Preventing Premature Death in Patients With Serious Opioid-related Infection

NCT03999450 | Completed

• 1 other identifier: RSRB00003696
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (4)

• Percentage of participants who completed the week 4 follow up assessments

  The percentage of participants who completed the week 4 follow up assessments.

  week 4

• Percentage of participants who report intervention acceptability

  Written and verbal feedback will be collected from participants.

  week 4

• Change in mean readiness

  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.

  baseline to 2 weeks

• Change in mean self-regulation

  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)

  baseline to 2 weeks

Study Arms (1)

Behavioral intervention

EXPERIMENTAL

Patients admitted to Strong Hospital with opioid use will be given 1 to 3 brief motivational interventions and computer based cognitive behavioral therapy

Behavioral: brief motivational intervention (BMI); Behavioral: cognitive behavioral therapy

Interventions

brief motivational intervention (BMI) BEHAVIORAL

The intervention typically takes 45 minutes to administer and is designed to enhance motivation to change and includes the following components: establishing rapport, asking permission to discuss substance use and providing feedback regarding the substance use assessment, exploring personal consequences of drug use, eliciting the gap between real and desired quality of life, and discussing readiness to change. The therapist then negotiates a written action plan, during which the subject is supported with empathy and verbal reinforcement.

Behavioral intervention

cognitive behavioral therapy BEHAVIORAL

This evidence-based, online, Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) program covers six lessons: 1) changing patterns of use, 2) coping with craving, 3) refusing drugs, 4) problem-solving skills, 5) changing drug-related thoughts, and 6) improving decision-making. The program is designed to be user-friendly and includes videotaped instructions and examples, interactive assessments, and practice exercises.

Behavioral intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 26, 2019
• Study Start: October 8, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

US (1)