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

Primary Purpose

Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message Group
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lumbar Spine Degeneration focused on measuring Lumbar Fusion, Text Message

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Duke Neurosurgery and Duke OrthopedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ARM 1: Text Message Group

ARM 2: Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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).

Full Information

First Posted
October 24, 2019
Last Updated
September 19, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04140344
Brief Title
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Acronym
NOTICE
Official Title
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylosis
Keywords
Lumbar Fusion, Text Message

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM 1: Text Message Group
Arm Type
Experimental
Arm Description
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.
Arm Title
ARM 2: Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Text Message Group
Other Intervention Name(s)
Guidance via text messaging to lumbar spine surgery patients post-operatively
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in readmission rates within 30 days post-lumbar spine surgery.
Description
Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire.
Time Frame
Baseline, 30 days
Secondary Outcome Measure Information:
Title
Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.
Description
Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery as measured by questionnaire.
Time Frame
Baseline, 30 days
Title
Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire.
Description
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).
Time Frame
Baseline, 30 days
Title
Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire.
Description
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).
Time Frame
Baseline, 30 days
Other Pre-specified Outcome Measures:
Title
Change in patient satisfaction levels within 30 days post-lumbar spine surgery.
Description
Change in patient satisfaction levels within 30 days post-lumbar spine surgery as measured by questionnaire.
Time Frame
Baseline, 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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? Exclusion Criteria: Prior lumbar fusions Tumors/infection/trauma Prisoners or institutionalized patients Non-English speaking patients Patients who smokes or with uncontrolled diabetes 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia E Pamanes, MPH
Phone
(919) 668-0897
Email
claudia.pamanes@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oren N Gottfried, MD FAANS
Organizational Affiliation
Duke Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Neurosurgery and Duke Orthopedics
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia E Pamanes, MPH
Phone
919-668-0897
Email
claudia.pamanes@duke.edu
First Name & Middle Initial & Last Name & Degree
Beth Perry, RN, CCRP
Phone
(919) 681-2695
Email
beth.perry@duke.edu
First Name & Middle Initial & Last Name & Degree
Oren N Gottfried, MD FAANS

12. IPD Sharing Statement

Plan to Share IPD
No

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

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