- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05401981
Disjunction Between Patient Narrative and Formulaic Thinking in the Doctor
May 27, 2022 updated by: David Ring, University of Texas at Austin
This study is seeking whether giving or not giving a clinician a card with talking points in the form of a checklist about the patient's story affects the patients care experience or not
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
During an office visit, the clinician and the patient engage in dialogue and begin a relationship.
This traditionally starts with the patient telling their story, which conveys why they decided to seek care.
This study will determine the influence of a checklist specifically about the patient's narrative.
The checklist will be used during the interview portion of the visit, to remind the clinician to stay curious about the person before them, their experience of the illness, and their explanatory model, and to help ensure that empathic opportunities are not missed.
Study Type
Interventional
Enrollment (Anticipated)
136
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 Contact
- Name: Amirreza Fatehi, MD
- Phone Number: 5126577939
- Email: Amirreza.Fatehi@austin.utexas.edu
Study Contact Backup
- Name: Sina Ramtin, MD
- Phone Number: 5128276809
- Email: sina.ramtin@austin.utexas.edu
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78705
- Austin Regional Clinic
-
Austin, Texas, United States, 78712
- HTB Musculoskeletal Institute
-
Austin, Texas, United States, 78751
- Orthopedic Specialists of Austin
-
Austin, Texas, United States, 78705
- Texas Orthopedics
-
Austin, Texas, United States, 78756
- ATX Ortho
-
-
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
16 years to 87 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- New patients
- Orthopedic visit
Exclusion Criteria:
- Languages other than English or Spanish.
- Cognitive dysfunction precluding completion of questionnaires.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care
Clinician not given any cards about the patient's story.
|
|
Experimental: Story checklist
Clinician given a card with talking points in the form of a checklist about the patient's story.
|
The story checklist consists of a couple of questions that gives the physician something to keep in mind while visiting the patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Experience Measure questions
Time Frame: through study completion, an average of 6 months
|
Questionnaire assessing patient's experience
|
through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived empathy (JSPPPE)
Time Frame: through study completion, an average of 6 months
|
Patient perceived of physician empathy as measured by the JSPPPE;The scores range from 1 ("Strongly Disagree") to 7 ("Strongly Agree"), with the total score being between 5 and 35.
Higher scores represent greater empathic perception about the physician.
|
through study completion, an average of 6 months
|
Guttman
Time Frame: through study completion, an average of 6 months
|
Patient Satisfaction as measured by the Guttman Scale, The total score is between 0 and 7, with higher scores indicating greater satisfaction.
|
through study completion, an average of 6 months
|
Guttman CEQ
Time Frame: through study completion, an average of 6 months
|
Communication Effectiveness Questionnaire; The total score is the sum of all item scores (9 to 63) with higher scores representing a greater degree of perceived communication effectiveness.
|
through study completion, an average of 6 months
|
PROMIS PF CAT
Time Frame: through study completion, an average of 6 months
|
Patient Physical Function is measure by the PROMIS PF CAT; Higher scores indicate better physical function, with a mean of 50 for the general US population
|
through study completion, an average of 6 months
|
NRS pain intensity assessment
Time Frame: through study completion, an average of 6 months
|
Numeric rating scale = 11 point ordinal scale, the higher score indicates the more pain intensity
|
through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Ring, MD, PhD, The University of Texas at Austin
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 (Anticipated)
June 1, 2022
Primary Completion (Anticipated)
November 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
May 11, 2022
First Submitted That Met QC Criteria
May 27, 2022
First Posted (Actual)
June 2, 2022
Study Record Updates
Last Update Posted (Actual)
June 2, 2022
Last Update Submitted That Met QC Criteria
May 27, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01-0115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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