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

ConditionsLumbar Spine Degeneration Lumbar Spine Instability Lumbar Spondylosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary lumbar fusion 1-4 levels

18 years or older

Degenerative spine diagnosis

Do you own a mobile phone that is capable of sending and receiving text messages?

Disqualifiers

Prior lumbar fusions

Tumors/infection/trauma

Prisoners or institutionalized patients

Non-English speaking patients

Trial design

Design model

Parallel

Treatments tested in this trial

Text Message Group
Other intervention
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 groups

224 Participants

are divided into 2 treatment groups

Group A: ARM 1: Text Message GroupExperimental treatment 1 intervention

Group B: ARM 2: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Baseline, 30 days

Secondary outcomes

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.

Time frame

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).

Time frame

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).

Time frame

Baseline, 30 days

Other outcomes

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

Change in patient satisfaction levels within 30 days post-lumbar spine surgery as measured by questionnaire.

Time frame

Baseline, 30 days

Sponsors and contacts

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Duke University

Lead sponsor

Source ClinicalTrials.gov

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