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

18. september 2026 opdateret af: Märit Halmin, Karolinska Institutet

Preventox - a Digital Self-help Tool for Patients With Intoxications in Intensive Care

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.

Studieoversigt

Detaljeret beskrivelse

Preventox is an internet-based self-help tool developed by The Stockholm Centre for Dependency Disorders together with the medical intensive care unit Södersjukhuset. In-depth interviews with patients who have received intensive care for intoxications have been conducted prior to study commencement, in order to provide a basis for modifying the application so that it better corresponds to the intensive care context and to the patient group concerned.

Aim To determine whether a larger randomised controlled trial (RCT) would be feasible in practice, and to evaluate whether the self-help tool Preventox could contribute to reduced mortality and to a reduction in readmissions and emergency department visits within somatic acute care related to alcohol and illicit drug use.

Methods A two-arm randomised controlled pragmatic pilot/feasibility study in patients treated in an intensive care unit or intermediate care unit in Stockholm for intoxication with alcohol or illicit drugs, withdrawal seizures, or delirium tremens. A power calculation for the intervention study conducted as a full RCT indicated that approximately 300 patients per arm would be required to demonstrate a 10% reduction in the readmission rate. The present study is instead planned as an exploratory feasibility study, with patients recruited over a limited period of approximately one year.

Recruitment and randomisation take place once the patient is somatically ready for discharge from intensive or intermediate care, immediately prior to discharge. All patients receive information about the study, and consent is obtained. Participants are thereafter enrolled and randomised, either to the intervention arm with access to Preventox or to standard discharge procedures. Patient recruitment takes place during a predefined period. All patients are followed up after 12 months with respect to readmission, emergency department visits within somatic acute care, and death at 1, 3 and 12 months after the index admission.

Outcome measures: the primary outcomes are 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. The secondary outcome is mortality at 1, 3 and 12 months after the admission.

The feasibility of the study will be analysed descriptively on the basis of the feasibility measures of acceptability, recruitment and resources, together with preliminary outcomes. The purpose is to test the entire study procedure ahead of a full-scale RCT.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients without a Swedish personal identity number.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention arm

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

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.

Aktiv komparator: Control arm

Standard procedures at discharge.

Standard procedures at discharge.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Readmission
Tidsramme: 1,3 and 12 months post discharge.

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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mortality
Tidsramme: 1, 3 and 12 months post discharge.

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

1, 3 and 12 months post discharge.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Märit Halmin, MD, PhD, Karolinska Instiutet

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. september 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

9. september 2026

Først indsendt, der opfyldte QC-kriterier

9. september 2026

Først opslået (Faktiske)

15. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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