NCT03473353

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
732

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

March 15, 2018

Last Update Submit

January 9, 2023

Conditions

Keywords

Medical ScribeOutpatientEHR

Outcome Measures

Primary Outcomes (1)

  • Clinician Burnout

    Survey questions will assess clinician burnout using validated measures.

    1 year

Study Arms (1)

Pediatric Clinicians

OTHER

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.

Other: Medical Scribe

Interventions

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.

Pediatric Clinicians

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Clinician is not participating in the scribe project.
  • Clinician does not consent to participate in the research portion of this project.
  • Patient Participants
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hope Drive Pediatric Clinic

Hershey, Pennsylvania, 17033, United States

Location

Related Links

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Benjamin Levi, M.D., Ph.D.

    Departments of Humanities & Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Departments of Humanities & Pediatrics

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 22, 2018

Study Start

September 30, 2017

Primary Completion

June 29, 2018

Study Completion

December 31, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

The study PI will share our study protocol, instruments, and published papers (which include our analytic approach).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Study information will be shared upon request to the study PI (Levi), and will be available through 6-30-26.
Access Criteria
Any interested researcher should contact the PI at: BHLevi@psu.edu.

Locations