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NCT Number: NCT04140344

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary lumbar fusion 1-4 levels
  • 18 years or older
  • Degenerative spine diagnosis
  • 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

  • Prior lumbar fusions
  • Tumors/infection/trauma
  • Prisoners or institutionalized patients
  • Non-English speaking patients
  • Patients who smokes or with uncontrolled diabetes
  • 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)

Treatment and study plan

Text Message Group

Other

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.

Other names: Guidance via text messaging to lumbar spine surgery patients post-operatively

Primary outcomes

  1. Change in readmission rates within 30 days post-lumbar spine surgery.

    Time frame: Baseline, 30 days

    Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire.

Secondary outcomes

  1. Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.

    Time frame: Baseline, 30 days

    Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery as measured by questionnaire.

  2. Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire.

    Time frame: 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).

  3. Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire.

    Time frame: 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).

Other outcomes

  1. Change in patient satisfaction levels within 30 days post-lumbar spine surgery.

    Time frame: Baseline, 30 days

    Change in patient satisfaction levels within 30 days post-lumbar spine surgery as measured by questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia E Pamanes, MPH

CONTACT

[email protected]

(919) 668-0897

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: NOTICE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 25, 2019
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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