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REBOOT is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients with opioid use disorder. It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the efficacy of REBOOT vs attention-control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Counseling Intervention | Experimental |
| |
| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REBOOT | Behavioral | The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Overdose Events | Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records. | 16 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip O Coffin, MD, MIA | San Francisco Department of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Department of Public Health | San Francisco | California | 94102 | United States | ||
| Boston Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37866442 | Derived | Harris MTH, Laks J, Hurstak E, Jain JP, Lambert AM, Maschke AD, Bagley SM, Farley J, Coffin PO, McMahan VM, Barrett C, Walley AY, Gunn CM. "If you're strung out and female, they will take advantage of you": A qualitative study exploring drug use and substance use service experiences among women in Boston and San Francisco. J Subst Use Addict Treat. 2024 Feb;157:209190. doi: 10.1016/j.josat.2023.209190. Epub 2023 Oct 20. | |
| 36069781 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Counseling Intervention | REBOOT: The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use. |
| FG001 | Control Group | The attention control group will watch a show or listen to a podcast for the same time duration as the intervention sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief Counseling Intervention | REBOOT: The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Overdose Events | Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records. | Posted | Median | Inter-Quartile Range | overdoses | 16 Months |
|
16 months
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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 | Brief Counseling Intervention | REBOOT: The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heart failure | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| leg swelling | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Coffin, MD, MIA | San Francisco Department of Public Health, University fo California San Francisco | 628-217-6282 | phillip.coffin@sfdph.org |
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| 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 | May 10, 2023 | Mar 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D062787 | Drug Overdose |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| Boston |
| Massachusetts |
| 02118 |
| United States |
| McMahan VM, Arenander J, Matheson T, Lambert AM, Brennan S, Green TC, Walley AY, Coffin PO. "There's No Heroin Around Anymore. It's All Fentanyl." Adaptation of an Opioid Overdose Prevention Counseling Approach to Address Fentanyl Overdose: Formative Study. JMIR Form Res. 2022 Sep 7;6(9):e37483. doi: 10.2196/37483. |
| BG001 | Control Group | Participants in the control group will watch a show or listen to a podcast for the same amount of time as an intervention session as an attention control. |
| 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 | Count of Participants | Participants |
|
|
|
| 4 |
| 133 |
| 88 |
| 133 |
| 69 |
| 133 |
| EG001 | Control Group | Participants in the control group will watch a show or listen to a podcast for the same amount of time as an intervention session as an attention control. | 4 | 135 | 78 | 135 | 60 | 135 |
| heart attack | Cardiac disorders | Systematic Assessment |
|
| hernia | Gastrointestinal disorders | Systematic Assessment |
|
| norovirus | Gastrointestinal disorders | Systematic Assessment |
|
| gallstone | Hepatobiliary disorders | Systematic Assessment |
|
| gallbladder infection | Hepatobiliary disorders | Systematic Assessment |
|
| adverse reaction to medication | Immune system disorders | Systematic Assessment |
|
| endocarditis | Infections and infestations | Systematic Assessment |
|
| muscle infection | Infections and infestations | Systematic Assessment |
|
| hand infection | Infections and infestations | Systematic Assessment |
|
| blood infection | Infections and infestations | Systematic Assessment |
|
| pneumonia | Infections and infestations | Systematic Assessment |
|
| upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| soft tissue infection | Infections and infestations | Systematic Assessment |
|
| UTI | Infections and infestations | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| abcess | Infections and infestations | Systematic Assessment |
|
| excessive sweating/fever | Infections and infestations | Systematic Assessment |
|
| car accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| head injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| broken wrist | Injury, poisoning and procedural complications | Systematic Assessment |
|
| physical assault | Injury, poisoning and procedural complications | Systematic Assessment |
|
| dislocated shoulder | Injury, poisoning and procedural complications | Systematic Assessment |
|
| blood poisoning and kidney failure | Injury, poisoning and procedural complications | Systematic Assessment |
|
| car accident | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| broken ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| back and shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| seizure | Nervous system disorders | Systematic Assessment |
|
| memory loss and headache | Nervous system disorders | Systematic Assessment |
|
| confusion, loss of balance, slurred speech | Nervous system disorders | Systematic Assessment |
|
| coma | Nervous system disorders | Systematic Assessment |
