- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03473353
Doctor-Parent Interactions With Medical Scribes
January 9, 2023 updated by: Benjamin H. Levi, Milton S. Hershey Medical Center
The purpose of the study is to collect outcomes related to a quality improvement project assessing the feasibility and effectiveness of a medical scribe program in which medical scribes accompany clinicians during their visits with patients.
The medical scribes involved in the project are professional scribes and medical students who will accompany clinicians during patient visits and takes notes, enabling the clinician to engage more directly with the patient.
Study Overview
Detailed Description
The study has several specific objectives.
This study aims to examine the impact of using medical scribes on (1) patient experience (e.g.
patient satisfaction) (2) clinician experience (e.g.
stress load, burnout, evaluation of the visit, amount of time spent after hours inputting notes), and (3) clinician-patient interaction (e.g.
patient and clinician engagement during the visit).
Study Type
Interventional
Enrollment (Actual)
732
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
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Hope Drive Pediatric Clinic
-
-
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
Provider Participants
Inclusion Criteria:
- Attending clinicians with privileges at Penn State Hershey Children's Hospital and/or the Penn State Hershey Internal Medicine. This may include attending MDs or DOs and Nurse Practitioners (NPs).
- Voluntary participation in the medical scribe QI project.
- Consents to participate in the study.
Exclusion Criteria:
- Clinician is not participating in the scribe project.
- Clinician does not consent to participate in the research portion of this project.
Patient Participants
Inclusion Criteria:
- Patient (if 18 years or older) or parent/guardian (P/G) of patient being seen by a participating clinician.
- Patient was not seen by a resident or medical student prior to meeting with clinician.
- English speaking/reading.
- Patient or P/G has capacity to consent.
Exclusion Criteria:
- Patient is seeing a clinician who has not consented to participate in the research portion of the study.
- Non-English speaking/reading.
- Patient or P/G lacks capacity to consent.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Pediatric Clinicians
Survey data will be gathered from pediatric clinicians and also parents of pediatric patients at two time periods.
At baseline, no Medical Scribes will be working with the clinicians, and then several months later, data will be gathered when Medical scribes ARE working with clinicians.
|
Trained Medical Scribes will be present in the exam room to take notes on the the electronic medical record so that clinicians can focus all their attention to the interaction with the patient and parent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician Burnout
Time Frame: 1 year
|
Survey questions will assess clinician burnout using validated measures.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Levi, M.D., Ph.D., Departments of Humanities & Pediatrics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 30, 2017
Primary Completion (Actual)
June 29, 2018
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
March 15, 2018
First Submitted That Met QC Criteria
March 21, 2018
First Posted (Actual)
March 22, 2018
Study Record Updates
Last Update Posted (Estimate)
January 10, 2023
Last Update Submitted That Met QC Criteria
January 9, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00007664
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The study PI will share our study protocol, instruments, and published papers (which include our analytic approach).
IPD Sharing Time Frame
Study information will be shared upon request to the study PI (Levi), and will be available through 6-30-26.
IPD Sharing Access Criteria
Any interested researcher should contact the PI at: BHLevi@psu.edu.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
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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