RecruitingNot ApplicableNCT04140344

The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions


Sponsor

Duke University

Enrollment

224 participants

Start Date

Sep 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called NOTICE) evaluates whether text message-based communication between patients and their surgical teams after lumbar spinal fusion surgery improves patient outcomes and reduces complications. Lumbar fusion is surgery to join together two or more vertebrae in the lower back to stabilize the spine and reduce pain. After discharge, communication gaps can lead to missed warning signs. Participants will receive regular text check-ins from their care team and the study will compare their recovery, satisfaction, and complication rates to historical benchmarks. You may be eligible if: - You are 18 years or older - You are having primary lumbar fusion at 1 to 4 levels for a degenerative spine condition - You own a mobile phone capable of text messaging and use it regularly (at least once daily) - You are comfortable texting and agree to regular contact You may NOT be eligible if: - You have had previous lumbar fusion surgery - Your surgery is for a tumor, infection, or trauma - You smoke or have uncontrolled diabetes - You do not speak English - You are a prisoner or institutionalized patient Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERText Message Group

The intervention group will receive automated text messages every day for the first week, and every other day for the second week post-operatively. The text messages will follow a series of pre-defined standardized scripts (Appendix 3) with embedded hyperlinks to a video from the providers with further advice. The patient is directed not to respond to the text messages, but to call for any questions or concerns. The text message group will receive a 30-day post-operative phone call to evaluate: number of ED visits, hospital readmissions, and to re-administer the questionnaires completed at baseline visit. Other data to be collected may include the following: number of phone calls to provider, MyChart messages to provider, pain medications, and new problems like pain and infection.


Locations(1)

Duke Neurosurgery and Duke Orthopedics

Durham, North Carolina, United States

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NCT04140344


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