Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04567381 |
| Other study ID # |
2018-165 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2018 |
| Est. completion date |
October 31, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Medstar Health Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 management over a one year period. Primary
outcome will be rate of violent reinjury after enrollment. Follow-up will be for one year.
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.
