Secondary Prevention and Recidivism Reduction in Trauma Patients

January 24, 2020 updated by: Salvador Navarro-Soto, Corporacion Parc Tauli

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporación Sanitaria Parc Taulí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Brief Motivational Intervention
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.
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of traumatisms
Time Frame: Follow-up of 3 years
Any medical assistance related to a traumatism
Follow-up of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol prevalence
Time Frame: Trough study completion, an average of 2 years
Alcohol prevalence among trauma patients
Trough study completion, an average of 2 years
Other drugs prevalence (cannabis, cocaine, methamphetamine)
Time Frame: Trough study completion, an average of 2 years
Other drugs prevalence among trauma patients
Trough study completion, an average of 2 years
Time to a recurrence
Time Frame: Trough study completion, an average of 2 years
Time since discharge until the first new trauma or withdrawal from follow-up.
Trough study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Salvador Navarro-Soto, PhD, Corporación Sanitaria Parc Taulí
  • Study Director: Salvador Navarro-Soto, PhD, Corporación Sanitaria Parc Taulí

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

May 26, 2019

First Submitted That Met QC Criteria

May 26, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPT-CG-PPT2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe