Preventing Premature Death in Patients With Serious Opioid-related Infection

Not Applicable

Completed

• Conditions: Opioid Use
• Interventions: Behavioral: brief motivational intervention (BMI); Behavioral: cognitive behavioral therapy

• Registration Number: NCT03999450
• Lead Sponsor: University of Rochester

Brief Summary

The purpose of this study is to test the efficacy of a combination of motivational interventions and a brief therapy session to increase the adherence to medication-assisted treatment (MAT) for opioids.

Detailed Description

We will recruit 30 SORI inpatients ages 18-plus admitted to the University of Rochester Medical Center (URMC). We will administer a battery of validated assessments of substance use, overdose history and risk, opioid-related infection, and suicidal behavior at baseline and approximately 2- and 4-week follow-ups. We will assess both forms of overdose (unintentional, intentional - i.e., suicidal behavior) because each is common in intravenous drug users and they require systematic assessment to disentangle. All recruited individuals will receive one-to-three MI sessions as they begin the MAT that is part of standard hospital care. Patients will be offered computer-based CBT, which they will complete on the unit at their convenience. The CBT program records duration of use of the treatment modules, enabling us to track patients' level of CBT treatment participation. Patient-completed intervention feedback forms and treatment completion will be examined after 15 subjects have participated. Based on this feedback, we will pilot an adapted (MI plus CBT) treatment manual, obtaining additional feedback on acceptability. We will assess psychopathy, a constellation of stable traits and potentially important moderator of treatment effects, at baseline. We will assess potential mediators (i.e., motivation to change, self-regulation) using validated measures at baseline and at approximately 2- and 4-weeks post-discharge.

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-26
• Study Start: 2019-10-08
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-26
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Age 18 or older
• Willing to provide contact information (e.g., email, phone, address)
• Presence of SORI, including endocarditis, osteomyelitis, septic arthritis, epidural abscess, or serious bacteremia
• Hospital length of stay estimated at > 3 weeks
• Admitted to URMC and seen by the Toxicology Consult Team. Providers will be informed of inclusion/exclusion requirements so that they can make an informed decision about whether a patient may be approached.

Exclusion Criteria

• Non-English speaking
• Unwilling to provide informed consent; unable to provide informed consent or participate in study procedures due to lack of comprehension, medical barriers (e.g., intubated), or behavioral (e.g., violence) or severe psychiatric problems (e.g., florid psychosis). Capacity to provide informed consent will be determined by their treatment team or other provider consult team as appropriate. This serves a dual function of both basing consent capacity on the most accurate and current medical information, as well as keeping their treatment team informed of any research involvement of their patient.
• Note that patients may be ineligible initially but become eligible due to stabilization during hospitalization, at which point we would then proceed as usual with the identification and recruitment process. We will seek to recruit every SORI admission who meets eligibility criteria within the recruitment timeframe.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral intervention	cognitive behavioral therapy	Patients admitted to Strong Hospital with opioid use will be given 1 to 3 brief motivational interventions and computer based cognitive behavioral therapy
Behavioral intervention	brief motivational intervention (BMI)	Patients admitted to Strong Hospital with opioid use will be given 1 to 3 brief motivational interventions and computer based cognitive behavioral therapy

Primary Outcome Measures

Name	Time	Method
Percentage of participants who report intervention acceptability	week 4	Written and verbal feedback will be collected from participants.
Change in mean readiness	baseline to 2 weeks	A readiness ruler with a scale of 1- 10 where higher numbers indicate better health outcomes will be used to to assess motivation to change illicit substance use.
Change in mean self-regulation	baseline to 2 weeks	The Self-Regulation Questionnaire is a 63 item questionnaire with each question rated at a 5-point likert scale.; \> 239 High (intact) self-regulation capacity (top quartile) 214-238 Intermediate (moderate) self-regulation capacity (middle quartiles) \< 213 Low (impaired) self-regulation capacity (bottom quartile)
Percentage of participants who completed the week 4 follow up assessments	week 4	The percentage of participants who completed the week 4 follow up assessments.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States