Back to resultsDisjunction Between Patient Narrative and Formulaic Thinking in the Doctor
Primary Purpose
Musculoskeletal Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Story checklist
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Diseases focused on measuring Orthopedics
Eligibility Criteria
Inclusion Criteria:
- New patients
- Orthopedic visit
Exclusion Criteria:
- Languages other than English or Spanish.
- Cognitive dysfunction precluding completion of questionnaires.
Sites / Locations
- Austin Regional Clinic
- Texas Orthopedics
- HTB Musculoskeletal Institute
- Orthopedic Specialists of Austin
- ATX Ortho
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
Story checklist
Arm Description
Clinician not given any cards about the patient's story.
Clinician given a card with talking points in the form of a checklist about the patient's story.
Outcomes
Primary Outcome Measures
Patient Experience Measure questions
Questionnaire assessing patient's experience
Secondary Outcome Measures
Perceived empathy (JSPPPE)
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.
Guttman
Patient Satisfaction as measured by the Guttman Scale, The total score is between 0 and 7, with higher scores indicating greater satisfaction.
Guttman CEQ
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.
PROMIS PF CAT
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
NRS pain intensity assessment
Numeric rating scale = 11 point ordinal scale, the higher score indicates the more pain intensity
Full Information
NCT ID
NCT05401981
First Posted
May 11, 2022
Last Updated
May 27, 2022
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT05401981
Brief Title
Disjunction Between Patient Narrative and Formulaic Thinking in the Doctor
Official Title
Disjunction Between Patient Narrative and Formulaic Thinking in the Doctor
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
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
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
Keywords
Orthopedics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will randomly be assigned to 2 groups of intervention (The clinician receives the check list) and control (The clinician doesn't receive a checklist). After the visit patients will answer to questionnaires .
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Clinician not given any cards about the patient's story.
Arm Title
Story checklist
Arm Type
Experimental
Arm Description
Clinician given a card with talking points in the form of a checklist about the patient's story.
Intervention Type
Other
Intervention Name(s)
Story checklist
Intervention Description
The story checklist consists of a couple of questions that gives the physician something to keep in mind while visiting the patients.
Primary Outcome Measure Information:
Title
Patient Experience Measure questions
Description
Questionnaire assessing patient's experience
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Perceived empathy (JSPPPE)
Description
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.
Time Frame
through study completion, an average of 6 months
Title
Guttman
Description
Patient Satisfaction as measured by the Guttman Scale, The total score is between 0 and 7, with higher scores indicating greater satisfaction.
Time Frame
through study completion, an average of 6 months
Title
Guttman CEQ
Description
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.
Time Frame
through study completion, an average of 6 months
Title
PROMIS PF CAT
Description
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
Time Frame
through study completion, an average of 6 months
Title
NRS pain intensity assessment
Description
Numeric rating scale = 11 point ordinal scale, the higher score indicates the more pain intensity
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New patients
Orthopedic visit
Exclusion Criteria:
Languages other than English or Spanish.
Cognitive dysfunction precluding completion of questionnaires.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sina Ramtin, MD
Phone
5128276809
Email
sina.ramtin@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amirreza Fatehi, MD
Phone
5126577939
Email
Amirreza.Fatehi@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ring, MD, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Orthopedics
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
HTB Musculoskeletal Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Facility Name
Orthopedic Specialists of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
ATX Ortho
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Disjunction Between Patient Narrative and Formulaic Thinking in the Doctor
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