The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent in a Private Practice

U

University of Missouri, Kansas City

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Behavioral: Knee Anatomy Video
Behavioral: Model
Behavioral: Verbal

Study type

Interventional

Funder types

Other

Identifiers

NCT02694237
OrthoInfo

Details and patient eligibility

About

The aim of the study is determine which method of informed consent improves comprehension in college educated patients in a private practice setting.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Knee osteoarthritis patients over the age of 18 with a college education deemed appropriate for medical management with a knee injection.

Exclusion criteria

  • Patients without the capacity to provide consent
  • Patients with a visual, auditory, psychological or tactile impairment requiring the assistance of another person.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

66 participants in 3 patient groups

Verbal
Active Comparator group
Description:
This group will only receive a verbal discussion based on the same script used for all three groups. This is the control group.
Treatment:
Behavioral: Verbal
Verbal + Model
Active Comparator group
Description:
This group will receive a verbal discussion aided with an anatomic model intervention that group participants will be able to touch throughout the discussion.
Treatment:
Behavioral: Model
Verbal + Video
Active Comparator group
Description:
This group will receive a verbal discussion aided with a knee anatomy video intervention that will be played on silent an orated by an interviewer.
Treatment:
Behavioral: Knee Anatomy Video

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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