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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05745129
Other study ID # 371282
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date December 31, 2028

Study information

Verified date February 2024
Source Oslo Metropolitan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective is to use machine learning methods on large survey and health register data to identify participants with different treatment trajectories and health outcomes after surgical and/or conservative treatment for spinal disorders. Secondary objectives are to 1) conduct external validation of the prediction models, and 2) explore how the prediction models can be implemented into AI-based clinical co-decision tools and interventions.


Description:

Three work packages are conducted. In the first, the investigators will use data from three general population surveys in Norway (HUNT, Tromsø, and Ullensaker) linked to administrative health registry data (Norwegian Patient Registry (for secondary care) and Norwegian Registry for Primary Health Care) and clinical registers on spinal disorders (the Norwegian registry for spine surgery, NorSpine, and the Norwegian registry for neck and back pain) to explore treatment trajectories and health outcomes following an episode of back and/or neck pain. The investigators will use different combinations of these data sets to assess the impact of a wide range of risk/ prognostic factors and to develop prognostic models for different health and welfare outcomes. Four major outcomes will be adressed; a) unfavourable outcomes, b) use of prescribed medication, c) use of sickness absence and other disability benefits, and d) patient-reported outcomes. In the second work package, the investigators will conduct external validation studies of the prediction models by using Danish and Swedish data. There is a large overlap and similarities in health and welfare registers across the Nordic countries. In the third work package the investigators will first conduct a feasibility study in a secondary care hospital setting in which surgeons examine and assess referred patients with disc herniation and spinal stenosis for surgical treatment (or not). Qualitative interviews will be used to gain a better understanding of today's clinical decision-making process.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 165000
Est. completion date December 31, 2028
Est. primary completion date December 31, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: patients referred to secondary care for assessment of surgery or not due to disc herniation (lumbar or cervical). - Exclusion Criteria: ambulant cases who needs immediate treatment -

Study Design


Locations

Country Name City State
Norway Oslo Metropolitan University Oslo Norge

Sponsors (1)

Lead Sponsor Collaborator
Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-reported outcomes Patient-reported outcome measures included in clinical registers depends upon the registry data, but in general between 2008 and 2022
Primary Unfavourable outcomes Healthcare utilization, reoperation, infection, or other complications after surgery. depends upon the registry data, but in general between 2008 and 2022
Primary Prescribed medication High use of prescribed medication (dispensed drugs) depends upon the registry data, but in general between 2008 and 2022
Primary Sickness absence Sickness absence and disability pension depends upon the registry data, but in general between 2008 and 2022
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