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

Lumbar Spine Degeneration Clinical Trial

— NOTICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04140344
• Other study ID #: Pro00103904
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: October 2024

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: Claudia E Pamanes, MPH
• Phone: (919) 668-0897
• Email: claudia.pamanes[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lumbar Spine Degeneration
• Lumbar Spine Instability
• Lumbar Spondylosis
• Spondylosis

Intervention

Other:
• Text Message Group
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.

Locations

Country	Name	City	State
United States	Duke Neurosurgery and Duke Orthopedics	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline, 30 days
Primary	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	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
Secondary	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
Secondary	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