An interventional study of Decision support in Intervertebral Disc Displacement, Spinal Stenosis Lumbar and Lumbar Disc Herniation, sponsored by University Hospital of North Norway. Not yet recruiting at 1 site in Norway. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Other
Background One third of patients operated for lumbar disc herniation (LDH) or spinal stenosis (LSS) do not achieve substantial improvement. Studies indicate that well informed shared decision making (SDM) can improve the selection to surgery, and thus the outcomes. Numerous algorithms for outcome prediction have therefore been developed, and some use artificial intelligence (AI). Most are trained on small datasets, few are accurate, all are stand-alone or web-based applications not integrated in the electronic health record (EHR), and none are implemented in routine clinical practice.
The Norwegian registry for spine surgery (NORspine) comprises a cohort of more than 69,000 cases. The investigators have used AI to analyze the dataset and predict the outcome, and developed a decision support tool (DST) which is seamlessly integrated in the EHR DIPS Arena®.
The investigators intend to use the tool to inform the SDM between surgeons and patients about the indication for surgery (yes or no), to increase the proportion with a successful outcome. The aim of the study is to assess the safety and feasibility of the DST for use in a subsequent pilot study.
The device The DST (the device) is an integrate compound of software-solutions. Baseline data are registered by patients and surgeons on questionnaires integrated in DIPS Arena®, and transferred to NORspine. The data are also transferred (de-identified) to the AI-enabled prediction algorithm which operates in a cloud-based model hosting service. The algorithm has been trained and validated on a dataset from NORspine. The area under the curve for prediction of the main outcome (Oswestry disability index after12 months) in receiver operating characteristic analysis is very high (0.85) for LDH and moderate (0.72) for LSS. The model host also calculates outcomes (proportions with substantial, slight, or no improvement, and worsening) for the 50 cases with baseline variables most similar to the present case ("patients-like-me"). Finally, the individual prediction and the outcomes for the "patients-like-me" are transferred back and displayed in the regular user interface of DIPS Arena® for use in the SDM.
Clinical investigations For this feasibility study, the investigators will use convergent qualitative and quantitative mixed methods. The comparator is decision making in routine clinical practice, without use of the DST. The study will include 20 patients with magnetic resonance imaging confirmed LDH or LSS referred for evaluation of the indication for surgery, and six surgeons who do the evaluations. The study will iteratively redesign the user interface of the DST until it is considered safe and feasible for use in a following pilot study.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's planned enrollment of 26 is below the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →University Hospital of North Norway is the lead sponsor of 150 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients unable to consent because of
Patients and surgeons. Patients with lumbar disc herniation or lumbar spinal stenosis who will receive a digital form regarding patient-related outcome measures in advance of outpatient clinic, and will experience the use of the decision support in the consultation with the spine surgeon. Spine surgeons who will use the decision support in outpatient clinic to decide whether to perform spinal surgery.
Device: Decision support
Patients will digitally fill out forms, which will go into the decision support tool integrated in the electronic health record journal, which predicts outcome of surgery for the patient, to inform shared decision making.
Surgeons' acceptability
Surgeons' acceptability of the decision support for a following clinical pilot study (yes/no)
Time frame: Acceptability will be assessed continuously, but finally evaluated towards the end of the study, after iterative redesign of the DST and the related workflow according to requirements identified with qualitative methods at up to 70 weeks.
Patients' acceptability
Patients' acceptability of the decision support for a clinical pilot study (yes/no)
Time frame: Acceptability will be assessed continuously, but finally evaluated towards the end of the study, after iterative redesign of the DST and the related workflow according to requirements identified with qualitative methods at up to 70 weeks.
Surgeons' compliance rate
The proportion of consultations in which the surgeon uses the decision support as intended
Time frame: The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks.
Patients' compliance rate
The proportion of patients who complete the online questionnaire with the required information before the outpatient clinic visit
Time frame: The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks.
Time
Duration of the consultation (minutes)
Time frame: The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Due to data privacy concerns, individual data from interviews will not be available to others in other forms than the refined analyses and descriptions in open-access publications.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital of North Norway