Epic is the main electronic health record system (EHR) used at MSHS, to which MSHS is migrating its hospitals and practices.
- Clinical Trial Research Study Management
- Clinical Research Study Tools
- Cohort QueryTool
Access to the Epic Electronic Health Record System
The Mount Sinai Medical Board requires new hires to complete training prior to receiving Epic access. Clinicians are granted access by their departments but must show proof of training via PEAK. Non-clinicians, e.g., PhD researchers, research coordinators, etc., may have read-only access to Epic, please discuss this with your Department Administrator.
Visit the Epic-Learn Center in PEAK for information regarding the training requirements based on your role. Requests for Epic access must be granted by your Department Administrator via Sailpoint prior to taking PEAK training. Access to Epic will be provided approximately 5 days after completing PEAK training.
Conducting Cohort Queries in Epic
Slicer Dicer is an Epic-based self-service cohort query tool that allows users to have quick views into patient populations. Slicer Dicer data are pulled from the Epic electronic health record system’s (EHR) backend data warehouse (Caboodle). Data in Slicer Dicer are current through the prior day.
Slicer Dicer features include:
- Self-service query tool
- Query Epic data warehouse (Cadoodle)
- Conduct de-identified queries (basic access)
- Conduct identified queries upon IRB approval (drill down access)
- Easy querying – for example, when filtering for “diagnosis”, can select to include diagnosis from provider visits, admission diagnoses, discharge diagnoses, and ED clinical impression, or all of the above
- Export graphs and results
- Typical Query
- Investigating trends over patient populations
Mount Sinai Hospital (MS) and Mount Sinai Queens (MSQ) – inpatient data are available from 2011 to date.
Mount Sinai St. Luke’s (MSSL) and Mount Sinai West (MSW) – inpatient data are from March 2018 to date.
Ambulatory locations – data are available from the time of implementation of Epic at each location to present.
Slicer Dicer is available to all providers at Mount Sinai via their access to the Epic EHR.
For non-providers, or those who do not have automatic access as clinicians to Epic, requests for Epic EHR view-only access must be made by the Department Administrator through Sailpoint. Within approximately one day of completing the Sailpoint request, an email will be sent with instructions on how to access the Clinical View Only Online Training in PEAK. View-only access to Epic will be granted within approximately 5 days of completing training.
Access: Slicer Dicer is available within Epic by searching “slicer” in the Epic EHR search box.
IRB Approval: IRB project approval is not needed for basic access (de-identified information). For drill-down access (identifiable information) IRB approval must be submitted to the EPIC Applications Team through the IT Help Desk.
The following Slicer Dicer training modules are available:
- EPIC – Self-service tutorial is available when you launch Slicer Dicer within Epic
- PEAK – Slicer-Dicer eLearning Modules
- Select “Epic Home”
- Select “Additional Training”
- Select “Slicer Dicer”
Contact the IT Help Desk or (212) 241-HELP.
Clinical Trial Research Studies in Epic
Registering a New Clinical Trial Research Study
All interventional clinical trials (e.g., trials involving drugs or devices) are required to be registered in Epic.
Please contact the Applications Team as early as possible in your research and grant application planning process. The actual technical set up of this function generally takes about one business day, but advance notice is required to ensure that you meet study deadlines.
Requests should be submitted through the Mount Sinai Self Service Portal. You will be asked to provide the GCO#, IRB#, and NCT# on the request form.
Instructions for submitting a request:
- Login to the Self Service Portal
- Select Make a Request
- Select Applications from the Category Browser
- Select Clinical from the Subcategories
- Select Epic Research Study Record (RSH)
- Fill out the required fields and select Order Now to complete
Linking a Patient to a Clinical Trial Research Study
When a patient signs the Informed Consent and HIPAA forms for an interventional clinical trial, the patient must be linked to the research study in Epic.
The patient will have a Medical Record Number (MRN) in Epic that can be linked to a trial as soon as he or she is registered in the system as a new patient. A patient record with the MRN is created as soon as a patient requests an MSHS appointment for the first time at a MSHS location that uses the Epic EHR system.