|
| suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| panic attack | Psychiatric disorders | Systematic Assessment |
|
| psych emergency | Psychiatric disorders | Systematic Assessment |
|
| depressive episode | Psychiatric disorders | Systematic Assessment |
|
| 5150 hold | Psychiatric disorders | Systematic Assessment |
|
| complications related to dialysis | Renal and urinary disorders | Systematic Assessment |
|
| kidney failure | Renal and urinary disorders | Systematic Assessment |
|
| bladder cancer | Renal and urinary disorders | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| wrist abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| cyst | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| abscess/cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| heart murmur | Cardiac disorders | Systematic Assessment |
|
| endocarditis | Cardiac disorders | Systematic Assessment |
|
| overdose | Cardiac disorders | Systematic Assessment |
|
| high blood sugar | Endocrine disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| GERD | Gastrointestinal disorders | Systematic Assessment |
|
| adverse reaction to medication | General disorders | Systematic Assessment |
|
| sepsis | Immune system disorders | Systematic Assessment |
|
| adverse reaction to medication | Immune system disorders | Systematic Assessment |
|
| strep throat | Infections and infestations | Systematic Assessment |
|
| tooth infection | Infections and infestations | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| fungal infection of blood | Infections and infestations | Systematic Assessment |
|
| food poisoning | Infections and infestations | Systematic Assessment |
|
| blood poisoning/sepsis | Infections and infestations | Systematic Assessment |
|
| blood infection | Infections and infestations | Systematic Assessment |
|
| soft tissue infection | Infections and infestations | Systematic Assessment |
|
| knee infection | Infections and infestations | Systematic Assessment |
|
| overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| car accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| stabbing | Injury, poisoning and procedural complications | Systematic Assessment |
|
| coma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| staph infection | Injury, poisoning and procedural complications | Systematic Assessment |
|
| brain bruise | Injury, poisoning and procedural complications | Systematic Assessment |
|
| withdrawal symptoms | Injury, poisoning and procedural complications | Systematic Assessment |
|
| stimulant overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| death, suspected overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| adverse reaction to medication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| back and hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| foot pain and swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| physical assault | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| staph infection, rhabdomyolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| spinal fractures | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| head injury | Nervous system disorders | Systematic Assessment |
|
| confusion/disorientation | Nervous system disorders | Systematic Assessment |
|
| seizure | Nervous system disorders | Systematic Assessment |
|
| stroke | Nervous system disorders | Systematic Assessment |
|
| loss of consciousness | Nervous system disorders | Systematic Assessment |
|
| high risk pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| mental health crisis | Psychiatric disorders | Systematic Assessment |
|
| psych emergency | Psychiatric disorders | Systematic Assessment |
|
| inpatient psych hold | Psychiatric disorders | Systematic Assessment |
|
| kidney stone | Renal and urinary disorders | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| low oxygen | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| chest pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| staph infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| leg infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| foot infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| abscess/cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| thigh abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| neck abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| sepsis/cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| thumb blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| arm infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| hysterectomy | Surgical and medical procedures | Systematic Assessment |
|
| dizziness | Cardiac disorders | Systematic Assessment |
|
| heart murmur | Cardiac disorders | Systematic Assessment |
|
| ulcers | Gastrointestinal disorders | Systematic Assessment |
|
| GI lesions/ulcers | Gastrointestinal disorders | Systematic Assessment |
|
| ulcerative colitis | Gastrointestinal disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| Hepatitis C infection | Infections and infestations | Systematic Assessment |
|
| spinal infection | Infections and infestations | Systematic Assessment |
|
| UTI | Infections and infestations | Systematic Assessment |
|
| flu | Infections and infestations | Systematic Assessment |
|
| toe infection | Infections and infestations | Systematic Assessment |
|
| stomach flu | Infections and infestations | Systematic Assessment |
|
| testicle infection | Infections and infestations | Systematic Assessment |
|
| infection | Infections and infestations | Systematic Assessment |
|
