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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04140344
Status
Recruiting
Apply to this trial

Conditions

  • Lumbar Spine Degeneration
  • Lumbar Spine Instability
  • Lumbar Spondylosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Text Message Group — OTHER
    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.

Study Details

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.

Key Dates

Start date
Sep 7, 2023
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Change in readmission rates within 30 days post-lumbar spine surgery. [ Time Frame: Baseline, 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Neurosurgery and Duke OrthopedicsDurhamNorth Carolina27710
Claudia E Pamanes, MPH
[email protected]
919-668-0897
Beth Perry, RN, CCRP
[email protected]
(919) 681-2695
Oren N Gottfried, MD FAANS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By research site
Duke Neurosurgery and Duke Orthopedics· Durham, NC

Related Studies