Cardiac Surgery Peer Support Recovery

Substance Use Disorders Clinical Trial

Official title:

Cardiac Surgery Peer Recovery Support Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03642379
• Other study ID #: Peer Recovery Support
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: September 10, 2019

Study information

• Verified date: October 2018
• Source: University of Rochester
• Contact: David S Goede, DNP
• Phone: 585-275-5276
• Email: david_goede[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Develop and implementation an addiction recovery support program for cardiac surgery patients admitted with a diagnosis of infective endocarditis secondary to IV drug addiction.

Description:

Patients admitted with active IE secondary to IV drug use require a myriad of services and will remain hospitalized for a minimum of six weeks. During their hospitalization, infectious disease service assists in developing a treatment plan for the active infection, neurosurgery service evaluates and develops a plan to treat any sequelae of endocarditis, toxicology service develops a treatment plan to manage the detoxification, and cardiac surgery service develops a treatment plan for the infected valve. In spite of all these services, there is no dedicated service to address the patient's substance use disorder (SUD). This missed opportunity to begin addressing the substance use disorder potentially impairs the patient's ability to engage in the first steps towards sobriety. Ideally, a recovery support model of care would be available to assist these patients during their hospitalization to transition from active addiction into the early phases of recovery from 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 90 days post hospitalization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis
• IV Drug Usage
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Peer Advocate
Provide NA book to review during hospitalization

Locations

Country	Name	City	State
United States	University of Rochester Medical Center Strong Memorial Hospital	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Abstinence from drug use based on negative drug screen	Demonstrate negative drug screens done randomly by urine testing during their hospitalization.	Enrollment up to 60 days post-discharge
Other	Engagement in the Peer Recovery Support Program	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 Narcotics Anonymous book	Count of number of meetings in 2 weeks
Other	Planning for outpatient recovery program	Actively contact at least one outpatient recovery program that they might enroll in by study completion (information about recovery programs to be provided by unit SW).	1 week prior to discharge
Primary	Readiness to change	Personal Drug Use Questionnaire SOCRATES 8D survey scores from admission to program to post discharge. A 19 item scale that measures 3 domains, Recognition of a drug problem, Ambivalence to change, and Taking Steps towards recovery. Each item is measured on a 5 point Likert scale. Scoring on the domains indicates the individual readiness to pursue sobriety. Score range for Recognition is 7-35. High score (35) correlates that they do identify they have a problem related to substance use while a low score (<30) indicates denial of a problem. The Ambivalence score range is between 4-20. A high score (>17) on this domain indicates ambivalence or uncertainty of change while a low score (<8) indicates that they do know that they have a drinking problem. Taking Steps score range is between 8-40. High scores (>36) in this domain indicate that the individual is taking steps on to change their behavior while low scores (<30) indicate that they are not currently doing things to change	Change in scores from end of intervention (2 weeks) to 30, 60, and 90 days post-intervention
Secondary	Participation in peer recovery support program	Participate in follow up phone call with completion of SOCRATES 8D survey at 30, 60 and 90 days post discharge	Change in scores from end of intervention (2 weeks) to 30, 60, 90 days post-intervention