The clinical research study coordinator should update the patient’s research study status in Epic to reflect an Active research status. In Epic, the Active research study statuses are Enrolled, or Identified, or Interested, or Consent Signed.
For detailed instructions, refer to the following documents:
Scanning Informed Consent Forms (ICF) for Clinical Trials
It is the policy of the Mount Sinai Health System (MSHS) that the signed informed consent forms (ICFs) of patients enrolled in an intervention clinical trial are scanned into Epic. Exceptions are HIV or Psychiatry research studies.
Note, Principal Investigators are required to maintain the original signed ICF in the research binder.
Questions - Contact Research Compliance at (646) 605-7120.
Linking a Patient Encounter to a Clinical Trial
To ensure appropriate billing, all research visits or encounters that are associated with an interventional research protocol are required to be linked to the research study.
Setting up Research Orders for Clinical Trials
Research clinical services (labs, diagnostic tests, etc.) as well as investigational drugs or biologics from Investigational Drug Services (IDS) must be ordered in Epic.
Investigational Drug Service (IDS) Orders - IDS must be notified as soon as a GCO# is established in order to initiate the process of creating a medication record in Epic. Ordering of all research medications can be done by searching by the "GCO#". Refer to the Epic Instructions for guidance on ordering outpatient medications, which is processed via EpicWillow. All outpatient prescriptions must be communicated to IDS at least 24 hours in advance.
Oncology Studies - For oncology studies that utilize Epic Beacon, IDS must be notified when there is a patient in screenings so the Beacon Treatment Plan can be built.
If you are utilizing the BioMedical Engineering and Imaging Institute (BMEII) for imaging, orders and scheduling must be conducted through Calpendo. For more information, refer to SOP 103, the SOP for Scheduling a Research Study.
Questions – Contact Christopher.Cannistraci@mssm.edu
Requesting Clinical Trial Monitor/Auditor Access
Requests for temporary research monitor/auditor access to Epic, including remote access can be made to Health Information Management (HIM).
The requester will need to submit a request to HIM at least one week prior to the scheduled date of review.
For step-by-step instructions the research team can refer to the internal document Research Team Guidance: How to Request EPIC Access for Remote Monitoring. This includes contact details for HIM and an example email request template.
The Research SOP 001 can be provided to the monitor for instructions for set-up requirements, as well as the ROI Inspector Workflow guidance. The updated HIM Policy 19.3 Providing EPIC Access to Outside Reviewers can be provided to the sponsor or sponsor representative, if requested.
Note to access these documents in SharePoint, you may be prompted to enter your MSHS credentials.
Unlinking Patients from Clinical Trials and Closing Out or Terminating Clinical Trials
Because all interventional clinical trials (e.g., trials involving drugs or devices) are required to be registered in Epic by research teams (PI or designee), clinical trials also must be closed out in Epic when they end.
In addition, a research team’s clinical research coordinator is responsible for updating a patient’s study status in Epic when that participation status changes, including when the clinical trial has ended.
A study team’s clinical research coordinator must go into Epic and update a patient’s study status to the appropriate status from among the following, Declined, or Completed, or Disqualified, or Withdrawn, or Off-Study, as soon as possible after a patient withdraws or completes a study, and after a study ends.
To close out a clinical trial in Epic, you need to request that the Epic Applications Team do so. The Epic Application Team’s technical work generally takes about one business day. The study team should submit their request to Epic Applications team via the IT Help Desk at least week prior to the close of the study, to allow enough time for the MSHS Epic team to schedule and complete this work as soon as the study closes.
For directions on how to update a patient’s study status in Epic for a clinical trial because the patient has withdrawn from a study, completed it, or because the clinical trial has ended, please see this tipsheet for “Linking a Patient to a Study".
To close out a clinical trial altogether, call email ITHELPDESK@mountsinai.org and provide them with the following information:
Short Study Name (to uniquely identify protocol): __________________
Brief Description (Intervention, etc.): __________________
And at least one of the following:
Study Code (GCO#): __________________
NTC #: __________________
IRB Approval #: __________________
Clinical Research Billing Issues
Internal email for getting help with billing issues.
