Digital, Innovative, Sustainable, and Knowledge-based Acu... | NCT05708768

Studies
Digital, Innovative, Sustainable, and Knowledge-based Acute Municipal Healthcare Services Illness and Trauma

NCT05708768

Sponsor

Ostfold University College

Status

Completed

Last Update Posted

Aug 8, 2025Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Multiple Chronic Conditions
Acute Disease

Interventions

Receiving physician manned rapid response car services

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Jan 1, 2025Actual

Completion Date

Jan 1, 2025Actual

First Submitted Date

Jan 23, 2023

First Submission Date that Met QC Criteria

Jan 23, 2023

First Posted Date

Feb 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2025

Last Update Posted Date

Aug 8, 2025Actual

Name	Class
Oslo University Hospital	OTHER
Ostfold Hospital Trust	OTHER
OsloMet	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Through introducing physicians in front in the medical assessment and decision-making processes in acute and sub-acute illness in the municipalities, as well as including machine learning in analyzing prospective and retrospective data, the project will develop and implement innovative and knowledge-based digital diagnostic tools and decision-making support systems to be used in the municipalities. As such, the project will contribute to early identification of severe illness, prevent deterioration of disease, and facilitate early medical intervention.

Detailed Description

The overall objective of the project is to determine if and how innovative digital decision-making tools based on artificial intelligence (AI) can help to develop more accessible, efficient, cost-effective, and sustainable municipal healthcare services. More specifically, the project aims are:

to explore different outcomes of a municipal rapid response car manned with dedicated physicians
to compare outcomes from Norwegian and Swedish out-of-hospital EMS in acute illness
to explore how decision-making tools based on AI can be used to optimize dispatch
to explore how decision-making tools based on AI can assist dispatched personnel and in prehospital care
to determine the quality and efficacy of the different systems explored through cost-analyses and exploration of stakeholders' experiences with the decision-making tools

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acutely ill persons in the municipality		Patients recieving services from a rapid response vehicle manned with dedicated physicians from the municipality	Other: Receiving physician manned rapid response car services

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Receiving physician manned rapid response car services	Other	All patients receiving services from the physician manned rapid response car will be included	Acutely ill persons in the municipality

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
At location	Patients treated at location	2 hours

Secondary Outcomes

Measure	Description	Time Frame
Transported	Patients being transported for further diagnostics	2 hours

Other Outcomes

Measure	Description	Time Frame
Institutionalized	Patients being institutionalized	12 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:all patients receiving services from the physician manned rapid response car -

Exclusion Criteria:none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients recieving services from the physician manned rapid response car will be included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Randi M Sommerfelt, PhD	Østfold University College	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fredrikstad Casualty		Fredrikstad	Akershus	1671	Norway

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The goal is to publish anonymized datasets. ØUC is an institutional member of the DataverseNO community in Norway, and the DataverseNO-based repository ØUC Open Research Data, which is a generic repository of high quality, is suitable for this endeavor. A part of the data generated by this research project consists of qualitative interviews. In case these data cannot be anonymized, open publication of data will be refrained and rather opt for making metadata available. Datasets and metadata will be published in connection with open access publication of research articles.

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

After all publication

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071069	Multiple Chronic Conditions
D000208	Acute Disease

Ancestor Terms

ID	Term
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided