Clinical trial NCT05300581: Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids
Official title: Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with a history of injection drug use are historically excluded from home outpatient parenteral antibiotic therapy programs. Recent small pilot programs have demonstrated that these patients may be safely included in home OPAT programs when they are provided with medications for opioid use disorder such as suboxone or methadone. However nothing is known about the effect of additional social support services including case management and health coach navigation on the feasibility and acceptibility of home OPAT programs for persons who inject drugs. This observational study will provide pilot data on the feasibility of such a program in anticipation of a larger scale trial.


Eligibility criteria: Inclusion Criteria:

* English speaking males and females
* 18-100 years of age
* Being considered for discharge from Barnes-Jewish Hospital on OPAT\* (PICC/Midline only) for a serious injection related infection including; endocarditis, osteomyelitis, discitis, septic arthritis, epidural abscess, or S. aureus bacteremia. \*Note that outside of this protocol patients with a history of substance use disorder are considered for discharge on OPAT to skilled nursing facilities or other health-care locations such as BJH extended care. Patients being considered for discharge on OPAT to any of these locations are eligible for inclusion.
* History of injection opioid use within the last 1 year
* Evaluated by the joint toxicology/psychiatry addiction medicine consult service during the current inpatient admission
* Started or maintained on medications for opioid use disorder (MOUD) of either methadone, buprenorphine or buprenorphine-naloxone during admission to Barnes-Jewish Hospital
* Have a scheduled follow-up for continuation of medications for opioid use disorder in place prior to discharge. For patients on methadone this should include a scheduled appointment at a methadone clinic, or for patients on buprenorphine this can include a plan for ongoing buprenorphine/ buprenorphine-naloxone based therapy at the Washington University Infectious Diseases Clinic.
* Have met with a health coach or a member of the Bridge To Health team during their inpatient hospitalization and agree to ongoing supportive counseling after discharge.
* Be willing and able to attend in-person clinic visits within 60 days post-discharge at the Washington University Infectious Diseases Clinic.
* Have a working phone number with active voicemail, running water and electricity.

Exclusion Criteria:

* Prisoner status
* Unable to provide own informed consent
* Current homelessness
* Other house-hold members reported as having active untreated substance use disorders
* Unable to attend outpatient appointments. This may include patients who are from rural areas where transportation vouchers may not provide sufficient means of making it to follow-up appointments, or other disability that would preclude transportation (paralysis, broken limbs) where the patient is unable to provide specific details as to how they would arrive at clinic appointments.

Primary outcomes:
measure: Completion of parenteral antibiotic therapy
timeFrame: 6 weeks patient participation
measure: Illicit drug use
timeFrame: 6 weeks patient participation
Secondary outcomes:
measure: Survey Completion
timeFrame: 3 month chart review
measure: 90-day microbiologic failure
timeFrame: 3 month chart review
measure: 90-day Overdose
timeFrame: 3 month chart review
measure: Sample Size Estimation for Future Study
timeFrame: One year post-enrollment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington Univeristy
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Laura Marks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: