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

• ClinicalTrials.gov Identifier: NCT04140344
• Recruitment Status: Not yet recruiting
• First Posted: October 25, 2019
• Last Update Posted: April 12, 2023
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: October 24, 2019
• First Posted Date: October 25, 2019
• Last Update Posted Date: April 12, 2023
• Estimated Study Start Date: June 1, 2023
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 2023)

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

Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire.

• Original Primary Outcome Measures (submitted: October 24, 2019): Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire. [ Time Frame: Baseline, 30 days ]

Current Secondary Outcome Measures (submitted: April 10, 2023)

• Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery. [ Time Frame: Baseline, 30 days ]
  Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery as measured by questionnaire.
• Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire. [ Time Frame: Baseline, 30 days ]
  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).
• Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire. [ Time Frame: Baseline, 30 days ]
  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).

Original Secondary Outcome Measures (submitted: October 24, 2019)

• 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 ODI questionnaire. [ Time Frame: Baseline, 30 days ]
• Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by EQ-5D questionnaire. [ Time Frame: Baseline, 30 days ]

Current Other Pre-specified Outcome Measures (submitted: April 10, 2023)

Change in patient satisfaction levels within 30 days post-lumbar spine surgery. [ Time Frame: Baseline, 30 days ]

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

• Original Other Pre-specified Outcome Measures (submitted: October 24, 2019): Change in patient satisfaction levels within 30 days post-lumbar spine surgery as measured by questionnaire. [ Time Frame: Baseline, 30 days ]

Descriptive Information

• Brief Title: The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
• Official Title: The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
• Brief 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.
• Detailed Description: A total of 448 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Following baseline assessments, subjects will be randomized with equal probability to one of two arms: 1). The experimental arm, which will receive automated standardized text messages at predetermined intervals, occurring daily the first week post-operatively and gradually tapering over the second week; 2). The control arm - where subjects will not receive any scheduled contact (outside of standard of care phone interactions). All subjects will receive a phone call 30 days (up to 37 days) post-discharge in order to complete the study questionnaires.

Masking: Single (Participant)
Masking Description:

Participants will be told they will receive appropriate information about their spine surgery (including instructions on proper wound care, mobility, and signs and symptoms of infection) in general, either through phone calls, text messages and/or handouts, without specifying the difference between the control and the intervention group.

Primary Purpose: Other

Condition

• Lumbar Spine Degeneration
• Lumbar Spine Instability
• Lumbar 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.

Other Name: Guidance via text messaging to lumbar spine surgery patients post-operatively

Study 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.
  Intervention: Other: Text Message Group
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 24, 2019): 448
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Claudia E Pamanes, MPH; (919) 668-0897; claudia.pamanes@duke.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04140344
• Other Study ID Numbers: Pro00103904
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Duke University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Oren N Gottfried, MD FAANS; Duke Neurosurgery

• PRS Account: Duke University
• Verification Date: November 2022