NCT Number: NCT07819500
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Background Internet-based healthcare interventions offer an alternative to conventional care and may reach patients who would otherwise not seek help, for instance owing to stigma. Intensive care provides a natural point of contact with, and an opportunity to influence patients with substance use disorders, however, research on psychiatric interventions in the intensive care context is lacking. At present, referral to psychiatric or addiction services is offered only where the responsible physician deems it relevant, and constitutes the sole aftercare option following intoxication requiring intensive care.
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, using the RedCap software, either to the intervention arm with access to Preventox or to standard discharge procedures. As some patients are discharged in a disoriented state, randomisation is in such cases performed at a later stage on the general ward by outreach intensive care staff. Patient recruitment takes place during a predefined period.
Inclusion criteria
patient 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.
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.
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. For readmission and death, the investigators will principally employ the Kaplan-Meier method. Binary outcomes will be analysed as proportions, with p-values estimated using the chi-square test or Fisher's exact test, depending on the number of events. Continuous outcomes will be examined using parametric or non-parametric methods, such as the t-test or the Wilcoxon test, depending on the variable and its distribution. The purpose is to test the entire study procedure ahead of a full-scale RCT.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 1, 3 and 12 months post discharge.
Mortality at 1, 3 and 12 months after the index admission.
Contact information is provided by the study sponsor or research team.
Karolinska Institutet
Other
Preventox - a Digital Self-help Tool for Patients With Intoxications in Intensive Care
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