Writing Down Goals
Primary Purpose
Musculoskeletal Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Writing down goals
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Diseases focused on measuring decisional conflict, Orthopedics
Eligibility Criteria
Inclusion Criteria:
- Adult patients (18+)
- Orthopedic visit
Exclusion Criteria:
- Patients who are illiterate.
- Patients who do not speak English.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
Writing down goals
Arm Description
Will not write down goals their goals for their medical care (usual care).
Will write down goals their goals for their medical care.
Outcomes
Primary Outcome Measures
Decision conflict questionnaire
Questionnaire assessing decision conflict
Secondary Outcome Measures
Decision regret questionnaire
Questionnaire assessing the degree of regret of decision
Jefferson Scale of Patient's Perceptions of Physician Empathy
Patient perceived of physician empathy as measured by the JSPPE
Patient Activation Measure-13
Patient activation as measured by PAM-13
Guttman Satisfaction scale
Questionnaire measuring to what degree patients are satisfied with the care they received.
Full Information
NCT ID
NCT04932993
First Posted
June 8, 2021
Last Updated
June 17, 2021
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT04932993
Brief Title
Writing Down Goals
Official Title
Writing Down Goals
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
November 2021 (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
The women's health IPU at UT Health Austin is happy with having patients write down their goals at their first visit and then tracking those. It would be interesting to study people seeking musculoskeletal specialty care to determine whether asking patients what result of their care would be rated a success helps direct the clinician-patient interaction in a more fruitful direction compared to the usual clinical interaction.
Detailed Description
People's stated preferences are often inconsistent with what matters most to them (their values). And they are often based on misconceptions, distress, and less effective cognitive coping strategies. For instance, a person might say "My goal is to have no pain" when that is not possible. Or they might say "My goal is to get the shot that fixes this" when there is no such shot. It may go without saying that people want: "To be able to live a normal lifestyle" and "To be able to accomplish most of their goals." In other words, people want to be able to be themselves. They are seeking care because they are not able to be themselves or they are concerned that they may not be able to be themselves. The word health comes from an old German word meaning "whole."
One part of good health is correcting or alleviating pathophysiology (e.g. reading glasses). Another part of good health is evolving one's inner narrative (e.g. "I'm older now and need glasses to read").
The women's health IPU at UT Health Austin is happy with having patients write down their goals at their first visit and then tracking those. It would be interesting to study people seeking musculoskeletal specialty care to determine whether asking patients what result of their care would be rated a success helps direct the clinician-patient interaction in a more fruitful direction compared to the usual clinical interaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
Keywords
decisional conflict, Orthopedics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All new, adult (18+ years old) patients seeing an orthopedic surgeon for a consultation will be invited to participate in this study. Patients randomly will be assigned to: write down goals their goals for their medical care (intervention) or not (usual visit control group). The research assistant will ask the patient to fill out a survey entailing demographics, JSPPE, the communication effectiveness score, the PAM score and a satisfaction scale at the end of the visit. A research assistant will record the diagnosis,
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Will not write down goals their goals for their medical care (usual care).
Arm Title
Writing down goals
Arm Type
Experimental
Arm Description
Will write down goals their goals for their medical care.
Intervention Type
Behavioral
Intervention Name(s)
Writing down goals
Intervention Description
Patient will write their health goals down before the visit.
Primary Outcome Measure Information:
Title
Decision conflict questionnaire
Description
Questionnaire assessing decision conflict
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Decision regret questionnaire
Description
Questionnaire assessing the degree of regret of decision
Time Frame
Baseline
Title
Jefferson Scale of Patient's Perceptions of Physician Empathy
Description
Patient perceived of physician empathy as measured by the JSPPE
Time Frame
Baseline
Title
Patient Activation Measure-13
Description
Patient activation as measured by PAM-13
Time Frame
Baseline
Title
Guttman Satisfaction scale
Description
Questionnaire measuring to what degree patients are satisfied with the care they received.
Time Frame
Baseline
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:
Adult patients (18+)
Orthopedic visit
Exclusion Criteria:
Patients who are illiterate.
Patients who do not speak English.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amirreza Fatehi, MD
Phone
5126577939
Email
Amirreza.Fatehi@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sina Ramtin, MD
Phone
5128276809
Email
sina.ramtin@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ring, MD, PhD
Organizational Affiliation
Professor of Surgery, Dell Medical School at The University of Texas at Austin
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Writing Down Goals
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