Secondary Prevention and Recidivism Reduction in Trauma Patients
Primary Purpose
Trauma, Alcohol Use, Unspecified, Drug Use
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Brief Motivational Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Trauma
Eligibility Criteria
Inclusion Criteria:
- Sever trauma patients defined as the need of assistance in a critical unit.
- Positive screening for alcohol o other drugs (cannabis, cocaine, methamphetamine).
Exclusion Criteria:
- Patients in treatment for abuse of alcohol and other drugs.
- Death during hospitalization.
- Non Catalonia residents.
- Not Spanish or Catalan spoken.
Sites / Locations
- Corporacion Sanitaria Parc Taulí
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Recurrence of traumatisms
Any medical assistance related to a traumatism
Secondary Outcome Measures
Alcohol prevalence
Alcohol prevalence among trauma patients
Other drugs prevalence (cannabis, cocaine, methamphetamine)
Other drugs prevalence among trauma patients
Time to a recurrence
Time since discharge until the first new trauma or withdrawal from follow-up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03967262
Brief Title
Secondary Prevention and Recidivism Reduction in Trauma Patients
Official Title
Secondary Prevention and Recidivism Reduction in Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The consumption of alcohol and other drugs is one of the main risk factors for traumatism. In addition, patients who have suffered an accident in relation to the consumption of these substances present a high risk of recidivism. In the case of alcohol, its relationship with traumatisms has been known for many years now and is still one of the main risk factors.
Secondary prevention is an important area of action and improvement in the treatment of this type of patient by considering actions, such as a brief motivational intervention, in order to avoid recidivism. The objective of motivational intervention is to make the patient aware of the relationship between the consumption of these substances and the accident, and induce them to carry out a change in habits.
The objective of the present investigation project is to determine the efficacy of secondary prevention in reducing recurrence of traumatisms. In order to this, a multicenter randomised controlled trial has been designed in which the intervention group with patients admitted for sever traumatism with positive screening for alcohol or other drugs, will be submitted to a brief motivational intervention. The main outcome will be trauma recurrence within a three year follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Alcohol Use, Unspecified, Drug Use
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Intervention
Intervention Description
The objective of motivational intervention is to make the patient aware of the relationship between the consumption of alcohol and other drugs and the accident, and induce them to carry out a change in habits.
Primary Outcome Measure Information:
Title
Recurrence of traumatisms
Description
Any medical assistance related to a traumatism
Time Frame
Follow-up of 3 years
Secondary Outcome Measure Information:
Title
Alcohol prevalence
Description
Alcohol prevalence among trauma patients
Time Frame
Trough study completion, an average of 2 years
Title
Other drugs prevalence (cannabis, cocaine, methamphetamine)
Description
Other drugs prevalence among trauma patients
Time Frame
Trough study completion, an average of 2 years
Title
Time to a recurrence
Description
Time since discharge until the first new trauma or withdrawal from follow-up.
Time Frame
Trough study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sever trauma patients defined as the need of assistance in a critical unit.
Positive screening for alcohol o other drugs (cannabis, cocaine, methamphetamine).
Exclusion Criteria:
Patients in treatment for abuse of alcohol and other drugs.
Death during hospitalization.
Non Catalonia residents.
Not Spanish or Catalan spoken.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oriol Pino-Perez, MD
Phone
+34676607948
Email
oriol.pino@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Salvador Navarro-Soto, PhD
Email
snavarro@tauli.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvador Navarro-Soto, PhD
Organizational Affiliation
Corporacion Sanitaria Parc Tauli
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salvador Navarro-Soto, PhD
Organizational Affiliation
Corporacion Sanitaria Parc Tauli
Official's Role
Study Director
Facility Information:
Facility Name
Corporacion Sanitaria Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oriol Pino Pérez, MD
Phone
+34676607948
Email
oriol.pino@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Secondary Prevention and Recidivism Reduction in Trauma Patients
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