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

Duke University

Status: Enrolling

Conditions: Lumbar Spondylosis; Lumbar Spine Degeneration; Lumbar Spine Instability

Treatments: Other: Text Message Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04140344

Pro00103904

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

ARM 1: Text Message Group

Experimental group

Description:

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.

Treatment:

Other: Text Message Group

ARM 2: Control group

No Intervention group

Description:

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.