Cardiac Surgery Peer Recovery Support Program

December 10, 2019 updated by: David Goede, University of Rochester

The purpose of the study is to develop and implement an addiction recovery support program for cardiac surgery patients admitted with a diagnosis of infective endocarditis secondary to IV drug addiction.

This is a single center/single unit (7-3600) exploratory study to examine the efficacy of three interventions on a subject's SOCRATES 8D score at time of discharge, at three months, and at six months. A convenience sample of all patients admitted to 7-3600 who meet the inclusion criteria for this study will be approached and provided information related to this study. Once entered into the study, the subjects will continue in the study through their hospitalizations and up to 60 days post hospitalization.

This is a quality improvement study designed specifically for the cardiac surgery population. The unit is the primary unit that subjects who are admitted with IE are located. The study's objectives include:

By date of discharge, subjects enrolled in the Peer Recovery Support Program will:

  1. Actively engage in the program as defined by meeting with a Peer Support Volunteer at least two times prior to discharge, and or use of resilience journal, and or review of NA book.
  2. Demonstrate negative drug screens done randomly during their hospitalization.
  3. Actively contact at least one outpatient recovery program that they might enroll in prior to discharge (information about recovery programs to be provided by unit SW).
  4. Demonstrate appropriate changes in their SOCRATES 8D survey scores from admission to program to post discharge.
  5. Participate in follow up phone call with completion of SOCRATES 8D survey at 30 and 60 days post discharge.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In 2015, Cardiac Surgery service at the University of Rochester Medical Center surgically treated 33 patients with IE. Of these 33, 12 patients had a history of IV drug use prior to their admission. Five patients had recent IV drug use which is defined as use less than 30 days prior to admission. In 2016, Cardiac Surgery service surgically treated 41 patients with endocarditis. Of these 41, 20 patients had a history of recent IV drug use prior to their admission. Nine patients had recent IVDU. In 2017, IE admissions did decrease, 16 patients with IE were surgically treated. Of these, 6 patients had recent IVDU prior to admission (Figure 3) (P. Krause, personal communication, 12/20/2017). These numbers only represent the patients that had undergone surgical repair/replacement of their cardiac valves and thus do not include the patients that were admitted to the cardiac surgery service, medically managed, and then transferred or discharged to home.

The investigators do not have a total number of target subjects due to the variability of admissions with IE. The goal is to have at least 10 subjects enrolled and complete all follow ups.

  1. Inclusion Criteria:

    All patients considered for this program must meet the following criteria:

    1. Must be at least 18 years of age and able to provide consent
    2. Must speak/read/understand English
    3. Currently hospitalized and physically located on 7-3600 unit
    4. Followed by or on the Cardiac Surgery service
    5. Have a diagnosis of Endocarditis associated with recent or remote intravenous drug use (IVDU)
    6. Alert and oriented to person, place, time, and events leading up to hospitalization
    7. Able to carry on a coherent conversation
    8. Clinical Opiate Withdrawal (COW) score of less than or equal to 5 with no adjunctive (opioids) medication use within past 24 hours a. If COW score is greater than five or adjunctive medications have been used within the previous 24 hours, the patient will be re-evaluate every 24 hours until score is less than or equal to five and no adjunctive medications used within the previous 24 hours

  2. Exclusion Criteria:

    1. Under the age of 18 years old
    2. Unable to speak/read/understand English
    3. Hospitalized but not on 7-3600
    4. Does not have a diagnosis of endocarditis associated with IVDU
    5. Not followed by or on the Cardiac Surgery service
    6. Not Alert or oriented or unable to carry on a coherent conversation
    7. COW score that is greater than five or adjunctive medications have been used within the previous 24 hours (see inclusion criteria)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All patients considered for this program must meet the following criteria:

  1. Must be at least 18 years of age and able to provide consent
  2. Must speak/read/understand English
  3. Currently hospitalized and physically located on 7-3600 unit
  4. Followed by or on the Cardiac Surgery service
  5. Have a diagnosis of Endocarditis associated with recent or remote intravenous drug use (IVDU)
  6. Alert and oriented to person, place, time, and events leading up to hospitalization
  7. Able to carry on a coherent conversation
  8. Clinical Opiate Withdrawal (COW) score of less than or equal to 5 with no adjunctive (opioids) medication use within past 24 hours a. If COW score is greater than five or adjunctive medications have been used within the previous 24 hours, the patient will be re-evaluate every 24 hours until score is less than or equal to five and no adjunctive medications used within the previous 24 hours

Exclusion Criteria:

  1. Under the age of 18 years old
  2. Unable to speak/read/understand English
  3. Hospitalized but not on 7-3600
  4. Does not have a diagnosis of endocarditis associated with IVDU
  5. Not followed by or on the Cardiac Surgery service
  6. Not Alert or oriented or unable to carry on a coherent conversation
  7. COW score that is greater than five or adjunctive medications have been used within the previous 24 hours (see inclusion criteria)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peer Recovery Support Program

Patients enrolled in the Peer Recovery Support Program will:

  1. Actively engage in the program as defined by meeting with a Peer Support Volunteer at least two times prior to discharge, and or use of resilience journal, and or review of NA book.
  2. Demonstrate negative drug screens done randomly during their hospitalization.
  3. Actively contact at least one outpatient recovery program that they might enroll in prior to discharge (information about recovery programs to be provided by unit SW).
  4. Demonstrate appropriate changes in their SOCRATES 8D survey scores from admission to program to post discharge.
  5. Participate in follow up phone call with completion of SOCRATES 8D survey at 30 and 60 days post discharge.
Behavioral: Peer Recovery Support Program
See above

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SOCRATES 8D
Time Frame: 60 days post-discharge
Personal Drug Use Questionnaire
60 days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Goede, DNP ACNP-BC, University of Rochester School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SON2018-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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