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

NCT07819500 | Not Yet Recruiting

• 2 other identifiers: 2025-03529-012025
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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: dataskydd.sodersjukhuset@regionstockholm.se and dataskyddsombud@ki.se. 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.

Conditions

Intoxication; Delirium Tremens (DTs); Poisoning by Psychoactive Substances; Suicidal Attempt

Keywords

Intoxication; Self-poisoning; self-help tool

Outcome Measures

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.

  1,3 and 12 months post discharge.

Secondary Outcomes (1)

• Mortality

  1, 3 and 12 months post discharge.

Study Arms (2)

Intervention arm

EXPERIMENTAL

The patients in the intervention arm gets access to a new digital self-help tool at discharge from the ICU.

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

Control arm

ACTIVE COMPARATOR

Standard procedures at discharge.

Other: Preventox control group

Interventions

Preventox control group OTHER

Standard procedures at discharge.

Control arm

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

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.

Intervention arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Patients without a Swedish personal identity number.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

MeSH Terms

Conditions

Alcohol Withdrawal Delirium

Interventions

Critical Care

Condition Hierarchy (Ancestors)

Alcohol-Induced Disorders, Nervous System; Neurotoxicity Syndromes; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Märit Halmin, MD, PhD

  Karolinska Instiutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellinor Larsen, PhD student

CONTACT

0046708953208; ellinor.larsen@ki.se

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: MD, PhD

Model Details: Exploratory feasibility study as a RCT.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share