- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03058393
Analyzing Challenging Clinical Discussions in Orthopaedics
December 16, 2019 updated by: Duke University
Effectiveness of Teach-back in Orthopedic Treatment Decision Discussions
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Teach-Back Group
A teach-back lesson will be provided to physician participants (Teach-Back Group), who are participating in challenging clinical discussions with patients
|
A teach-back lesson will be given to providers (teach-back group) who have challenging clinical discussions with patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider's uninterrupted utterances
Time Frame: End of discussion with patient, 20 minutes
|
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
|
End of discussion with patient, 20 minutes
|
Patient/provider talking ratio
Time Frame: End of discussion with patient, 20 minutes
|
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.
|
End of discussion with patient, 20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Providers perceptions about teach-back
Time Frame: End of semi-structured interview, one hour
|
This outcome will be assessed via semi-structured interviews.
|
End of semi-structured interview, one hour
|
Providers belief of future use of teach-back
Time Frame: End of semi-structured interview, one hour
|
This outcome will be assessed via the semi-structured interview
|
End of semi-structured interview, one hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard C Mather III, MD, MBA, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2017
Primary Completion (Actual)
November 7, 2018
Study Completion (Actual)
November 7, 2018
Study Registration Dates
First Submitted
February 14, 2017
First Submitted That Met QC Criteria
February 16, 2017
First Posted (Actual)
February 20, 2017
Study Record Updates
Last Update Posted (Actual)
December 17, 2019
Last Update Submitted That Met QC Criteria
December 16, 2019
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00079809
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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