- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04154462
Evaluation of the Use of Medical Scribes in VAMC Emergency Departments and Specialty Care Clinics
Evaluation of the Use of Medical Scribes on Provider Efficiency, Patient Satisfaction, and Wait Times in VAMC Emergency Departments and Specialty Care Clinics
Background and study aims: Medical scribes are trained paraprofessionals that assist providers with documenting patient encounters. Prior evidence suggests that scribes may be effective in increasing provider productivity and satisfaction, and decreasing provider time spent on documentation without negatively affecting patient satisfaction. Section 507 of the MISSION Act of 2018 mandated a two-year pilot of medical scribes, which will begin in March 2020 in specialty clinics and emergency departments (EDs) of twelve VA Medical Centers (VAMCs) across the country. The aims of this study are to understand how the introduction of scribes and scribe training affect provider efficiency, patient and provider satisfaction, wait times, and daily patient volume in the VA context.
Who can participate? Urban and rural VAMCs willing to be assigned medical scribes for use in EDs or selected high wait time specialty clinics (cardiology, orthopedics).
What does the study involve? Four medical scribes will be assigned to each of the 12 VAMC sites randomized into treatment with the VA hiring half as new employees and contracting out for the remaining half. 30% of the scribes will be assigned to emergency departments and the other 70% will be assigned to specialty care. Remaining sites that expressed interest in the pilot but were not randomized treatment will be used as comparators. Provider productivity, patient volume, wait times, and patient satisfaction from the treated sites will be compared to baseline (pre-scribe) data as well as data from comparison sites.
What are the possible benefits and risks of participating? VAMCs where medical scribes are introduced may see gains in provider efficiency, reduced wait times, and increased patient satisfaction due to the shifting of administrative burdens associated with documenting patient encounters in electronic health records from providers to these trained professionals. The introduction of medical scribes could complicate patient encounters by making some patients and/or providers uncomfortable.
Where is the study run from? This study is being coordinated by the Partnered Evidence-based Policy Resource Center (PEPReC) at the VA Boston Healthcare System in collaboration with the VA Office of Veterans Access to Care (OVAC).
When is the study starting and how long is it expected to run for? March 2020 to February 2022
Who is funding the study? U.S. Veterans Health Administration
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85723
- Southern Arizona VA Health Care System
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Kentucky
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Louisville, Kentucky, United States, 40206
- Robley Rex VA Medical Center
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Maine
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Augusta, Maine, United States, 04330
- Togus Va Medical Center
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Montana
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Helena, Montana, United States, 59636
- Fort Harrison VA Medical Center
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New Hampshire
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Manchester, New Hampshire, United States, 03104
- Manchester VA Medical Center
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New Jersey
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East Orange, New Jersey, United States, 07018
- East Orange VA Medical Center
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North Dakota
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Fargo, North Dakota, United States, 58102
- Fargo VA Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma City VA Medical Center
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Texas
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San Antonio, Texas, United States, 78229
- Audie L. Murphy VA Hospital
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Temple, Texas, United States, 76504
- Olin E. Teague Veterans' Medical Center
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Virginia
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Hampton, Virginia, United States, 23667
- Hampton VA Medical Center
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West Virginia
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Clarksburg, West Virginia, United States, 26301
- Louis A. Johnson VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Expression of interest by VAMC
Exclusion Criteria:
• Lack of appropriate site capabilities
The VA Office of Veterans Access to Care developed a list of 32 interested VAMCs based on email surveying, which were categorized based on location (urban, rural), desired scribe deployment (ED, specialty care), and underserved (based on high new patient specialty care wait times). 12 VAMCs were then randomly selected for the treatment, accounting for the requirements of the law, OVAC preferences, and site capabilities, with the remainder used as comparison sites.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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NO_INTERVENTION: No intervention
The VAMC sites randomized to the comparison arm will not have medical scribes introduced into emergency departments or specialty clinics.
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EXPERIMENTAL: Treatment
The VAMC sites randomized to the treatment arm are each expected to have four medical scribes, with two being VA employees and two being contractors, introduced into emergency departments or specialty clinics to assist providers during patient encounters.
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Section 507 of the MISSION Act of 2018 mandates a two-year pilot of medical scribes in VA specialty clinics and emergency departments.
Medical scribes assist health care providers by helping to administratively expedite an episode of care through the recording of patient information and updating patient records.
Scribes are trained but non-licensed professionals, often deployed in emergency departments and outpatient clinic settings, that observe and document patient encounters but do not participate in clinical care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pay period work relative value-based provider efficiency
Time Frame: Approximately 42 months
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Pay period work relative value-based provider efficiency is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
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Approximately 42 months
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Pay period visit-based provider efficiency
Time Frame: Approximately 42 months
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Pay period visit-based provider efficiency is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
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Approximately 42 months
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Daily visit-based provider efficiency
Time Frame: Approximately 42 months
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Daily visit-based provider efficiency is measured using monthly-based provider efficiency, scaled by full-time-equivalent days; this is based on administrative data collected by the VA Corporate Data Warehouse in pay period increments
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Approximately 42 months
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Days to completed consult
Time Frame: Approximately 42 months
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Days to completed consult is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
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Approximately 42 months
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Days to scheduled consult
Time Frame: Approximately 42 months
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Days to scheduled consult is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
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Approximately 42 months
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Unique patient volume
Time Frame: Approximately 42 months
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Unique patient volume is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
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Approximately 42 months
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Patient satisfaction
Time Frame: Approximately 42 months
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Patient satisfaction is measured using V-Signals survey data collected by the VA Office of Veterans Experience in pay period increments
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Approximately 42 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven Pizer, PhD, Boston VA Healthcare System
Publications and helpful links
General Publications
- Pearson, E., Frakt, A., & Pizer, S. (2018, December). Medical Scribes, Productivity, and Satisfaction. Partnered Evidence-based Policy Resource Center Policy Brief, 3(2).
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEPReC Protocol #2019-001
- VA QUERI PEC #16-001 (OTHER_GRANT: VA QUERI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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