Safe AI-assisted Fall Prevention Through Evidence
Trial ID: NCT07503665
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-01-01
Completion date: 2028-12
Sponsor: Halmstad University
Conditions: Fall
Interventions: Not applicable- observational study
Locations: Sahlgrenska Hospital
Countries: Sweden
Enrollment: 23425
Age range: 18 Years - None
Sex: ALL

Summary:
The goal of this multi-method study is to investigate how AI-assisted fall-prevention are implemented in routine hospital care what their effects are. The main questions it aims to answer are how these AI systems influence patient safety outcomes, how they affect healthcare professionals work and healthcare resource use, and what factors support or hinder their sustainable integration into hospital environments.

Eligibility criteria:
Individual interviews with key actors in the implementation

Inclusion criteria:

1. Be employed at one of the participating hospitals
2. Hold a role as a key stakeholder in the implementation work
3. Have experience with the implementation of the AI-assisted fall prevention
4. Have the ability to understand and communicate in Swedish

Exclusion criteria:

1\. Have insufficient proficiency in Swedish to participate in an interview or observation and to understand the purpose and content of the study

Individual interviews with managers

Inclusion criteria:

1. Be employed as a manager at one of the participating hospitals
2. Have experience with the implementation or use of the AI-assisted fall prevention
3. Have the ability to understand and communicate in Swedish

Exclusion criteria:

1\. Have insufficient proficiency in Swedish to participate in an interview or observation and to understand the purpose and content of the study

Individual interviews with staff

Inclusion criteria:

1. Be employed as staff on a ward at one of the participating hospitals where the AI-assisted fall prevention has been decided to be implemented
2. Have experience with the implementation or use of the AI-assisted fall prevention
3. Have the ability to understand and communicate in Swedish

Exclusion criteria:

1\. Have insufficient proficiency in Swedish to participate in an interview or observation and to understand the purpose and content of the study

Observations of staff work

Inclusion criteria:

1. Be employed as staff on a ward at one of the participating hospitals where the AI-assisted fall prevention has been decided to be implemented
2. Have experience with the implementation or use of the AI-assisted fall prevention
3. Have the ability to understand and communicate in Swedish

Exclusion criteria:

1\. Have insufficient proficiency in Swedish to participate in an interview or observation and to understand the purpose and content of the study

Individual interviews with patients and family members:

Inclusion criteria (for family members, only inclusion criterion 1b applies):

1. Either (a) have been a patient on a ward at one of the participating hospitals where the AI-assisted fall prevention has been implemented, or (b) be a family member involved in the care of a patient who meets the inclusion criteria but lacks the ability to provide informed consent. The family member must be able to understand and communicate in Swedish
2. Have experience with the AI-assisted fall prevention as part of their care
3. Have the ability to understand and communicate in Swedish
4. Be 18 years of age or older
5. Have the ability to provide informed consent. If there is any uncertainty regarding a patient's ability to provide informed consent, the research team will refrain from conducting the interview.

Exclusion criteria:

1. Have insufficient proficiency in Swedish to participate in an interview or observation and to understand the purpose and content of the study
2. Lack the ability to provide informed consent

Web-based surveys with staff:

Inclusion criteria:

1. Be employed as staff on a ward at one of the participating hospitals where the AI-assisted fall prevention is decided to be implemented.

Exclusion criteria:

1. Not being employed on a ward at one of the participating hospitals where the AI-assisted fall prevention is decided to be implemented
2. Lack the ability to access information and respond to the survey in Swedish

Retrospective medical record data:

Inclusion criteria:

1\. Patients who have been cared for on a ward at one of the participating hospitals where the AI-assisted fall prevention has been implemented, either (a) up to 24 months after implementation or (b) up to 12 months before implementation.

Exclusion criteria:

1\. Patients who have only received care outside the defined time period, meaning not within 24 months after or 12 months before the implementation of the AI-assisted fall prevention

Learning labs:

Inclusion criteria:

1. (a) Be employed at one of the participating hospitals and hold a role as a key stakeholder in the implementation work, or be staff or a manager with experience of the implementation or use of the AI-assisted fall prevention; or (b1) have been a patient cared for on a ward at one of the participating hospitals where the AI-assisted fall prevention has been implemented and have experience with the AI-assisted fall prevention as part of their care; or (b2) be a family member of a patient with such experience; or (c) be a patient representative for a patient group, patient organization, or user organization where falls are an identified issue
2. Have the ability to understand and communicate in Swedish

Exclusion criteria:

1. Have insufficient proficiency in Swedish to participate in an interview or observation and to understand the purpose and content of the study
2. Lack the ability to provide informed consent

Outcomes:
Fall rate