Teach-Back CommunicationNCT03058393
Analyzing Challenging Clinical Discussions in Orthopaedics
A study testing Teach-Back Lesson in people with Teach-Back Communication and Arthritis, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Teach-Back Communication, Arthritis, Knee Osteoarthritis
- What is being tested?
- Teach-Back Lesson
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2017to 7 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Clinical indication for multiple treatment options
- Age 18 years and older
- A resident, fellow, physician assistant, or attending in the Duke Department of Orthopaedic Surgery
Who cannot join
- Non-English speaking
- Minors or non-consenting other individuals (spouses, friends, family members, children) in the patient room during the clinical visit
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: 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.
- Being tested
- Teach-Back Lesson
- Medical subject headings
- Teach-Back Communication, Arthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-Back LessonOther
A teach-back lesson will be given to providers (teach-back group) who have challenging clinical discussions with patients
| Study group | Role | What they receive |
|---|---|---|
| Teach-Back Group | Experimental | A teach-back lesson will be provided to physician participants (Teach-Back Group), who are participating in challenging clinical discussions with patients Receives: Other: Teach-Back Lesson |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of discussion with patient, 20 minutes
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.
Measured: End of discussion with patient, 20 minutes
Secondary outcomes (2)
Providers perceptions about teach-back
This outcome will be assessed via semi-structured interviews.
Measured: End of semi-structured interview, one hour
Providers belief of future use of teach-back
This outcome will be assessed via the semi-structured interview
Measured: End of semi-structured interview, one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start17 Apr 2017
- Primary completion7 Nov 2018
- Study completion7 Nov 2018
Why it stopped: Extenuating circumstances
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teach-Back CommunicationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard C Mather III, MD, MBA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058393
- Sponsor's protocol ID
- Pro00079809
- Status last verified
- Jun 2018
- First submitted
- 14 Feb 2017
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Teach-back in Orthopedic Treatment Decision Discussions
- ClinicalTrials.gov ID
- NCT03058393
- Acronym / sponsor ID
- Pro00079809
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extenuating circumstances
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teach-Back Group | Experimental | Other: Teach-Back LessonA teach-back lesson will be provided to physician participants (Teach-Back Group), who are participating in challenging clinical discussions with patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and older
- Clinical indication for multiple treatment options
- Age 18 years and older
- A resident, fellow, physician assistant, or attending in the Duke Department of Orthopaedic Surgery
Key exclusion criteria (3 listed)
- Non-English speaking
- Minors or non-consenting other individuals (spouses, friends, family members, children) in the patient room during the clinical visit
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teach-Back LessonA teach-back lesson will be given to providers (teach-back group) who have challenging clinical discussions with patients | Other | Teach-Back Group |
Primary outcome
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
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.
2 secondary outcomes
Providers perceptions about teach-back
Time frame: End of semi-structured interview, one hour
Providers belief of future use of teach-back
Time frame: End of semi-structured interview, one hour
Results and safety
The study was stopped early (reason given: Extenuating circumstances). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard C Mather III, MD, MBA principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach-Back Lesson in people with Teach-Back Communication and Arthritis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Extenuating circumstances). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider's uninterrupted utterances (time frame: End of discussion with patient, 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.