Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis (LESSER)
31. marts 2017 opdateret af: Janna Friedly, University of Washington
Spinal stenosis is one of the most common causes of low back pain among older adults and can result in significant disability.
Despite this, it still isn't known which treatments are most effective or what outcomes are most important to these older adults.
Through a Patient Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS trial) to address several critical research questions.
The proposed study will answer the following key questions.
Do decision aids tailored to older adults with spinal stenosis change patient decision-making regarding subsequent treatments?
Do patients respond differently at subsequent outcome assessments time-points after receiving tailored decision aids that contain their own individual outcome data from prior treatments?
The investigators hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
LESS trial participants will be randomized to receive the individualized outcome report before the 18-month interview or after the 24-month follow up.
Both groups will be asked to rank outcome domains of most importance to them, to answer questions regarding their beliefs about receiving future treatments for spinal stenosis and to complete the standard self-reported outcomes questionnaire.
In addition, we will ask the study participants whether the information presented in the individualized report was helpful in deciding their future epidural injection treatments as well as if the content of the reports was easy to understand.
At 24 months, we will repeat the interview and the outcomes assessment.
We will again compare the groups in terms of their responses to determine if there are lasting differences in how patients who received the individualized reports make decisions regarding future treatments and respond to the self-reported outcomes questions.
In addition, we will compare healthcare utilization between the two groups from 18 months to 24 months to determine if providing the individualized outcomes reports changed treatment utilization (i.e., do people who receive the report undergo fewer subsequent injections or other treatments for pain?).
We hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
165
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98104
- University of Washington
-
-
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
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Patients already enrolled in the LESS trial will be eligible for participation in the LESSER trial
Exclusion Criteria:
none
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Individualized report
Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial.
They will receive these reports at 18 months.
|
Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)
|
|
Ingen indgriben: Individualized Reports after 24 months
Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months.
They will serve as the control group.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Utilization of ESI
Tidsramme: 24 months
|
We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months
|
24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Healthcare Utilization
Tidsramme: 24 months
|
We will determine if providing individualized reports to the LESS trial participants at 198 months impacts healthcare utilization for spinal stenosis between 18 and 24 months (including doctors visits, physical therapy, surgery, opioid use)
|
24 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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
1. oktober 2013
Primær færdiggørelse (Faktiske)
1. juli 2015
Studieafslutning (Faktiske)
1. september 2015
Datoer for studieregistrering
Først indsendt
5. oktober 2014
Først indsendt, der opfyldte QC-kriterier
8. oktober 2014
Først opslået (Skøn)
9. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 39023
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