Clinical trial NCT04140344: The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Official title: The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Spine Degeneration
Lumbar Spine Instability
Lumbar Spondylosis
Keywords: Lumbar Fusion
Text Message
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in readmission rates within 30 days post-lumbar spine surgery.
timeFrame: Baseline, 30 days
Secondary outcomes:
measure: Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.
timeFrame: Baseline, 30 days
measure: Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire.
timeFrame: Baseline, 30 days
measure: Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire.
timeFrame: Baseline, 30 days
Other outcomes:
measure: Change in patient satisfaction levels within 30 days post-lumbar spine surgery.
timeFrame: Baseline, 30 days
Locations:
city: Durham
country: United States
facility: Duke Neurosurgery and Duke Orthopedics
state: North Carolina
Study officials:
affiliation: Duke Neurosurgery
name: Oren N Gottfried, MD FAANS
role: PRINCIPAL_INVESTIGATOR
References: