ViolenceNCT04567381
An Outcome Evaluation of the Project CHANGE-MS Violence Intervention Program
A study testing Enhanced Services and Treatment as Usual in people with Violence and Recidivism, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This is a prospective randomized control trial design to evaluate the effectiveness of a hospital based violence intervention program. Participants will be randomized into a "treatment as usual" group who will receive written referrals for services and an "enhanced services" group who will receive intensive case… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Violence, Recidivism
- What is being tested?
- Enhanced Services and Treatment as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 Oct 2021
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- identify as male
- be 18 years of age or older
- speak English
- have experienced a violent injury in the form of a gunshot wound, stabbing, or assault within two years of first contact with the program (verified through trauma registry)
- experienced the injury within the borders of the east coast city where the study is taking place.
Who cannot join
- identifying as female
- reporting an age ≤ 17
- experiencing a self-inflicted violent injury
- experiencing a traumatic brain injury
- being under police custody
- not being injured within the borders of the east coast city where the study is taking place
- not being able to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: An Evaluation of the Project CHANGE-MS Violence Intervention Program
This is a prospective randomized control trial design to evaluate the effectiveness of a hospital based violence intervention program. Participants will be randomized into a "treatment as usual" group who will receive written referrals for services and an "enhanced services" group who will receive intensive case management over a one year period. Primary outcome will be rate of violent reinjury after enrollment. Follow-up will be for one year.
Read the detailed description
Potential study participants are all adult, male survivors of community violence treated at the study site.
After a potential study participant is screened and deemed eligible for participation in the study consent will be obtained to participate in the study. At stage one a participant can either accept or refuse services and at stage two can consent or refuse to consent in the study.
If a patient consents to both receive services and participate in the study, the participant will be randomly assigned to either the "Treatment as Usual" (TAU) intervention, which receives the referral card for services, or the "Enhanced Treatment" (ET) intervention prior to assessment so that the results of the assessment do not influence program staff which group the potential study participant is assigned. At the beginning of the study, 400 identical envelopes will be created, 200 with a slip of paper labeled "Treatment as Usual" and 200 with a slip of paper labeled "Enhanced Treatment." These will be shuffled and will be used to assign the random group of those patients that consent to participate.
Those who refuse services and refuse the study will not be included in the study. Finally, those who accept services but refuse to be in the study will not be in the study.
Participation in the study will take place in five stages. At stage one, after consenting to the study and being randomly assigned to TAU or ET care groups, the patient will undergo an interview. The interview will take place at bedside granted that privacy can be guaranteed or in an office if the patient is mobile. In some cases it may be appropriate to set up an appointment after discharge to conduct the interview. Patients that agree to participate in the study will be entered into a secure Excel Database on a MedStar password protected server. Only study personnel will have access to this database, which will contain a key with patient name and a unique identifier. This database will also be used to assess study quality measures of approaches to eligible participants and percent uptake. This database and the signed consents will have identifiable patient information. An additional SpreadSheet Web tool, provided by the DC Department of Health Office of Victims Services and Justice Grants will be used to track outcomes and follow-up of participants. This will include only de-identified information. The internal secure Excel database will have a link between patient name and unique identifier.
At stage two, the participant engages the project depending on which group they are in. Those in the ET group will receive a case manager whereas those in the TAU group will receive a referral card. Those in the ET will receive case management services and receive information and other counseling services whereas those who receive the referral card will be expected to engage the services on the referral cards provided.
At stage three, the study participants will be asked to conduct a smaller interview at month 6 after entry into the program to determine subsequent injury. The results of this interview will be recorded in the DC DOH-OVSJG SpreadSheet Web tool. In addition, partnership with CRISP (Chesapeake Regional Information System for our Patients) will be used to actively query whether or not participants have been seen in regional hospitals, EDs, or outpatient settings for repeat violent injury.
CRISP is a regional health information system and is entirely HIPAA compliant and has health information level security. It has been designated as Maryland's statewide health information exchange. Under a contract with CRISP, each site will be able to securely submit the names of patients that have agreed to participate in research. CRISP will then send notifications of patient care and each site will be able to have accurate follow-up of the main outcome (recidivism). This will allow validation of answers from telephone interviews at 6 and 12 months as well as gain accurate information on those participants that may be lost to follow-up. Patient information is relayed securely using specially designed HIPAA and confidentiality compliant email addresses, created for this purpose. All participants will specifically be asked for their permission to access CRISP for this purpose.
At stage four, approximately twelve months after entry into the study, the study participants will be engaged in the post-interview. Answers to this post-interview will be recorded and tracked in the DC DOH OVSJG SpreadSheet Web de-identified database.
Stage five will entail an invitation to a focus group. Four focus groups will be conducted after the quantitative data collection. Two of the focus groups will focus on those who have not successfully completed the program and two more will randomly sample among those who have successfully completed the program. The four focus groups will have no more than seven individuals. Focus groups will be conducted in a private, unlabeled conference room at the hospital.
