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

Not Applicable

Recruiting

• Conditions: Lumbar Spondylosis; Lumbar Spine Degeneration; Lumbar Spine Instability

• Registration Number: NCT04140344
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

A total of 224 adult patients (18 years or older) undergoing spinal fusion surgery at Duke University Hospital, will be recruited from the Duke Department of Neurosurgery and the Duke Department of Orthopedics. Participants will be consented and will complete standard of care outcomes questionnaires (Visual Analogue Scale, Oswestry Disability Index and Euro-Quol 5D) at the pre-operative clinic visit for baseline comparison. Participants will be randomized, through REDCap, with equal probability to either: A) the control group, with standard post-surgery handouts, or B) the experimental group, which will receive text messages for a period of 2 weeks after surgery (daily for the first week, and every other day for the second week). Text messages were designed to be standardized and automated, with an embedded link to a video regarding at-home, post-surgery-care instructions. Patients will be directed not to respond to the text messages, but to call for any questions or concerns. The primary outcome will be a reduction in 30-days post-surgery readmission rates. The secondary outcomes will be a reduction in 30-days post-surgery ED visits rates, back and leg pain scores, and anxiety levels. These outcomes will be assessed via a phone interview at 30-days (up to max of 37 days) post-discharge for both groups.

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Study Start: 2023-09-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. Primary lumbar fusion 1-4 levels

2. 18 years or older

3. Degenerative spine diagnosis

4. Answers YES to all the following screening questions:

   • Do you own a mobile phone that is capable of sending and receiving text messages?
   • Do you know how to text and feel comfortable texting?
   • Are you a regular (at least once a day) text-message user?
   • Are you agreeable to regular contact?

Exclusion Criteria

1. Prior lumbar fusions
2. Tumors/infection/trauma
3. Prisoners or institutionalized patients
4. Non-English speaking patients
5. Patients who smokes or with uncontrolled diabetes
6. Participants will be removed from study if discharged to a rehabilitation center or discharged beyond 7 days post-operatively (we are expecting ~15% of patients to be discharged to a rehabilitation center or discharged beyond 7 days post-operatively)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in readmission rates within 30 days post-lumbar spine surgery.	Baseline, 30 days	Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire.

Secondary Outcome Measures

Name	Time	Method
Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.	Baseline, 30 days	Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery as measured by questionnaire.
Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire.	Baseline, 30 days	The EQ-5D is an instrument to quantify health-related quality of life. Scores can be reported as a five digit number in a range from 11111 (full health) to 55555 (worst health).
Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire.	Baseline, 30 days	ODI questionnaire is a tool to evaluate a subjective level of functional disability in daily living activities in patients with low back pain. Scores go from 0% (no disability) to 100% (maximum disability possible).

Trial Locations

Locations (1)

Duke Neurosurgery and Duke Orthopedics; 🇺🇸 Durham, North Carolina, United States