The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial.
In this study, the investigators aim to evaluate the impact of a visual aid on patient comprehension an orthopedic informed consent discussion in low socioeconomic populations.
The primary outcome is patient comprehension measured by a Validated Knowledge-Based Multiple Choice Questionnaire.
The secondary outcomes include: Patient satisfaction and Time efficiency.
The investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic informed consent discussion will improve patient comprehension, satisfaction and time-efficiency of orthopedic care.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients newly diagnosed with Knee Osteoarthritis managed with steroid injections
- Patients who express lack of knowledge regarding knee osteoarthritis (causes, diagnosis, treatment, anatomy)
- English speaking
- Patients that meet the Federal Poverty Guideline for Healthcare (i.e. Medicaid)
Exclusion Criteria:
- Patients under the age of 18
- College graduates
- Non-English speaking
- Patient without the capacity to give consent
- Patients with a tactile, mental, visual or auditory disability
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Verbal Discussion: Control Group
In this group, participants will receive a 10 minute Verbal Only Knee Osteoarthritis Steroid Injection Informed Consent discussion. This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection. |
|
|
Aktiv komparator: Verbal+Anatomic Model
This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Knee Model. This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection. |
|
|
Aktiv komparator: Verbal+Video Presentation
This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Video. This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The Nkem Test
Tidsramme: 20 minutes
|
Comprehension based examination of an informed consent discussion
|
20 minutes
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Patient Satisfaction Survey
Tidsramme: 5 minutes
|
5 minutes
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Nkem Egekeze, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY
- Studieleder: Karen Williams, PhD, UMKC DEPT OF BIOINFORMATICS
- Studiestol: Mark Bernhardt, MD, UMKC Department of Orthopaedic Surgery
- Studieleder: Johnathan Dubin, MD, UMKC Department of Orthopaedic Surgery
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14-334
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