- Conditions
- Violence, Recidivism
- Being tested
- Enhanced Services, Treatment as Usual
- Keywords
- Violence prevention, Hospital based, Community Violence, Violent Recidivism
- Medical subject headings
- Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced ServicesOther
In enhanced services, the provision of services go beyond just referring a patient and leaving them to follow-through on their own accord. ES varies based on resources, model of service delivery, philosophy, and role and responsibilities of team members. Enhanced services usually includes longer-term case management which can then facilitate the connection to clinical counseling, victim assistance, familial assistance, legal assistance, emergency financial funding, transportation for subsequent appointments related to a patient's medical condition, employment assistance, and assistance in educational program enrollment.
Treatment as UsualOther
Individuals randomized to TAU will receive a list of resources which provides participants with community agency information that they can engage on their own. The list of resources will include contact information for various services such as housing, employment, mental health and legal services. Patients randomized into this condition receive little to no assistance from program staff and must navigate the vast terrain of social service providers on their own.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Treatment as Usual (TAU)/Control. Individuals randomized to TAU will receive a list of resources which provides participants with community agency information that they can engage on their own. The list of resources will include contact information for various services such as housing, employment, mental health and legal services. Patients randomized into this condition receive little to no assistance from program staff and must navigate the vast terrain of social service providers on their own. Receives: Other: Treatment as Usual |
| Enhanced Services | Experimental | Enhanced Services/Treatment (ES). Participants randomized to the ES intervention will receive intensive community-based case management. Receives: Other: Enhanced Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of violent reinjuries in 12 months
Subsequent violent reinjury
Measured: 12 months
Number of participants with death in 12 months
Death
Measured: 12 months
Secondary outcomes (6)
Decreased in Frequency of Substance Abuse in past-30 days
Substance Abuse in previous 30 days from survey
Measured: 12 months
Improvement of Level of Mastery as measured using Pearlin Mastery Scale
Extent one regards one's life-chances as being under one's own control
Measured: 12 months
Improvement in Disposition towards Violence as measured using the Code of the Street Scale
Extent to which it is justifiable or advantageous to use violence using Simon's Code of the Street
Measured: 12 months
Decrease in number of Medical Legal Needs screened positive
Number of screening civil medical legal needs
Measured: 12 months
Improved Life Satisfaction
Measured with the Satisfaction with Life Scale, a 7-point Likert scale questionnaire with minimum score of 5, maximum of 35
Measured: 12 months
Decreased Post-Traumatic Stress Disorder (PTSD) Symptoms measured using PTSD-8: A Short PTSD Inventory
measured using PTSD-8, an 8 question with 4-point Likert scale validated screening questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Aug 2018
- Primary completion31 Oct 2020
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized into two separate groups, treatment as usual and enhanced services. Groups will be followed concurrently for one year for the outcomes of interest.
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567381
- Sponsor's protocol ID
- 2018-165
- Status last verified
- Feb 2022
- First submitted
- 17 Sep 2020
- Last updated
- 14 Feb 2022
- 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 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Project CHANGE-MS Violence Intervention Program
- ClinicalTrials.gov ID
- NCT04567381
- Acronym / sponsor ID
- 2018-165
- Conditions
- Violence, Recidivism
- Keywords
- Violence prevention, Hospital based, Community Violence, Violent Recidivism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 28 Sep 2020 (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.
This is a prospective randomized control trial design to evaluate the effectiveness of a hospital based violence intervention program. Participants will be randomized into a "treatment as usual" group who will receive written referrals for services and an "enhanced services" group who will receive intensive case management over a one year period. Primary outcome will be rate of violent reinjury after enrollment. Follow-up will be for one year.
Detailed description
Potential study participants are all adult, male survivors of community violence treated at the study site.
After a potential study participant is screened and deemed eligible for participation in the study consent will be obtained to participate in the study. At stage one a participant can either accept or refuse services and at stage two can consent or refuse to consent in the study.
If a patient consents to both receive services and participate in the study, the participant will be randomly assigned to either the "Treatment as Usual" (TAU) intervention, which receives the referral card for services, or the "Enhanced Treatment" (ET) intervention prior to assessment so that the results of the assessment do not influence program staff which group the potential study participant is assigned. At the beginning of the study, 400 identical envelopes will be created, 200 with a slip of paper labeled "Treatment as Usual" and 200 with a slip of paper labeled "Enhanced Treatment." These will be shuffled and will be used to assign the random group of those patients that consent to participate.
Those who refuse services and refuse the study will not be included in the study. Finally, those who accept services but refuse to be in the study will not be in the study.
Participation in the study will take place in five stages. At stage one, after consenting to the study and being randomly assigned to TAU or ET care groups, the patient will undergo an interview. The interview will take place at bedside granted that privacy can be guaranteed or in an office if the patient is mobile. In some cases it may be appropriate to set up an appointment after discharge to conduct the interview. Patients that agree to participate in the study will be entered into a secure Excel Database on a MedStar password protected server. Only study personnel will have access to this database, which will contain a key with patient name and a unique identifier. This database will also be used to assess study quality measures of approaches to eligible participants and percent uptake. This database and the signed consents will have identifiable patient information. An additional SpreadSheet Web tool, provided by the DC Department of Health Office of Victims Services and Justice Grants will be used to track outcomes and follow-up of participants. This will include only de-identified information. The internal secure Excel database will have a link between patient name and unique identifier.
