Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04140344

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

Led by Duke University · Updated on 2026-05-08

224

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of automated informative text messages compared to traditional handouts for patients who have undergone lumbar spine fusion surgery. This randomized, single-blind study aims to assess whether receiving text messages after surgery can reduce readmission rates within 30 days. The study involves adult patients with degenerative spine conditions undergoing 1 to 4 level lumbar fusion at Duke University Hospital. Participants will be randomly assigned to one of two groups. The control group will receive standard post-surgery handouts with detailed care instructions. The experimental group will receive automated text messages daily for the first week and every other day during the second week after surgery. These messages include links to videos with further advice and encourage patients to call with any questions. Both groups will be followed up with a phone call 30 days after surgery to assess outcomes. During the study, participants will complete questionnaires before surgery and at 30 days post-discharge to measure pain, disability, and anxiety levels. Researchers will track hospital readmissions, emergency department visits, phone calls, and messages to providers, as well as pain medication use and any new problems such as infections. The total participation involves the pre-operative visit, a 2-week messaging or handout period, and a 30-day follow-up call to evaluate recovery and healthcare use.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary lumbar fusion surgery involving 1 to 4 levels
  • Age 18 years or older
  • Diagnosed with degenerative spine condition
  • Owns a mobile phone capable of sending and receiving text messages
  • Comfortable using text messaging and uses it at least once daily
  • Agrees to receive regular contact via text messages after surgery
Not Eligible

You will not qualify if you...

  • Previous lumbar fusion surgeries
  • Presence of tumors, infections, or trauma related to spine
  • Prisoners or patients in institutionalized care
  • Non-English speaking patients
  • Current smokers or patients with uncontrolled diabetes
  • Patients discharged to rehabilitation centers or discharged more than 7 days after surgery (may be removed from study)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 pre-operative clinic visit (in-person) for baseline assessments and consent

Surgery and Immediate Post-operative Care

Duration - Hospital stay until discharge (up to 7 days)

Participants undergo lumbar fusion surgery and receive standard post-operative care.

Hospital stay with standard post-operative monitoring

Treatment

Duration - 2 weeks post-surgery

Participants are randomized to receive either standard post-surgery handouts or automated text messages for post-surgery care support.

Daily text messages for the first week and every other day for the second week (for the text message group)

Follow-up

Duration - Up to 37 days post-discharge

Participants complete a phone interview to assess health status, including readmission rates, emergency visits, pain levels, and anxiety within 30 days after surgery.

1 phone interview visit at approximately 30 days post-discharge

Trial Site Locations

Total: 1 location

1

Duke Neurosurgery and Duke Orthopedics

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

C

Claudia E Pamanes, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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