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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spondylosis; Lumbar Spine Degeneration; Lumbar Spine Instability
• Intervention / Treatment: Other: Text Message Group

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 Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia E Pamanes, MPH; Phone Number: (919) 668-0897; Email: claudia.pamanes@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Neurosurgery and Duke Orthopedics
      • Contact: Beth Perry, RN, CCRP; Phone Number: (919) 681-2695; Email: beth.perry@duke.edu
      • Principal Investigator: Oren N Gottfried, MD FAANS
      • Contact: Claudia E Pamanes, MPH; Phone Number: 919-668-0897; Email: claudia.pamanes@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM 1: Text 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.	Other: Text 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.; Other Names: Guidance via text messaging to lumbar spine surgery patients post-operatively
No Intervention: ARM 2: Control group; The control group will be given the standard post-op packet that includes detailed instructions on proper wound care and signs and symptoms of infection. They will not receive text messages. The same outcomes will be assessed in both groups through a 30-day post-operative phone call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in readmission rates within 30 days post-lumbar spine surgery.	Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire.	Baseline, 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire.	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).	Baseline, 30 days
Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire.	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).	Baseline, 30 days
Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.	Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery as measured by questionnaire.	Baseline, 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient satisfaction levels within 30 days post-lumbar spine surgery.	Change in patient satisfaction levels within 30 days post-lumbar spine surgery as measured by questionnaire.	Baseline, 30 days

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Oren N Gottfried, MD FAANS, Duke Neurosurgery

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Text Message; Lumbar Fusion
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylosis
• Other Study ID Numbers: Pro00103904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No