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

NCT04140344 | Recruiting DMC

• 1 other identifier: Pro00103904
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Degeneration; Lumbar Spine Instability; Lumbar Spondylosis

Keywords

Lumbar Fusion; Text Message

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Baseline, 30 days

• 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

• 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

Other Outcomes (1)

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

  Baseline, 30 days

Study Arms (2)

ARM 1: Text Message Group

EXPERIMENTAL

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

ARM 2: Control group

NO INTERVENTION

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.

Interventions

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.

Also known as: Guidance via text messaging to lumbar spine surgery patients post-operatively

ARM 1: Text Message Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary lumbar fusion 1-4 levels
• 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?

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Neurosurgery and Duke Orthopedics

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Oren N Gottfried, MD FAANS

  Duke Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia E Pamanes, MPH

CONTACT

(919) 668-0897; claudia.pamanes@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be told they will receive appropriate information about their spine surgery (including instructions on proper wound care, mobility, and signs and symptoms of infection) in general, either through phone calls, text messages and/or handouts, without specifying the difference between the control and the intervention group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following baseline assessments, subjects will be randomized with equal probability to one of two arms: 1). The experimental arm, which will receive automated standardized text messages at predetermined intervals, occurring daily the first week post-operatively and gradually tapering over the second week; 2). The control arm - where subjects will not receive any scheduled contact (outside of standard of care phone interactions). All subjects will receive a phone call 30 days (up to 37 days) post-discharge in order to complete the study questionnaires.

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 25, 2019
• Study Start: September 7, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)