5 / 85 · ID/LAB: 6 / 86 |
| Lung infection | Infections and infestations | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 3 / 86 |
| Soft tissue infection | Infections and infestations | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 1 / 86 |
| Paronychia | Infections and infestations | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Wound infection | Infections and infestations | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Wound complication | Infections and infestations | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Prostate infection | Infections and infestations | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Pelvic infection | Infections and infestations | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Other (Overdose) | Injury, poisoning and procedural complications | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Other (Opioid Withdrawal) | Injury, poisoning and procedural complications | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Other (Meth Use) | Injury, poisoning and procedural complications | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Hypokalemia | Metabolism and nutrition disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Arthralgia | Musculoskeletal and connective tissue disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Nervous system disorders - Other, specify | Nervous system disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Seizure | Nervous system disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Psychosis | Psychiatric disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 1 / 86 |
| Suicidal ideation | Psychiatric disorders | Treatment as Usual (TAU).: 4 / 85 · ID/LAB: 1 / 86 |
| Suicide attempt | Psychiatric disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 0 / 86 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Opioid Withdrawal | Nervous system disorders | Treatment as Usual (TAU).: 9 / 85 · ID/LAB: 14 / 86 |
| Skin/soft tissue infection | Skin and subcutaneous tissue disorders | Treatment as Usual (TAU).: 9 / 85 · ID/LAB: 7 / 86 |
| Arthralgia | Musculoskeletal and connective tissue disorders | Treatment as Usual (TAU).: 6 / 85 · ID/LAB: 8 / 86 |
| Nausea | Gastrointestinal disorders | Treatment as Usual (TAU).: 5 / 85 · ID/LAB: 10 / 86 |
| Rash | Skin and subcutaneous tissue disorders | Treatment as Usual (TAU).: 7 / 85 · ID/LAB: 7 / 86 |
| Headache | Nervous system disorders | Treatment as Usual (TAU).: 4 / 85 · ID/LAB: 9 / 86 |
| Edema | Vascular disorders | Treatment as Usual (TAU).: 6 / 85 · ID/LAB: 5 / 86 |
| Abdominal pain | Gastrointestinal disorders | Treatment as Usual (TAU).: 6 / 85 · ID/LAB: 5 / 86 |
| Myalgia | Musculoskeletal and connective tissue disorders | Treatment as Usual (TAU).: 4 / 85 · ID/LAB: 6 / 86 |
| Injection site reaction | General disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 9 / 86 |
| Vomiting | Gastrointestinal disorders | Treatment as Usual (TAU).: 4 / 85 · ID/LAB: 4 / 86 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Treatment as Usual (TAU).: 4 / 85 · ID/LAB: 4 / 86 |
| Constipation | Gastrointestinal disorders | Treatment as Usual (TAU).: 1 / 85 · ID/LAB: 7 / 86 |
| Diaphoresis | General disorders | Treatment as Usual (TAU).: 3 / 85 · ID/LAB: 4 / 86 |
| Fatigue | General disorders | Treatment as Usual (TAU).: 5 / 85 · ID/LAB: 2 / 86 |
| Fever | Immune system disorders | Treatment as Usual (TAU).: 3 / 85 · ID/LAB: 4 / 86 |
| Non-fatal opioid overdose | Nervous system disorders | Treatment as Usual (TAU).: 6 / 85 · ID/LAB: 1 / 86 |
| Insomnia | Nervous system disorders | Treatment as Usual (TAU).: 2 / 85 · ID/LAB: 4 / 86 |
| Anemia | Blood and lymphatic system disorders | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 5 / 86 |
Time frame: 24 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 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.
Time frame: 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.
Time frame: 8 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.
Time frame: 12 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.
Time frame: 24 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.
Time frame: 4 Weeks
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Time frame: 8 Weeks
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Time frame: 12 Weeks
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Time frame: 24 Weeks
Number of Participants Who Had Vaginal or Anal Sex Without a Condom in the Past 28 days
Time frame: 4 Weeks
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
Time frame: 8 Weeks
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
Time frame: 12 Weeks
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
Time frame: 24 Weeks
Number of Participants Who Had A Needle Sharing Activity in the Past 28 days
Time frame: 12 Weeks
Participants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No.
Time frame: 24 Weeks
Participants were asked if they were currently satisfied with their MOUD (Medication for Opioid Use Disorder). Responses were Yes / No.
Time frame: baseline
Number of participants that had an Unplanned Medical Discharge at baseline
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 4 weeks
Mean days participants have injected drugs in the last 28 days
Time frame: 8 weeks
Mean days participants have injected drugs in the last 28 days
Time frame: 12 weeks
Mean days participants have injected drugs in the last 28 days
Time frame: 24 weeks
Mean days participants have injected drugs in the last 28 days
Time frame: 4 weeks
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
Time frame: 8 weeks
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
Time frame: 12 weeks
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
Time frame: 24 weeks
Mean days using other drugs/alcohol (including THC) in last 28 days by self-report
Time frame: 4 weeks
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
Time frame: 8 weeks
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
Time frame: 12 weeks
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
Time frame: 24 weeks
Number of participants with Urine toxicology positive for non-opioid drugs (including THC)
| Back pain |
| Musculoskeletal and connective tissue disorders |
| Treatment as Usual (TAU).: 4 / 85 · ID/LAB: 0 / 86 |
| Respiratory infection (not including COVID-19) | Infections and infestations | Treatment as Usual (TAU).: 0 / 85 · ID/LAB: 4 / 86 |