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

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ClinicalTrials.gov Identifier: NCT04140344
Recruitment Status : Not yet recruiting
First Posted : October 25, 2019
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Lumbar Spine Degeneration Lumbar Spine Instability Lumbar Spondylosis Other: Text Message Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 448 participants
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
Official Title: The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
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.
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

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 Measures :
  1. Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire. [ Time Frame: Baseline, 30 days ]

Secondary Outcome Measures :
  1. Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery as measured by questionnaire. [ Time Frame: Baseline, 30 days ]
  2. 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).

  3. 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).


Other Outcome Measures:
  1. Change in patient satisfaction levels within 30 days post-lumbar spine surgery as measured by questionnaire. [ Time Frame: Baseline, 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140344


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

Locations
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United States, North Carolina
Duke Neurosurgery and Duke Orthopedics
Durham, North Carolina, United States, 27710
Contact: Claudia E Pamanes, MPH    (919) 668-0897    claudia.pamanes@duke.edu   
Contact: Beth Perry, RN, CCRP    (919) 681-2695    beth.perry@duke.edu   
Principal Investigator: Oren N Gottfried, MD FAANS FACS         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Oren N Gottfried, MD FAANS FACS Duke Neurosurgery
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04140344    
Other Study ID Numbers: Pro00103904
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Lumbar Fusion
Text Message
Additional relevant MeSH terms:
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Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases