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Preventing Premature Death in Patients With Serious Opioid-related Infection

Primary Purpose

Opioid Use

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

brief motivational intervention (BMI)

cognitive behavioral therapy

About this trial

This is an interventional supportive care trial for Opioid Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Rochester Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of participants who completed the week 4 follow up assessments

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

Percentage of participants who report intervention acceptability

Written and verbal feedback will be collected from participants.

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.

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT03999450

First Posted

June 5, 2019

Last Updated

July 26, 2020

Sponsor

University of Rochester

Collaborators

National Center for Advancing Translational Sciences (NCATS)

1. Study Identification

Unique Protocol Identification Number

NCT03999450

Brief Title

Preventing Premature Death in Patients With Serious Opioid-related Infection

Official Title

Preventing Premature Death Among Hospital Patients With Serious Opioid-Related Infection (SORI): A Phase 1 Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

October 8, 2019 (Actual)

Primary Completion Date

May 31, 2020 (Actual)

Study Completion Date

May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Use

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Behavioral intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

brief motivational intervention (BMI)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

cognitive behavioral therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of participants who completed the week 4 follow up assessments

Description

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

Time Frame

week 4

Title

Percentage of participants who report intervention acceptability

Description

Written and verbal feedback will be collected from participants.

Time Frame

week 4

Title

Change in mean readiness

Description

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.

Time Frame

baseline to 2 weeks

Title

Change in mean self-regulation

Description

Time Frame

baseline to 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Preventing Premature Death in Patients With Serious Opioid-related Infection

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