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Development and Validation of an Orthopedic Visit Prompt List

Primary Purpose

Musculoskeletal Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prompt list
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 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

  • UT health Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

Prompt list

Arm Description

will not review a prompt list before their visit.

The patients in the intervention group will review a prompt list before their visit.

Outcomes

Primary Outcome Measures

Decisional Conflict Scale
Questionnaire assessing decision conflict

Secondary Outcome Measures

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
Satisfaction scale
Questionnaire measuring to what degree patients are satisfied with the care they received.

Full Information

First Posted
June 13, 2021
Last Updated
September 27, 2021
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT04947878
Brief Title
Development and Validation of an Orthopedic Visit Prompt List
Official Title
Development and Validation of an Orthopedic Visit Prompt List
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

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
Investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.
Detailed Description
Visiting a doctor with a musculoskeletal problem can be quite a daunting experience for patients. A visit question prompt list may help to empower patients and increase their role in active decision-making. Previous studies have shown that patient activation is correlated with a disability, pain intensity, and satisfaction with treatment. Perceived empathy is strongly associated with satisfaction among people with arm problems. A list that prompts patients to ask about things that matter to them, might improve their connection with the surgeon and their perceived empathy. The investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.

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
All new, adult (18+ years old) patients seeing an orthopedic surgeon for a consultation will be invited to enroll. Randomization will be done through an Excel random number generator. The patients in the intervention group will review a prompt list before their visit. The research assistant will shadow the surgeon to count the amount of questions they ask during their visit. Patients in both groups will fill out a survey entailing demographics, the Decisional Conflict Scale, the JSPPE, the PAM score and a satisfaction scale at the end of the visit.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
will not review a prompt list before their visit.
Arm Title
Prompt list
Arm Type
Experimental
Arm Description
The patients in the intervention group will review a prompt list before their visit.
Intervention Type
Other
Intervention Name(s)
Prompt list
Intervention Description
The patients in the intervention group will review a prompt list before their visit.
Primary Outcome Measure Information:
Title
Decisional Conflict Scale
Description
Questionnaire assessing decision conflict
Time Frame
Baseline
Secondary Outcome Measure Information:
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
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.
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
UT health Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development and Validation of an Orthopedic Visit Prompt List

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