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

Study acronym: MORESP
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Interventions modified · Secondary endpoints: details revised at 4 of 6 entries · Study description expanded, about 59 words · 3 more Show 6 more changesShow less
    • Interventions modified
    • Secondary endpoints: details revised at 4 of 6 entries
    • Study description expanded, about 59 words
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 9 of 10 entries
    • Eligibility criteria shortened, about 2 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07788872
Lead Sponsor University Hospital, Akershus
Collaborators: Sykehuset Innlandet HF
Conditions Spinal Stenosis Lumbar, Disc Herniation, Lumbar, Degenrative Disc Disease
Enrollment 440 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov