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NOTICE-undersøgelsen: Neurokirurgi og ortopædisk kommunikationsevalueringsundersøgelse efter lændefusioner (NOTICE)

2. november 2026 opdateret af: Duke University

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

224

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Rekruttering
        • Duke Neurosurgery and Duke Orthopedics
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Oren N Gottfried, MD FAANS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.

Andre navne:
  • Vejledning via sms til lændehvirvelopererede patienter postoperativt
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in readmission rates within 30 days post-lumbar spine surgery.
Tidsramme: Baseline, 30 days

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.
Tidsramme: Baseline, 30 days

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in patient satisfaction levels within 30 days post-lumbar spine surgery.
Tidsramme: Baseline, 30 days

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Duke University

Efterforskere

  • Ledende efterforsker: Oren N Gottfried, MD FAANS, Duke Neurosurgery

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. september 2023

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

24. oktober 2019

Først indsendt, der opfyldte QC-kriterier

24. oktober 2019

Først opslået (Faktiske)

25. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00103904

Plan for individuelle deltagerdata (IPD)

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