- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04343027
Patient Satisfaction in the Orthopedic Surgery Clinic
December 2, 2022 updated by: NYU Langone Health
Patients in the orthopedic surgery clinic routinely fill out a patient- reported outcome measurement survey prior to their visit.
These scores are stored in Epic, but are not routinely reviewed with patients during their office visit.
Study subjects will be randomly assigned into one of two groups: those who have their patient- reported outcome measurements reviewed with them by their physician, and those who will not have their patient-reported outcome measurements reviewed during the visit.
Following the visit, patients will complete a patient satisfaction survey.
Study Overview
Detailed Description
This patient satisfaction survey is a modified version of the Press-Ganey Outpatient Medical Practice 10-question survey.
The patient satisfaction survey scores will then be compared between the two groups to quantify the effect of reviewing of patient-reported outcome measurements with patients on their satisfaction with the office visit
Study Type
Interventional
Phase
- Not Applicable
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 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients
- Ages 18 and 100 years
- Men and women will be included in this study
- Willing and able to provide consent
- Able to communicate in English
- All patients of the Principal Investigator(s) that have an clinic appointment during the study date range will be considered for inclusion in the study
Exclusion Criteria:
- Patients whose visit is related to workman's compensation, a disability claim, or a "no-fault" case (i.e. a law suit related to personal injury)
- Patients that do not complete the patient satisfaction survey following their visit
- Patient with mental disabilities or other handicap that would interfere with their capability of completing the surveys
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of care group
Participants who did not have their physicians review their patient-reported outcome measurements with them during the office visit.
|
|
|
Experimental: Consultation group
Participants who had their physicians review their patient-reported outcome measurements reviewed with them during the office visit.
|
Physicians will review patient-reported outcome measurements with their patients during office visits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in participants' satisfaction
Time Frame: 1 day (Visit 1)
|
Participants' satisfaction will be measured by completing a patient satisfaction survey.
This patient satisfaction survey is a modified version of the Press-Ganey Outpatient Medical Practice 10-question survey.
The patient satisfaction survey scores will then be compared between the two groups to quantify the effect of reviewing of patient-reported outcome measurements with patients on their satisfaction with the office visit.
|
1 day (Visit 1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Rokito, MD, NYU Langone Health
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 (Anticipated)
August 1, 2022
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
April 9, 2020
First Submitted That Met QC Criteria
April 10, 2020
First Posted (Actual)
April 13, 2020
Study Record Updates
Last Update Posted (Estimate)
December 6, 2022
Last Update Submitted That Met QC Criteria
December 2, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 20-00152
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Upon reasonable request.
Requests should be directed to andrew.rokito@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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