TraumaNCT03967262
Secondary Prevention and Recidivism Reduction in Trauma Patients
A study testing Brief Motivational Intervention in people with Trauma and Alcohol Use, Unspecified, run by Corporacion Parc Tauli at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Alcohol Use, Unspecified, Drug Use
- What is being tested?
- Brief Motivational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sever trauma patients defined as the need of assistance in a critical unit.
- Positive screening for alcohol o other drugs (cannabis, cocaine, methamphetamine).
Who cannot join
- Patients in treatment for abuse of alcohol and other drugs.
- Death during hospitalization.
- Non Catalonia residents.
- Not Spanish or Catalan spoken.
Trial locations and contacts
1 site in 1 country.
Salvador Navarro-Soto, PhD contact
Spain1 site
Corporacion Sanitaria Parc Taulí
Sabadell, Barcelona, 08208
Oriol Pino Pérez, MD, +34676607948, oriol.pino@gmail.com
About this study
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
- Being tested
- Brief Motivational Intervention
- Medical subject headings
- Wounds and Injuries, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Brief Motivational Intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of traumatisms
Any medical assistance related to a traumatism
Measured: Follow-up of 3 years
Secondary outcomes (3)
Alcohol prevalence
Alcohol prevalence among trauma patients
Measured: Trough study completion, an average of 2 years
Other drugs prevalence (cannabis, cocaine, methamphetamine)
Other drugs prevalence among trauma patients
Measured: 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.
Measured: Trough study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Sep 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvador Navarro-Soto, Corporacion Parc Tauli
- Investigators
- Salvador Navarro-Soto, PhD, Principal investigator, Corporacion Sanitaria Parc TauliSalvador Navarro-Soto, PhD, Study director, Corporacion Sanitaria Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967262
- Sponsor's protocol ID
- CSPT-CG-PPT2
- Status last verified
- Jan 2020
- First submitted
- 26 May 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention and Recidivism Reduction in Trauma Patients
- ClinicalTrials.gov ID
- NCT03967262
- Acronym / sponsor ID
- CSPT-CG-PPT2
- Conditions
- Trauma, Alcohol Use, Unspecified, Drug Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Brief Motivational Intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sever trauma patients defined as the need of assistance in a critical unit.
- Positive screening for alcohol o other drugs (cannabis, cocaine, methamphetamine).
Key exclusion criteria (4 listed)
- Patients in treatment for abuse of alcohol and other drugs.
- Death during hospitalization.
- Non Catalonia residents.
- Not Spanish or Catalan spoken.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Motivational InterventionThe 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. | Behavioural | Intervention |
Primary outcome
Recurrence of traumatisms
Time frame: Follow-up of 3 years
Any medical assistance related to a traumatism
3 secondary outcomes
Alcohol prevalence
Time frame: Trough study completion, an average of 2 years
Other drugs prevalence (cannabis, cocaine, methamphetamine)
Time frame: Trough study completion, an average of 2 years
Time to a recurrence
Time frame: Trough study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvador Navarro-Soto, PhD contact
Salvador Navarro-Soto, PhD principal investigator
Corporacion Sanitaria Parc Tauli
Salvador Navarro-Soto, PhD study director
Corporacion Sanitaria Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Intervention in people with Trauma and Alcohol Use, Unspecified, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oriol Pino-Perez, MD (+34676607948, oriol.pino@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of traumatisms (time frame: Follow-up of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.