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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03967262
Other study ID # CSPT-CG-PPT2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date October 1, 2022

Study information

Verified date January 2020
Source Corporacion Parc Tauli
Contact Oriol Pino-Perez, MD
Phone +34676607948
Email oriol.pino@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 102
Est. completion date October 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


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.

Locations

Country Name City State
Spain Corporacion Sanitaria Parc Taulí Sabadell Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence of traumatisms Any medical assistance related to a traumatism Follow-up of 3 years
Secondary Alcohol prevalence Alcohol prevalence among trauma patients Trough study completion, an average of 2 years
Secondary Other drugs prevalence (cannabis, cocaine, methamphetamine) Other drugs prevalence among trauma patients Trough study completion, an average of 2 years
Secondary 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
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