At stage two, the participant engages the project depending on which group they are in. Those in the ET group will receive a case manager whereas those in the TAU group will receive a referral card. Those in the ET will receive case management services and receive information and other counseling services whereas those who receive the referral card will be expected to engage the services on the referral cards provided.
At stage three, the study participants will be asked to conduct a smaller interview at month 6 after entry into the program to determine subsequent injury. The results of this interview will be recorded in the DC DOH-OVSJG SpreadSheet Web tool. In addition, partnership with CRISP (Chesapeake Regional Information System for our Patients) will be used to actively query whether or not participants have been seen in regional hospitals, EDs, or outpatient settings for repeat violent injury.
CRISP is a regional health information system and is entirely HIPAA compliant and has health information level security. It has been designated as Maryland's statewide health information exchange. Under a contract with CRISP, each site will be able to securely submit the names of patients that have agreed to participate in research. CRISP will then send notifications of patient care and each site will be able to have accurate follow-up of the main outcome (recidivism). This will allow validation of answers from telephone interviews at 6 and 12 months as well as gain accurate information on those participants that may be lost to follow-up. Patient information is relayed securely using specially designed HIPAA and confidentiality compliant email addresses, created for this purpose. All participants will specifically be asked for their permission to access CRISP for this purpose.
At stage four, approximately twelve months after entry into the study, the study participants will be engaged in the post-interview. Answers to this post-interview will be recorded and tracked in the DC DOH OVSJG SpreadSheet Web de-identified database.
Stage five will entail an invitation to a focus group. Four focus groups will be conducted after the quantitative data collection. Two of the focus groups will focus on those who have not successfully completed the program and two more will randomly sample among those who have successfully completed the program. The four focus groups will have no more than seven individuals. Focus groups will be conducted in a private, unlabeled conference room at the hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized into two separate groups, treatment as usual and enhanced services. Groups will be followed concurrently for one year for the outcomes of interest.
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Other: Treatment as UsualTreatment as Usual (TAU)/Control. Individuals randomized to TAU will receive a list of resources which provides participants with community agency information that they can engage on their own. The list of resources will include contact information for various services such as housing, employment, mental health and legal services. Patients randomized into this condition receive little to no assistance from program staff and must navigate the vast terrain of social service providers on their own. |
| Enhanced Services | Experimental | Other: Enhanced ServicesEnhanced Services/Treatment (ES). Participants randomized to the ES intervention will receive intensive community-based case management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- identify as male
- be 18 years of age or older
- speak English
- have experienced a violent injury in the form of a gunshot wound, stabbing, or assault within two years of first contact with the program (verified through trauma registry)
- experienced the injury within the borders of the east coast city where the study is taking place.
Key exclusion criteria (7 listed)
- identifying as female
- reporting an age ≤ 17
- experiencing a self-inflicted violent injury
- experiencing a traumatic brain injury
- being under police custody
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 |
|---|---|---|
| Enhanced ServicesIn enhanced services, the provision of services go beyond just referring a patient and leaving them to follow-through on their own accord. ES varies based on resources, model of service delivery, philosophy, and role and responsibilities of team members. Enhanced services usually includes longer-term case management which can then facilitate the connection to clinical counseling, victim assistance, familial assistance, legal assistance, emergency financial funding, transportation for subsequent appointments related to a patient's medical condition, employment assistance, and assistance in educational program enrollment. | Other | Enhanced Services |
| Treatment as UsualIndividuals randomized to TAU will receive a list of resources which provides participants with community agency information that they can engage on their own. The list of resources will include contact information for various services such as housing, employment, mental health and legal services. Patients randomized into this condition receive little to no assistance from program staff and must navigate the vast terrain of social service providers on their own. | Other | Treatment as Usual |
Primary outcome
Number of violent reinjuries in 12 months
Time frame: 12 months
Subsequent violent reinjury
Number of participants with death in 12 months
Time frame: 12 months
Death
6 secondary outcomes
Decreased in Frequency of Substance Abuse in past-30 days
Time frame: 12 months
Improvement of Level of Mastery as measured using Pearlin Mastery Scale
Time frame: 12 months
Improvement in Disposition towards Violence as measured using the Code of the Street Scale
Time frame: 12 months
Decrease in number of Medical Legal Needs screened positive
Time frame: 12 months
Improved Life Satisfaction
Time frame: 12 months
Decreased Post-Traumatic Stress Disorder (PTSD) Symptoms measured using PTSD-8: A Short PTSD Inventory
Time frame: 12 months
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 14 Feb 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Services and Treatment as Usual in people with Violence and Recidivism, run by Medstar Health Research Institute 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 5 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 14 Feb 2022. 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?
Number of violent reinjuries in 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 14 Feb 2022.