Doctor-Parent Interactions With Medical Scribes | NCT03473353

Studies
Doctor-Parent Interactions With Medical Scribes

NCT03473353

Sponsor

Milton S. Hershey Medical Center

Status

Completed

Last Update Posted

Jan 10, 2023Actual

Enrollment

732Actual

Phase

Not Applicable

Conditions

Burnout, Professional

Interventions

Medical Scribe

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2017Actual

Primary Completion Date

Jun 29, 2018Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Mar 15, 2018

First Submission Date that Met QC Criteria

Mar 21, 2018

First Posted Date

Mar 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2023

Last Update Posted Date

Jan 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

732Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Medical Scribe	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinician Burnout	Survey questions will assess clinician burnout using validated measures.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Benjamin Levi, M.D., Ph.D.	Departments of Humanities & Pediatrics	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hope Drive Pediatric Clinic		Hershey	Pennsylvania	17033	United States

Label	URL
Manuscript on impact of scribe intervention on documentation	View source
Manuscript on impact of scribe intervention on relative value units (RVUs)	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002055	Burnout, Professional

Ancestor Terms

ID	Term
D000073397	Occupational Stress
D009784	Occupational Diseases
D000077062	Burnout, Psychological
D013315	Stress, Psychological

Browse Leaves

Not provided

Browse Branches

Not provided