The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Primary lumbar fusion 1-4 levels
• 18 years or older
• Degenerative spine diagnosis
• 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?
Locations
United States
North Carolina
Duke Neurosurgery and Duke Orthopedics
RECRUITING
Durham
Contact Information
Primary
Claudia E Pamanes, MPH
claudia.pamanes@duke.edu
(919) 668-0897
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2027-10
Participants
Target number of participants: 224
Treatments
Experimental: ARM 1: 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.
No_intervention: ARM 2: Control group
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: Duke University