Evaluating text messages versus handouts for lumbar spine surgery recovery
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
NA · Duke University · NCT04140344
This study is testing whether sending daily text messages or giving out handouts helps adults recover better after lumbar spine surgery by reducing hospital readmissions and improving their pain and anxiety levels.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04140344 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of informative text messages against traditional handouts for patients recovering from lumbar spine surgery. A total of 224 adult patients will be randomly assigned to receive either standard post-operative handouts or daily text messages for two weeks after surgery. The text messages will include links to videos with care instructions and will not allow for patient responses. The primary goal is to reduce readmission rates within 30 days post-surgery, while secondary outcomes include emergency department visits and pain and anxiety levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing primary lumbar fusion surgery with a degenerative spine diagnosis.
Not a fit: Patients with prior lumbar fusions, non-English speakers, or those with uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery outcomes and reduced hospital readmissions for lumbar spine surgery patients.
How similar studies have performed: Other studies have shown promising results using text messaging for patient education and follow-up, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Durham, North Carolina
- Duke Neurosurgery and Duke Orthopedics — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Oren N Gottfried, MD FAANS — Duke Neurosurgery
- Study coordinator: Claudia E Pamanes, MPH
- Email: claudia.pamanes@duke.edu
- Phone: (919) 668-0897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylosis, Lumbar Fusion, Text Message