Analyzing Challenging Clinical Discussions in Orthopaedics
Primary Purpose
Teach-Back Communication, Arthritis, Knee Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teach-Back Lesson
Sponsored by
About this trial
This is an interventional health services research trial for Teach-Back Communication
Eligibility Criteria
Inclusion Criteria (Patient Participants):
- Age 18 years and older
- Clinical indication for multiple treatment options
Exclusion Criteria (Patient Participants):
- Non-English speaking
- Minors or non-consenting other individuals (spouses, friends, family members, children) in the patient room during the clinical visit
Inclusion Criteria (Provider Participants)
- Age 18 years and older
- A resident, fellow, physician assistant, or attending in the Duke Department of Orthopaedic Surgery
Exclusion criterion (Provider Participants):
• Non-English speaking
Sites / Locations
- Duke University Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Teach-Back Group
Arm Description
A teach-back lesson will be provided to physician participants (Teach-Back Group), who are participating in challenging clinical discussions with patients
Outcomes
Primary Outcome Measures
Provider's uninterrupted utterances
We will assess this outcome directly from audio-recorded conversations. A coding scheme will then be developed that captures the average length of provider utterance without asking a question or an interruption from a patient
Patient/provider talking ratio
This outcome will also be assessed from audio-recorded conversations. The transcript will be coded and the coding scheme will compare how often and how long patients talk compared to provider talking.
Secondary Outcome Measures
Providers perceptions about teach-back
This outcome will be assessed via semi-structured interviews.
Providers belief of future use of teach-back
This outcome will be assessed via the semi-structured interview
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03058393
Brief Title
Analyzing Challenging Clinical Discussions in Orthopaedics
Official Title
Effectiveness of Teach-back in Orthopedic Treatment Decision Discussions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Extenuating circumstances
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
November 7, 2018 (Actual)
Study Completion Date
November 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to analyze patient:provider communication surrounding the discussion of difficult clinical conversations such as knee replacement options. This study will also examine how using the teach-back communication technique can improve communication between patients and providers. Orthopedic residents, fellows, physician assistants, and attendings that agree to participate will be consented. Patients, who are likely to engage in a difficult clinical conversation, such as those who have a clinical indication for a Total Knee Replacement or a Partial Knee Replacement, will be recruited from participating providers clinical schedules. Patient:provider interactions will be recorded and then the providers will attend a 1 hour education lecture about how to use teach-back. After attending the lecture, additional patient:provider interactions will be recorded and analyzed via a qualitative approach. Additionally, providers will participate in a semi-structured interview to capture their perceptions of teach-back and what challenges and benefits they may derive from using it.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teach-Back Communication, Arthritis, Knee Osteoarthritis, Knee Arthropathy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teach-Back Group
Arm Type
Experimental
Arm Description
A teach-back lesson will be provided to physician participants (Teach-Back Group), who are participating in challenging clinical discussions with patients
Intervention Type
Other
Intervention Name(s)
Teach-Back Lesson
Intervention Description
A teach-back lesson will be given to providers (teach-back group) who have challenging clinical discussions with patients
Primary Outcome Measure Information:
Title
Provider's uninterrupted utterances
Description
We will assess this outcome directly from audio-recorded conversations. A coding scheme will then be developed that captures the average length of provider utterance without asking a question or an interruption from a patient
Time Frame
End of discussion with patient, 20 minutes
Title
Patient/provider talking ratio
Description
This outcome will also be assessed from audio-recorded conversations. The transcript will be coded and the coding scheme will compare how often and how long patients talk compared to provider talking.
Time Frame
End of discussion with patient, 20 minutes
Secondary Outcome Measure Information:
Title
Providers perceptions about teach-back
Description
This outcome will be assessed via semi-structured interviews.
Time Frame
End of semi-structured interview, one hour
Title
Providers belief of future use of teach-back
Description
This outcome will be assessed via the semi-structured interview
Time Frame
End of semi-structured interview, one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Patient Participants):
Age 18 years and older
Clinical indication for multiple treatment options
Exclusion Criteria (Patient Participants):
Non-English speaking
Minors or non-consenting other individuals (spouses, friends, family members, children) in the patient room during the clinical visit
Inclusion Criteria (Provider Participants)
Age 18 years and older
A resident, fellow, physician assistant, or attending in the Duke Department of Orthopaedic Surgery
Exclusion criterion (Provider Participants):
• Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard C Mather III, MD, MBA
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analyzing Challenging Clinical Discussions in Orthopaedics
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