- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04338425
Patient Satisfaction With Postoperative Communication Modality
April 8, 2020 updated by: NYU Langone Health
Communication between a surgeon and a patient in the immediate postoperative period is thought to influence patient satisfaction.
There is currently no standard of care regarding the optimal form of postoperative communication, nor is there a consensus in our department as to which modality is preferred by patients.The purpose of this study is to determine which form of communication, if any, is preferred by patients.
Furthermore, this study aims to evaluate the impact that various forms of communication during the immediate postoperative period have on patient (subject) satisfaction.
The study hypothesizes that patient (subject) satisfaction with their surgeon will be highest among those who communicate with their surgeons via videotelephony (i.e., videoconferencing) and that the lowest satisfaction will be among patients (subjects) who did not communicate with their surgeon until their regularly scheduled postoperative office visit.
The results of this study may help identify low cost methods for increasing patient satisfaction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, randomized study designed to evaluate the effects of different communication modalities between surgeons and patients (subjects) in the immediate postoperative period.
Given the nature of the study, it is not possible for either the surgeons or the subjects to be blinded.
To reduce bias that may occur due to each surgeon's personal preference for postoperative communication modality, the surgeons (rather than individual subjects) will be randomized to one of the three communication modality groups (no communication on the day of surgery, voice call, or videoconferencing).
Study Type
Interventional
Enrollment (Actual)
295
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
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- undergoing surgery at the NYU Langone Orthopedic Center
Exclusion Criteria:
- Under the age of 18 years old
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: No Communication group
Participants will not communicate with their surgeons until the post operative office visit.
|
|
ACTIVE_COMPARATOR: Voice call group
Participants will receive voice call from the surgeon after being discharged and before their post operative office visit.
|
Attending surgeons will contact with their patients on the day of surgery after discharge via voice call.
|
ACTIVE_COMPARATOR: Video call group
Participants will receive video call from surgeon after being discharged and before their post operative office visit
|
Attending surgeons will contact with their patients on the day of surgery after discharge via video call (video conferencing application such as FaceTime or Skype)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of participants' satisfaction with surgeon
Time Frame: post operative office visit (1 week after surgery)
|
The first self reported survey is designed specifically for this study to assess participants' satisfaction with their experience and postoperative communication.
|
post operative office visit (1 week after surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of participants' satisfaction with hospital experience
Time Frame: post operative office visit (1 week after surgery)
|
The second self reported survey contains questions from the standard HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey, which has been validated and used extensively to assess subject satisfaction with hospital experience.
|
post operative office visit (1 week after surgery)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2018
Primary Completion (ACTUAL)
June 30, 2019
Study Completion (ACTUAL)
July 20, 2019
Study Registration Dates
First Submitted
April 6, 2020
First Submitted That Met QC Criteria
April 6, 2020
First Posted (ACTUAL)
April 8, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 10, 2020
Last Update Submitted That Met QC Criteria
April 8, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 18-01489
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data and upon reasonable request.
Requests should be directed to matthew.kingery@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- 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
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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