| knee injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| back injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| shoulder injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| head injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| broken wrist | Injury, poisoning and procedural complications | Systematic Assessment |
|
| blood clots | Injury, poisoning and procedural complications | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| broken thumb | Injury, poisoning and procedural complications | Systematic Assessment |
|
| physical assault | Injury, poisoning and procedural complications | Systematic Assessment |
|
| dislocated shoulder | Injury, poisoning and procedural complications | Systematic Assessment |
|
| unintentional weight loss | Metabolism and nutrition disorders | Systematic Assessment |
|
| scoliosis worsening | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| painful sciatic nerve | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| arthritis in feet | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| broken finger | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| losing control of hand | Nervous system disorders | Systematic Assessment |
|
| pain, loss of sensation on right side of body | Nervous system disorders | Systematic Assessment |
|
| neurological changes s/p stroke | Nervous system disorders | Systematic Assessment |
|
| seizure | Nervous system disorders | Systematic Assessment |
|
| insomnia | Psychiatric disorders | Systematic Assessment |
|
| ED visit (unspecified) | Psychiatric disorders | Systematic Assessment |
|
| congestion and cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| chest discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| difficulty breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| MRSA infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| herpes | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| sublocade injection reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| leg wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| leg swelling | Blood and lymphatic system disorders | Systematic Assessment |
|
| stomach/bowel issue | Gastrointestinal disorders | Systematic Assessment |
|
| ulcerative colitis | Gastrointestinal disorders | Systematic Assessment |
|
| colon pain | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| withdrawal symptoms | Gastrointestinal disorders | Systematic Assessment |
|
| soreness due to dental work | General disorders | Systematic Assessment |
|
| withdrawal symptoms | General disorders | Systematic Assessment |
|
| allergic reaction | Immune system disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| stomach virus | Infections and infestations | Systematic Assessment |
|
| orchitis | Infections and infestations | Systematic Assessment |
|
| chlamydia | Infections and infestations | Systematic Assessment |
|
| HIV | Infections and infestations | Systematic Assessment |
|
| bacterial infection | Infections and infestations | Systematic Assessment |
|
| tooth pain | Infections and infestations | Systematic Assessment |
|
| overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| bike accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| car accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| injury due to physical assault | Injury, poisoning and procedural complications | Systematic Assessment |
|
| headache due to physical assault | Injury, poisoning and procedural complications | Systematic Assessment |
|
| sprained ankle | Injury, poisoning and procedural complications | Systematic Assessment |
|
| burn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| knee injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| injury from fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| pulled muscle | Injury, poisoning and procedural complications | Systematic Assessment |
|
| lost teeth due to injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| dog bite | Injury, poisoning and procedural complications | Systematic Assessment |
|
| knife injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| broken foot | Injury, poisoning and procedural complications | Systematic Assessment |
|
| hand injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| physical assault | Injury, poisoning and procedural complications | Systematic Assessment |
|
| unintentional weight gain | Metabolism and nutrition disorders | Systematic Assessment |
|
| unintentional weight loss | Metabolism and nutrition disorders | Systematic Assessment |
|
| broken cast | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| hip pain/arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| nervous twitching | Nervous system disorders | Systematic Assessment |
|
| anxiety attack | Psychiatric disorders | Systematic Assessment |
|
| painful menstruation | Reproductive system and breast disorders | Systematic Assessment |
|
| cervical polyp | Reproductive system and breast disorders | Systematic Assessment |
|
| HPV infection | Reproductive system and breast disorders | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| chest pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| lump in neck | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| swollen feet | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| rash/lesions | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| wound due to injection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| leg infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| swollen eye | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| blood infection/abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| needle stick | Social circumstances | Systematic Assessment |
|
| blood clot | Vascular disorders | Systematic Assessment |
|
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| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |