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

Study Overview
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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.

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

Conditions
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Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylosis

Intervention / Treatment
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* Other: Text Message Group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM 1: Text Message Group<br>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<br>* 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.<br>* Other names: Guidance via text messaging to lumbar spine surgery patients post-operatively;|
| No Intervention: ARM 2: Control group<br>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?
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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 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Fusion, Text Message