More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Akershus
About this trial
This multicenter randomized controlled trial will evaluate whether an additional preoperative study visit using the Dialogue Support (DS) tool improves patient information, expectations, and outcomes among adults scheduled for lumbar spine surgery for degenerative spinal disorders.
The DS tool predicts outcomes one year after surgery based on patient characteristics and presents these estimates numerically and visually. Participants will be randomized to either one additional study visit in which DS results are presented and explained, or a control study visit during which DS will not be employed The study will assess whether the additional DS study visit influences postoperative outcomes, preoperative expectations, surgery cancellations, and cost-effectiveness. In addition, the project will externally validate the DS tool using data from the Norwegian Registry for Spine Surgery (NORspine) and assess the inter-rater reliability of DS assessments across spine surgeons.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Disc herniation
Spinal stenosis
Degenerative disc disease.
Disqualifiers
Patients who do not understand spoken or written Norwegian will be excluded, as language barriers may interfere with the intervention consultation, comprehension of the information provided, and completion of study questionnaires.
Patients with spondylolysis or lytic spondylolisthesis
Patients already participating in other clinical studies.
Trial design
Design model
Parallel
Treatments tested in this trial
Dialogue Support Study Visit
BehavioralThis study visit will be scheduled approximately 2-6 weeks prior to surgery. It will occur in the outpatient clinic and is expected to last approximately 30 to 40 minutes. It will be conducted in person to facilitate communication. During the study visit, the DS results are presented and explained to the patient.
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Dialogue Support Study VisitActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Oswestry Disability Index (ODI)
Disability measured using the Oswestry Disability Index (ODI), ranging from 0 to 100, with higher scores indicating greater disability. Mean ODI scores will be compared between the intervention and control groups.
Time frame
12 months follow-upSecondary outcomes
1
Successful Outcome According to Global Perceived Effect (GPE)
Proportion of participants achieving a successful outcome, defined as GPE grade 1 (completely recovered) or grade 2 (much better). The proportion of successful outcomes will be compared between groups.
Time frame
3 months and 12 months follow-up2
≥30% Improvement in Oswestry Disability Index (ODI)
Proportion of participants achieving at least a 30% improvement in ODI score from baseline.
Time frame
3 months and 12 months follow-up3
Oswestry Disability Index (ODI)
Mean ODI scores will be compared between groups.
Time frame
3 months follow-up4
Patient Expectations for Postoperative Disability
Patient expectations assessed preoperatively as the expected postoperative ODI score. Mean expected ODI scores will be compared between groups.
Time frame
After randomization and before surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Akershus
Lead sponsor
Sykehuset Innlandet HF
Collaborator
Source ClinicalTrials.gov