Secondary Prevention and Recidivism Reduction in Trauma Patients

NCT03967262 | Unknown

• 1 other identifier: CSPT-CG-PPT2
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Alcohol Use, Unspecified; Drug Use

Outcome Measures

Primary Outcomes (1)

• Recurrence of traumatisms

  Any medical assistance related to a traumatism

  Follow-up of 3 years

Secondary Outcomes (3)

• Alcohol prevalence

  Trough study completion, an average of 2 years

• Other drugs prevalence (cannabis, cocaine, methamphetamine)

  Trough study completion, an average of 2 years

• Time to a recurrence

  Trough study completion, an average of 2 years

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Brief Motivational Intervention

Control

NO INTERVENTION

Interventions

Brief Motivational Intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sever trauma patients defined as the need of assistance in a critical unit.
• Positive screening for alcohol o other drugs (cannabis, cocaine, methamphetamine).

You may not qualify if:

• Patients in treatment for abuse of alcohol and other drugs.
• Death during hospitalization.
• Non Catalonia residents.
• Not Spanish or Catalan spoken.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Corporacion Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries; Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Salvador Navarro-Soto, PhD

  Corporacion Sanitaria Parc Tauli

  PRINCIPAL INVESTIGATOR

• Salvador Navarro-Soto, PhD

  Corporacion Sanitaria Parc Tauli

  STUDY DIRECTOR

Central Study Contacts

Oriol Pino-Perez, MD

CONTACT

+34676607948; oriol.pino@gmail.com

Salvador Navarro-Soto, PhD

CONTACT

snavarro@tauli.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of General and Digestive Surgery Department

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: May 30, 2019
• Study Start: September 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

ES (1)