Medical ScribesNCT04154462
Evaluation of the Use of Medical Scribes in VAMC Emergency Departments and Specialty Care Clinics
A study testing Scribes in people with Medical Scribes, run by VA Boston Healthcare System at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Scribes
- What is being tested?
- Scribes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Mar 2019to 1 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Expression of interest by VAMC
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Togus VA Medical Center
Augusta, Maine, 04330
Louis A. Johnson VA Medical Center
Clarksburg, West Virginia, 26301
East Orange VA Medical Center
East Orange, New Jersey, 07018
Fargo VA Medical Center
Fargo, North Dakota, 58102
Hampton VA Medical Center
Hampton, Virginia, 23667
Fort Harrison VA Medical Center
Helena, Montana, 59636
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
Manchester VA Medical Center
Manchester, New Hampshire, 03104
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, 73104
Audie L. Murphy VA Hospital
San Antonio, Texas, 78229
Olin E. Teague Veterans' Medical Center
Temple, Texas, 76504
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
About this study
Official title: 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).
Read more
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
- Conditions
- Medical Scribes
- Being tested
- Scribes
- Keywords
- workforce, medical records, documentation, efficiency, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScribesOther
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 group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | The VAMC sites randomized to the comparison arm will not have medical scribes introduced into emergency departments or specialty clinics. |
| Treatment | Experimental | 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. Receives: Other: Scribes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pay period work relative value-based provider efficiency
Pay period work relative value-based provider efficiency is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
Measured: Approximately 42 months
Pay period visit-based provider efficiency
Pay period visit-based provider efficiency is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
Measured: Approximately 42 months
Daily visit-based provider efficiency
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
Measured: Approximately 42 months
Days to completed consult
Days to completed consult is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
Measured: Approximately 42 months
Days to scheduled consult
Days to scheduled consult is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
Measured: Approximately 42 months
Unique patient volume
Unique patient volume is measured using administrative data collected by the VA Corporate Data Warehouse in pay period increments
Measured: Approximately 42 months
Patient satisfaction
Patient satisfaction is measured using V-Signals survey data collected by the VA Office of Veterans Experience in pay period increments
Measured: Approximately 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Mar 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medical ScribesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Melissa Garrido, VA Boston Healthcare System
- Investigators
- Steven Pizer, PhD, Principal investigator, Boston VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154462
- Sponsor's protocol ID
- PEPReC Protocol #2019-001
- Other IDs
- VA QUERI PEC #16-001
- Status last verified
- Aug 2022
- First submitted
- 4 Nov 2019
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pearson, E., Frakt, A., & Pizer, S. (2018, December). Medical Scribes, Productivity, and Satisfaction. Partnered Evidence-based Policy Resource Center Policy Brief, 3(2).
Palani S, Saeed I, Legler A, Sadej I, MacDonald C, Kirsh SR, Pizer SD, Shafer PR. Effect of the Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act Scribes Trial on Emergency Department Provider Productivity and Patient Throughput Times. J Emerg Med. 2024 Jul;67(1):e89-e98. doi: 10.1016/j.jemermed.2024.03.036. Epub 2024 Mar 30.
PubMed 38824039Palani S, Saeed I, Legler A, Sadej I, MacDonald C, Kirsh SR, Pizer SD, Shafer PR. Effect of a National VHA Medical Scribe Pilot on Provider Productivity, Wait Times, and Patient Satisfaction in Cardiology and Orthopedics. J Gen Intern Med. 2023 Jul;38(Suppl 3):878-886. doi: 10.1007/s11606-023-08114-6. Epub 2023 Jun 20.
PubMed 37340268
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Medical Scribes on Provider Efficiency, Patient Satisfaction, and Wait Times in VAMC Emergency Departments and Specialty Care Clinics
- ClinicalTrials.gov ID
- NCT04154462
- Acronym / sponsor ID
- PEPReC Protocol #2019-001
- Conditions
- Medical Scribes
- Keywords
- workforce, medical records, documentation, efficiency, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 6 Nov 2019 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –The VAMC sites randomized to the comparison arm will not have medical scribes introduced into emergency departments or specialty clinics. |
| Treatment | Experimental | Other: ScribesThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Expression of interest by VAMC
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| ScribesSection 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. | Other | Treatment |
Primary outcome
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
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 30 Aug 2022.
- BackgroundPearson, E., Frakt, A., & Pizer, S. (2018, December). Medical Scribes, Productivity, and Satisfaction. Partnered Evidence-based Policy Resource Center Policy Brief, 3(2).
- Derived from this study: PubMed 38824039Palani S, Saeed I, Legler A, Sadej I, MacDonald C, Kirsh SR, Pizer SD, Shafer PR. Effect of the Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act Scribes Trial on Emergency Department Provider Productivity and Patient Throughput Times. J Emerg Med. 2024 Jul;67(1):e89-e98. doi: 10.1016/j.jemermed.2024.03.036. Epub 2024 Mar 30.
- Derived from this study: PubMed 37340268Palani S, Saeed I, Legler A, Sadej I, MacDonald C, Kirsh SR, Pizer SD, Shafer PR. Effect of a National VHA Medical Scribe Pilot on Provider Productivity, Wait Times, and Patient Satisfaction in Cardiology and Orthopedics. J Gen Intern Med. 2023 Jul;38(Suppl 3):878-886. doi: 10.1007/s11606-023-08114-6. Epub 2023 Jun 20.
- S.2372 - VA MISSION Act of 2018Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Steven Pizer, PhD principal investigator
Boston VA Healthcare System
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scribes in people with Medical Scribes, run by VA Boston Healthcare System at 12 sites 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 1 inclusion and 2 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 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Pay period work relative value-based provider efficiency (time frame: Approximately 42 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154462, which also lists 3 linked publications.
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 30 Aug 2022.