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More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.

NCT07788872 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2026-08-27

No results posted yet for this study

Summary

This multicenter randomized controlled trial will evaluate whether an additional preoperative consultation 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 standard preoperative care or standard care plus an additional consultation in which DS results are presented and explained.

The study will assess whether the additional DS consultation 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.

Conditions

  • Spinal Stenosis Lumbar
  • Disc Herniation, Lumbar
  • Degenrative Disc Disease

Interventions

BEHAVIORAL

Dialogue Support Consultation

This consultation will be scheduled approximately 2-6 weeks prior to surgery. The consultation 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 consultation, the DS results are presented and explained to the patient.

Sponsors & Collaborators

  • Sykehuset Innlandet HF

    collaborator OTHER

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Per-Henrik Randsborg, MD, PhD · University Hospital, Akershus

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-09-01
Completion
2031-09-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788872 on ClinicalTrials.gov