Duke Neurosurgery and Duke Orthopedics
Durham, North Carolina, 27710, United States
Location status: Recruiting
Location contact
Beth Perry, RN, CCRP
CONTACT
Claudia E Pamanes, MPH
CONTACT
Oren N Gottfried, MD FAANS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04140344
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Location status: Recruiting
Beth Perry, RN, CCRP
CONTACT
Claudia E Pamanes, MPH
CONTACT
Oren N Gottfried, MD FAANS
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Guidance via text messaging to lumbar spine surgery patients post-operatively
Time frame: Baseline, 30 days
Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire.
Time frame: Baseline, 30 days
Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery as measured by 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).
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).
Time frame: Baseline, 30 days
Change in patient satisfaction levels within 30 days post-lumbar spine surgery as measured by questionnaire.
Contact information is provided by the study sponsor or research team.
Duke University
Other
Acronym: NOTICE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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