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Text Messaging for Lumbar Spine Surgery Recovery (NOTICE Trial)

N/A

Recruiting

Led By Oren N Gottfried, MD FAANS

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Degenerative spine diagnosis

18 years or older

Must not have

Prior lumbar fusions

Non-English speaking patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare how effective informative text messages are to traditional handouts in helping patients recover from lumbar spine surgery.

Who is the study for?

This trial is for adults over 18 with degenerative spine conditions who are having lumbar fusion surgery. Participants must own and be comfortable using a mobile phone for daily texting. It's not for non-English speakers, smokers, those with uncontrolled diabetes, or anyone previously having lumbar fusions or certain other health issues.

What is being tested?

The study is testing if sending informative text messages to patients after their lumbar spine surgery helps better than traditional handouts. Patients will randomly receive either texts or handouts and the effectiveness of these methods will be compared.

What are the potential side effects?

Since this trial involves communication methods rather than medical treatments, there are no direct side effects related to medications or procedures. However, participants may experience varying levels of satisfaction or stress based on the method they receive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a degenerative spine condition.

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I am 18 years old or older.

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I had a spinal fusion surgery in my lower back involving 1 to 4 levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery to join two or more spine bones in my lower back.

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I do not speak English.

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I smoke or have diabetes that is not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in readmission rates within 30 days post-lumbar spine surgery.

Secondary study objectives

Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.

Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire.

Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire.

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ARM 1: Text Message GroupExperimental Treatment1 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.

Group II: ARM 2: Control groupActive Control1 Intervention

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.

0 / 6Eligibility criteria met