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

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Model

Knee Anatomy Video

Verbal

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Truman Medical Center and Dickson-Diveley Orthopaedic Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Verbal

Verbal + Model

Verbal + Video

Arm Description

This group will only receive a verbal discussion based on the same script used for all three groups. This is the control group.

This group will receive a verbal discussion aided with an anatomic model intervention that group participants will be able to touch throughout the discussion.

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.

Outcomes

Primary Outcome Measures

The Nkem Test

This knowledge based questionnaire assesses patient comprehension of an informed consent discussion. The score of the test is known as "The Nkem Score".

Secondary Outcome Measures

Full Information

NCT ID

NCT02694237

First Posted

February 18, 2016

Last Updated

April 28, 2016

Sponsor

University of Missouri, Kansas City

1. Study Identification

Unique Protocol Identification Number

NCT02694237

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Missouri, Kansas City

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Verbal

Arm Type

Active Comparator

Arm Description

This group will only receive a verbal discussion based on the same script used for all three groups. This is the control group.

Arm Title

Verbal + Model

Arm Type

Active Comparator

Arm 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.

Arm Title

Verbal + Video

Arm Type

Active Comparator

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Model

Intervention Description

Each participant will receive an informed consent discussion with the aid of an anatomic knee model.

Intervention Type

Behavioral

Intervention Name(s)

Knee Anatomy Video

Intervention Description

Each participant will hear a scripted informed consent discussion while they watch a knee anatomy video orated by an interviewer.

Intervention Type

Behavioral

Intervention Name(s)

Verbal

Intervention Description

Each participant will receive a verbal informed consent discussion without a visual aid.

Primary Outcome Measure Information:

Title

The Nkem Test

Description

This knowledge based questionnaire assesses patient comprehension of an informed consent discussion. The score of the test is known as "The Nkem Score".

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: