AID-Spine: Applying Artificial Intelligence in Developing Personalized and Sustainable Healthcare for Spinal Disorders

Sponsor

Oslo Metropolitan University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05745129

Collaborator

(none)

165,000

Enrollment

Location

Anticipated Duration (Months)

4586.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Neck Pain Disc Herniation Disc Degeneration Spinal Stenosis Radiculopathy

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

165000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Applying Artificial Intelligence in Developing Personalized and Sustainable Healthcare for Spinal Disorders (AID-Spine, Part I)

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Treatment cohort Surgical vs conservative treatment. Surgery procedures are based on the NOMESCO Classification of Surgical Procedures (NCSP). Conservative treatment includes all non-surgical treatment methods such as pharmaceutical treatment, physical medicine and physiotherapy modalities (information, patient education, exercise, manual therapy etc), cognitive-behavioural therapy, multidisciplinary treatment, acupuncture, and others (e.g. chiropractic treatment, homeopathy, naprapathy, osteopathy). The results will be described for important spinal subgroups (specific diagnoses, nerve-root affections, and non-specific conditions).

Arm

Intervention/Treatment

Treatment cohort

Surgical vs conservative treatment. Surgery procedures are based on the NOMESCO Classification of Surgical Procedures (NCSP). Conservative treatment includes all non-surgical treatment methods such as pharmaceutical treatment, physical medicine and physiotherapy modalities (information, patient education, exercise, manual therapy etc), cognitive-behavioural therapy, multidisciplinary treatment, acupuncture, and others (e.g. chiropractic treatment, homeopathy, naprapathy, osteopathy). The results will be described for important spinal subgroups (specific diagnoses, nerve-root affections, and non-specific conditions).

Outcome Measures

Primary Outcome Measures

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