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| ID | Type | Description | Link |
|---|---|---|---|
| U01TR002763 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU | Active Comparator | Treatment as Usual (TAU). |
|
| ID/LAB | Experimental | Infectious Disease management of OUD with Long-Acting injectable buprenorphine (ID/LAB). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID/LAB | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Springer, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States | ||
| Penn State Health Milton S. Hershey Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40445619 | Derived | Seval N, Roth P, Frank CA, Di Paola A, Litwin AH, Vander Wyk B, Neirinckx V, Schlossberg E, Lawson P, Strong M, Schade MA, Nunez J, Levin FR, Brady KT, Nunes EV, Springer SA. Initiating Injectable Buprenorphine in People Hospitalized With Infections: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2513000. doi: 10.1001/jamanetworkopen.2025.13000. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 12 weeks |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Opioid Withdrawal | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Opioid Withdrawal | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra Springer, MD | Yale School of Medicine | 877-554-3578 | sandra.springer@yale.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2023 | Jan 30, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2019 | Jan 29, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Not provided
Not provided
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| TAU | Other | 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. |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 24 weeks |
| Hershey |
| Pennsylvania |
| 17033 |
| United States |
| Prisma Health | Greenville | South Carolina | 29650 | United States |
| Withdrawal by Subject |
|
| incarcerated |
|
| Physician Decision |
|
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Housing Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Income group | Count of Participants | Participants |
|
| Type of insurance | Count of Participants | Participants |
|
| Engaged in condomless sex | Count of Participants | Participants |
|
| Median number of condomless sex partners | Median | Inter-Quartile Range | partners |
|
| WHO Quality of Life-BREF (WHOQOL-BREF) | Assesses quality of life in four domains: physical health, psychological, social relationships and environment. The domain scores were transformed into a linear scale with a range of 0-100. Higher scores indicate a better quality of life. | Median | Inter-Quartile Range | score on a scale |
|
| Provisional Post-traumatic stress disorder (PTSD) Diagnosis | Diagnosed via the Post-Traumatic Diagnostic Scale 5 (PTSD - PCL) | Count of Participants | Participants |
|
| Depression Severity | Diagnosed via Patient Health Questionnaire-9 (PHQ-9) | Count of Participants | Participants |
|
| Provisional Attention-deficit/hyperactivity disorder (ADHD) | Diagnosed via Adult ADHD Self-Report Scale | Count of Participants | Participants |
|
| Pain Scale score via Pain, Enjoyment of Life and General Activity (PEG) Scale | Scored on a scale of 0-10. A higher score indicates more pain and worse functioning. | Median | Inter-Quartile Range | score on a scale |
|
| Opioid Craving Scale | Score range 0-5. Higher scores indicate more cravings. | Median | Inter-Quartile Range | score on a scale |
|
| Opioid withdrawal (mild or greater) | Assessed via Clinical Opiate Withdrawal Scale (COWS). | Count of Participants | Participants |
|
| Hazardous/Harmful Drinking | Assessed via Alcohol Use Disorders Identification Test (AUDIT). | Count of Participants | Participants |
|
| Co-occurring stimulant use disorder | Assessed via Mini Internation Neuropsychiatric Interview (MINI) | Count of Participants | Participants |
|
| Prescribed MOUD in past 30 days | Count of Participants | Participants |
|
| Positive urine toxicology screen at time of enrollment | Count of Participants | Participants |
|
| Self-reported substances used 30 days prior to hospitalization | Assessed via TLFB | Count of Participants | Participants |
|
| Visited health care provider in last 12 months, excluding urgent care | Count of Participants | Participants |
|
| Covered by health insurance 30 days before interview | Count of Participants | Participants |
|
| Engaged in injection drug use | Count of Participants | Participants |
|
| Shared injection drug equipment | Count of Participants | Participants |
|
| Index Infection | Count of Participants | Participants |
|
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. |
| OG001 | 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). |
|
|
|
| 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. | Not Posted | 4 weeks | Participants |
| 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. | Not Posted | 8 weeks | Participants |
| 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. | Not Posted | 12 weeks | Participants |
| 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. | Not Posted | 24 weeks | Participants |
| 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. | Not Posted | 4 weeks | Participants |
| 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. | Not Posted | 8 weeks | Participants |
| 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. | Not Posted | 12 weeks | Participants |
| 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. | Not Posted | 24 weeks | Participants |
| 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. | Not Posted | 4 weeks | Participants |
| 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. | Not Posted | 8 weeks | Participants |
| 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. | Not Posted | 12 weeks | Participants |
| 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. | Not Posted | 24 weeks | Participants |
| 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. | Not Posted | 12 weeks | Participants |
| 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. | Not Posted | 24 weeks | Participants |
| 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. | Not Posted | 12 weeks | Participants |
| 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. | Not Posted | 24 weeks | Participants |
| 4 |
| 85 |
| 20 |
| 85 |
| 68 |
| 85 |
| EG001 | 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). | 4 | 86 | 31 | 86 | 67 | 86 |
| Skin/soft tissue infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Non-fatal opioid overdose | Nervous system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory infection (not including COVID-19) | Infections and infestations | Systematic Assessment |
|
| Skin/soft tissue infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Edema | Vascular disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Injection site reaction | General disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diaphoresis | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | Immune system disorders | Systematic Assessment |
|
| Non-fatal opioid overdose | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Respiratory infection (not including COVID-19) | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
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| Missing |
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| Missing |
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| Missing |
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| Missing |
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| Missing |
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| Missing |
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| Missing |
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