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Evaluation of the Use of Medical Scribes in VAMC Emergency Departments and Specialty Care Clinics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154462
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Melissa Garrido, VA Boston Healthcare System

Tracking Information
First Submitted Date  ICMJE November 4, 2019
First Posted Date  ICMJE November 6, 2019
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
  • Pay period work relative value-based provider efficiency [ Time Frame: Approximately 42 months ]
    Pay period work relative value-based provider efficiency is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
  • Pay period visit-based provider efficiency [ Time Frame: Approximately 42 months ]
    Pay period visit-based provider efficiency is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
  • Daily visit-based provider efficiency [ Time Frame: Approximately 42 months ]
    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
  • Days to completed consult [ Time Frame: Approximately 42 months ]
    Days to completed consult is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
  • Days to scheduled consult [ Time Frame: Approximately 42 months ]
    Days to scheduled consult is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
  • Unique patient volume [ Time Frame: Approximately 42 months ]
    Unique patient volume is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
  • Patient satisfaction [ Time Frame: Approximately 42 months ]
    Patient satisfaction is measured using V-Signals survey data collected by the VA Office of Veterans Experience in pay period increments
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Use of Medical Scribes in VAMC Emergency Departments and Specialty Care Clinics
Official Title  ICMJE Evaluation of the Use of Medical Scribes on Provider Efficiency, Patient Satisfaction, and Wait Times in VAMC Emergency Departments and Specialty Care Clinics
Brief Summary

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A two-arm randomized field experiment is being used to assess the effect of medical scribes on productivity, wait times, and patient satisfaction. OVAC will work with participating VAMCs to identify providers to participate in the pilot. A varied provider pool will limit selection bias but must be balanced with recruitment and retention of providers. The goal is to keep the provider-scribe pairs consistent throughout the pilot.

Each VAMC site randomized to treatment will have two VA employee scribes and two contract scribes. Two medical scribes, ideally one employee and one contract, will be assigned to one physician, with two physicians and/or Licensed Independent Practitioners (LIP) participating at each facility. Scribes will work with others if the provider partner is not available during a scheduled shift. Power analyses have been conducted to determine the minimum effect size for each outcome with 80% power, which will be useful for putting the final results into context.

Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Medical Scribes
Intervention  ICMJE Other: Scribes
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.
Study Arms  ICMJE
  • No Intervention: No intervention
    The VAMC sites randomized to the comparison arm will not have medical scribes introduced into emergency departments or specialty clinics.
  • 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.
    Intervention: Other: Scribes
Publications * Pearson, E., Frakt, A., & Pizer, S. (2018, December). Medical Scribes, Productivity, and Satisfaction. Partnered Evidence-based Policy Resource Center Policy Brief, 3(2).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Steven Pizer, PhD (857) 364-6061 peprec@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04154462
Other Study ID Numbers  ICMJE PEPReC Protocol #2019-001
VA QUERI PEC #16-001 ( Other Grant/Funding Number: VA QUERI )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Melissa Garrido, VA Boston Healthcare System
Study Sponsor  ICMJE VA Boston Healthcare System
Collaborators  ICMJE US Department of Veterans Affairs
Investigators  ICMJE
Principal Investigator: Steven Pizer, PhD Boston VA Healthcare System
PRS Account VA Boston Healthcare System
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP