Preventox - a Digital Self-help Tool for Patients With Intoxications in Intensive Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 50
- Primary Endpoint
- Readmission
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intervention arm
The patients in the intervention arm gets access to a new digital self-help tool at discharge from the ICU.
Intervention: Preventox, a digital self-help tool for patients with intoxications in intensive care. (Other)
Control arm
Standard procedures at discharge.
Outcomes
Primary Outcomes
Readmission
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.
Secondary Outcomes
- Mortality(1, 3 and 12 months post discharge.)
Investigators
Märit Halmin
MD, PhD
Karolinska Institutet