Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

Background and purpose At present, occasional referral to psychiatric or addiction services is the only aftercare option offered following an intoxication/overdose requiring intensive care. The investigators intend to test whether a new self-help tool can serve as a complement to this, and are now conducting a pilot study to determine whether the application could help prevent further severe intoxications/overdoses. The research principals for the project - ie the responsible organizations, are Region Stockholm and Karolinska Institutet. The research has been approved by the Swedish Ethical Review Authority; the reference number for the review is 2025-03529-01.

How is the study conducted? You will receive a brochure/card with information and access to the self-help tool called Preventox. Preventox is a website where you can create a personal login and set goals, keep an alcohol/substance diary, identify high-risk situations, create a crisis plan, learn about cravings, and obtain information on where to turn if you need support. No one other than you and the participating researchers can see what you record under your login. A reminder will be sent via 1177.

After 12 months, the investigators will use registry data to determine whether you have received care for a further intoxication/overdose. Only participating researchers will have access to this information, which will subsequently be de-identified.

Data handling and confidentiality Use of the service is entirely personal, i.e. only you have access to your login and the information you record there. Registry data will be processed confidentially and thereafter de-identified, so that no unauthorised person can access your information. Medical record review may be carried out to validate procedures. The results of the study will be presented at group level. Responsible for your personal data are the Emergency Hospitals Board, Region Stockholm, and Karolinska Institutet. Data will be stored in accordance with the recommendations of Karolinska Institutet and Section 3 of the Swedish Archives Act (1990:782).

Under the EU General Data Protection Regulation, you have the right to obtain, free of charge, access to the information about you that is processed within the project, and to have any errors corrected. You may also request that information about you will be erased and that the processing of your personal data will be restricted. If you wish to access the information, please contact the responsible researcher listed below.

The Data Protection Officers can be reached by email at: [email protected] and [email protected].

Information about the study results and questions If you wish, the results can be shared with you on request. If you have any other questions, you are welcome to contact the persons listed below.

Voluntary participation Participation is entirely voluntary. You may discontinue your participation in the study at any time, without explanation and without giving any reason, and without this affecting your other care and treatment. If you wish to do so, please contact one of the contact persons listed below.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged =>18 years; treated at the IMA/MIVA units at Södersjukhuset, during a defined period; assigned a discharge code according to ICD-10 relating to unintentional or intentional poisoning by intoxicants (F10.0-F17.0, F19.0), or a discharge code according to ICD-10 relating to alcohol-induced withdrawal with delirium (F10.4), or treated for seizures related to alcohol or benzodiazepine withdrawal; Swedish- or English-speaking.

Disqualifiers

Patients without a Swedish personal identity number.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preventox, a digital self-help tool for patients with intoxications in intensive care.

    Other intervention

    The intervention consists of a digital self-help tool that patients get access to at discharge from the ICU. All patients are followed up after 12 months via the National Patient Register, the Swedish Intensive Care Registry and the Cause of Death Register with respect to readmission, emergency department visits within somatic acute care, and death at 1, 3 and 12 months after the index admission.

  • Preventox control group

    Other intervention

    Standard procedures at discharge.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Readmission

Readmissions and emergency department visits within somatic acute care at 1, 3 and 12 months after the index admission, related to intoxication with alcohol and/or illicit drugs, withdrawal seizures, or delirium tremens.

Time frame
1,3 and 12 months post discharge.

Secondary outcomes

1

Mortality

Mortality at 1, 3 and 12 months after the index admission.

Time frame
1, 3 and 12 months post discharge.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Region Stockholm

Collaborator

This trial is not recruiting at the moment. You can still explore other options: