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Cardiac Surgery Peer Recovery Support Program

Primary Purpose

IV Drug Usage, Infective Endocarditis, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Recovery Support Program
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for IV Drug Usage

Eligibility Criteria

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

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)

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peer Recovery Support Program

Arm Description

Patients enrolled in the Peer Recovery Support Program will: 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. Demonstrate negative drug screens done randomly during their hospitalization. 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). Demonstrate appropriate changes in their SOCRATES 8D survey scores from admission to program to post discharge. Participate in follow up phone call with completion of SOCRATES 8D survey at 30 and 60 days post discharge.

Outcomes

Primary Outcome Measures

SOCRATES 8D
Personal Drug Use Questionnaire

Secondary Outcome Measures

Full Information

First Posted
July 5, 2018
Last Updated
December 10, 2019
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT03590106
Brief Title
Cardiac Surgery Peer Recovery Support Program
Official Title
Cardiac Surgery Peer Recovery Support Program
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
October 7, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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: 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. Demonstrate negative drug screens done randomly during their hospitalization. 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). Demonstrate appropriate changes in their SOCRATES 8D survey scores from admission to program to post discharge. Participate in follow up phone call with completion of SOCRATES 8D survey at 30 and 60 days post discharge.
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. Inclusion Criteria: All patients considered for this program must meet the following criteria: Must be at least 18 years of age and able to provide consent Must speak/read/understand English Currently hospitalized and physically located on 7-3600 unit Followed by or on the Cardiac Surgery service Have a diagnosis of Endocarditis associated with recent or remote intravenous drug use (IVDU) Alert and oriented to person, place, time, and events leading up to hospitalization Able to carry on a coherent conversation 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: Under the age of 18 years old Unable to speak/read/understand English Hospitalized but not on 7-3600 Does not have a diagnosis of endocarditis associated with IVDU Not followed by or on the Cardiac Surgery service Not Alert or oriented or unable to carry on a coherent conversation COW score that is greater than five or adjunctive medications have been used within the previous 24 hours (see inclusion criteria)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IV Drug Usage, Infective Endocarditis, Substance Use Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients meeting the eligibility criteria will be approached about participation in the Peer Recovery Support Program. Those who agree will receive the intervention as designed. Those who receive will continue to receive standard of care.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Recovery Support Program
Arm Type
Experimental
Arm Description
Patients enrolled in the Peer Recovery Support Program will: 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. Demonstrate negative drug screens done randomly during their hospitalization. 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). Demonstrate appropriate changes in their SOCRATES 8D survey scores from admission to program to post discharge. Participate in follow up phone call with completion of SOCRATES 8D survey at 30 and 60 days post discharge.
Intervention Type
Behavioral
Intervention Name(s)
Peer Recovery Support Program
Intervention Description
See above
Primary Outcome Measure Information:
Title
SOCRATES 8D
Description
Personal Drug Use Questionnaire
Time Frame
60 days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients considered for this program must meet the following criteria: Must be at least 18 years of age and able to provide consent Must speak/read/understand English Currently hospitalized and physically located on 7-3600 unit Followed by or on the Cardiac Surgery service Have a diagnosis of Endocarditis associated with recent or remote intravenous drug use (IVDU) Alert and oriented to person, place, time, and events leading up to hospitalization Able to carry on a coherent conversation 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: Under the age of 18 years old Unable to speak/read/understand English Hospitalized but not on 7-3600 Does not have a diagnosis of endocarditis associated with IVDU Not followed by or on the Cardiac Surgery service Not Alert or oriented or unable to carry on a coherent conversation COW score that is greater than five or adjunctive medications have been used within the previous 24 hours (see inclusion criteria)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Goede, DNP ACNP-BC
Organizational Affiliation
University of Rochester School of Nursing
Official's Role
Principal Investigator
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
No

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Cardiac Surgery Peer Recovery Support Program

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