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

NCT ID: NCT04140344

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-07

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lumbar Spine Degeneration Lumbar Spine Instability Lumbar Spondylosis

Keywords

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Lumbar Fusion Text Message

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Text Message Group

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oren N Gottfried, MD FAANS

Role: PRINCIPAL_INVESTIGATOR

Duke Neurosurgery

Locations

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Duke Neurosurgery and Duke Orthopedics

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Claudia E Pamanes, MPH

Role: CONTACT

Phone: (919) 668-0897

Email: [email protected]

Facility Contacts

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Claudia E Pamanes, MPH

Role: primary

Beth Perry, RN, CCRP

Role: backup

Other Identifiers

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Pro00103904

Identifier Type: -

Identifier Source: org_study_id