Burnout, ProfessionalNCT03473353
Doctor-Parent Interactions With Medical Scribes
A study testing Medical Scribe in people with Burnout, Professional, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Medical Scribe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2017to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- Clinician is not participating in the scribe project.
- Clinician does not consent to participate in the research portion of this project.
- Patient Participants
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hope Drive Pediatric Clinic
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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).
- Conditions
- Burnout, Professional
- Being tested
- Medical Scribe
- Keywords
- Medical Scribe, Outpatient, EHR
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical ScribeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Medical Scribe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Burnout
Survey questions will assess clinician burnout using validated measures.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start30 Sep 2017
- Primary completion29 Jun 2018
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin H. Levi, Milton S. Hershey Medical Center
- Investigators
- Benjamin Levi, M.D., Ph.D., Principal investigator, Departments of Humanities & Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473353
- Sponsor's protocol ID
- STUDY00007664
- Status last verified
- Jan 2023
- First submitted
- 15 Mar 2018
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study PI will share our study protocol, instruments, and published papers (which include our analytic approach).
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doctor-Parent Interactions With Medical Scribes
- ClinicalTrials.gov ID
- NCT03473353
- Acronym / sponsor ID
- STUDY00007664
- Conditions
- Burnout, Professional
- Keywords
- Medical Scribe, Outpatient, EHR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 732 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Clinicians | Other | Other: Medical ScribeSurvey 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (6 listed)
- Clinician is not participating in the scribe project.
- Clinician does not consent to participate in the research portion of this project.
- Patient Participants
- Patient is seeing a clinician who has not consented to participate in the research portion of the study.
- Non-English speaking/reading.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical ScribeTrained 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. | Other | Pediatric Clinicians |
Primary outcome
Clinician Burnout
Time frame: 1 year
Survey questions will assess clinician burnout using validated measures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Manuscript on impact of scribe intervention on documentationLink provided by the sponsor.
- Manuscript on impact of scribe intervention on relative value units (RVUs)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study PI will share our study protocol, instruments, and published papers (which include our analytic approach).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Levi, M.D., Ph.D. principal investigator
Departments of Humanities & Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Scribe in people with Burnout, Professional, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Burnout (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.