Secondary Prevention and Recidivism Reduction in Trauma Patients

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: Trauma; Drug Use; Alcohol Use, Unspecified
• Intervention / Treatment: Behavioral: Brief Motivational Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacion Sanitaria Parc Tauli

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Any medical assistance related to a traumatism	Follow-up of 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: Salvador Navarro-Soto, PhD, Corporacion Sanitaria Parc Tauli; Study Director: Salvador Navarro-Soto, PhD, Corporacion Sanitaria Parc Tauli

Study record dates

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: Wounds and Injuries
• 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