IV Drug UsageNCT03590106
Cardiac Surgery Peer Recovery Support Program
A study testing Peer Recovery Support Program in people with IV Drug Usage and Infective Endocarditis, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IV Drug Usage, Infective Endocarditis, Substance Use Disorders
- What is being tested?
- Peer Recovery Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2018to 7 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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.
Read more
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.
Read the 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)
- Being tested
- Peer Recovery Support Program
- Medical subject headings
- Endocarditis, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Recovery Support ProgramBehavioural
See above
| Study group | Role | What they receive |
|---|---|---|
| Peer Recovery Support Program | Experimental | 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. Receives: Behavioral: Peer Recovery Support Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOCRATES 8D
Personal Drug Use Questionnaire
Measured: 60 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start3 Sep 2018
- Primary completion7 Oct 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IV Drug UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Goede, University of Rochester
- Investigators
- David Goede, DNP ACNP-BC, Principal investigator, University of Rochester School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590106
- Sponsor's protocol ID
- SON2018-001
- Status last verified
- Dec 2019
- First submitted
- 5 Jul 2018
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Surgery Peer Recovery Support Program
- ClinicalTrials.gov ID
- NCT03590106
- Acronym / sponsor ID
- SON2018-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Peer Recovery Support Program | Experimental | Behavioral: Peer Recovery Support ProgramPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Recovery Support ProgramSee above | Behavioural | Peer Recovery Support Program |
Primary outcome
SOCRATES 8D
Time frame: 60 days post-discharge
Personal Drug Use Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Goede, DNP ACNP-BC principal investigator
University of Rochester School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Recovery Support Program in people with IV Drug Usage and Infective Endocarditis, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOCRATES 8D (time frame: 60 days post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.