- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04947878
Development and Validation of an Orthopedic Visit Prompt List
September 27, 2021 updated by: David Ring, University of Texas at Austin
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
128
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 Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- UT Health Austin
-
-
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
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients (18+)
- Orthopedic visit
Exclusion Criteria:
- Patients who are illiterate.
- Patients who do not speak English.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard care
will not review a prompt list before their visit.
|
|
|
Experimental: Prompt list
The patients in the intervention group will review a prompt list before their visit.
|
The patients in the intervention group will review a prompt list before their visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decisional Conflict Scale
Time Frame: Baseline
|
Questionnaire assessing decision conflict
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jefferson Scale of Patient's Perceptions of Physician Empathy
Time Frame: Baseline
|
Patient perceived of physician empathy as measured by the JSPPE
|
Baseline
|
|
Patient Activation Measure-13
Time Frame: Baseline
|
Patient activation as measured by PAM-13
|
Baseline
|
|
Satisfaction scale
Time Frame: Baseline
|
Questionnaire measuring to what degree patients are satisfied with the care they received.
|
Baseline
|
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 (Actual)
July 1, 2021
Primary Completion (Actual)
August 1, 2021
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
June 13, 2021
First Submitted That Met QC Criteria
June 23, 2021
First Posted (Actual)
July 1, 2021
Study Record Updates
Last Update Posted (Actual)
September 28, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-02-0122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.