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Writing Down Goals

Primary Purpose

Musculoskeletal Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Writing down goals
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Diseases focused on measuring decisional conflict, Orthopedics

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 8, 2021
    Last Updated
    June 17, 2021
    Sponsor
    University of Texas at Austin
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    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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