Central Billing Office
Recruitment for Clinical Trial Research
Clinical Trial Recruitment Alerts (CTAs)
This is an Epic-based tool that is set up to notify clinicians with an alert when patients match research criteria for a particular research study. A patient can match clinical data related to age, diagnosis, and lab results, for example.
Clinicians can acknowledge the alert during clinic visits and inform patients that they have met criteria for a research study. This clinical decision tool is helpful for research teams to identify potential patients that wish to be contacted about participating in research. When the alert is acknowledged by a clinician, a secure message can be sent to the research team for review.
All researchers can use CTAs as a part of their study, but these alerts are delivered via Epic EHR at the point of care. The situation for which CTAs are most appropriate is when patients are seen by a provider that is part of the inclusion group that will see the alert soon after alert is created.
Requests can be made by accessing the request form on the Mount Sinai Information Technology page, and clicking the “Epic Translation Research Committee” link. The completed Epic Recruitment Feasibility Form should be emailed to the IT Help Desk.
The Epic Applications Team will respond via email in approximately 48 hours after receiving the request from the IT support desk. A meeting/call will be scheduled to discuss the project with the study team and a clinical informatics representative at the earliest convenience for all, generally within two weeks. Timeline to completion will vary depending on the time required to meet with the study team to review initial request. Generally, Clinical Trial Alerts are implemented approximately 3-4 weeks from the time of the approval meeting.
IRB approval will be required for clinical trial recruitment alerts.
CTA Submission Template Language
This study will use Epic Clinical Trial Alerts (CTAs) to accrue patients for clinical trials. Alerts will be presented to providers at the point of care in the EpicCare EHR (Electronic Health Record) for patients matching screening criteria for a clinical trial. Before accepting requests for CTAs, all trials are assessed for feasibility as well as the potential for alert fatigue. At the point of care the provider will see an alert informing him/her that this patient might be a candidate for <title of study>. The provider can then discuss with the patient and choose, “yes, interested” in which case an inbox message is sent in Epic to the designated research personnel. The patient will then be contacted to discuss the trial further and obtain consent. If the patient says “no,” a message via Epic inbox will also be sent to the designated research personnel.
Our trial will reconcile all messages received as a result of CTAs with other means of accruement such as reports and phone calls. This will ensure that no patient is asked twice. We will supply the Epic team with an end date for our study.
Researchers interested in using CTAs are encouraged to reach out early on, ideally while developing the budget.
The Epic Application Team build fees are $160/hour. The cost of an alert typically runs about $1000, depending on the complexity of the study.
Contact the IT Help Desk.
Clinical Research Tools in Epic
Epic Data Requests (Epic Data Reports)
Epic data is available for cohorts of interest for Quality Improvement and research projects. Epic data is only available from the time that the Epic system went live at each hospital and practice, which at the earliest is 2006 for ambulatory practices surrounding the Mount Sinai Hospital (MSH), and 2011 for inpatients at MSH.
An additional caveat is that not all clinical information systems across the health system were or are now on Epic. An example is Provation, which is the clinical system used for anesthesia documentation. Provation is not an Epic system module. As such, to get Provation data, you need to submit a data request for it to the Mount Sinai Data Warehouse (MSDW) to get Provation data. In general, the MSDW is the primary source for most longitudinal data requests because it contains data sets not available in Epic.
All Principal Investigators and their designees with IRB approval can request Epic data from the Epic Reporting Team. Quality Improvement requests may be made as well.
Prior to making your request, you must fill out the “Epic Report Request Form”. Note, this from is on the IT Dept Intranet and must be accessed on campus not through VPN.
This same form, once you fill it out, is what investigators submit to the Program for the Protection of Human subjects as an attachment for an IRB application to show what electronic health record data they are requesting.
When you submit this completed form to request Epic data for research requests, you must also submit your IRB approval form. When you submit this form for Epic data for Quality Improvement purposes, you must also submit a signed approval letter from your Departmental or Division Chair/Chief. If your department has a Quality Improvement Board, the signed letter of approval may come from your unit’s Quality Improvement Board.
This Epic Data Request form is then submitted via email to the IT Help Desk to which you would also attach your IRB approval form or QI approval letter. The IT Help Desk can be reached at (212) 241-HELP.
Researchers are encouraged to submit their requests to the Epic Reporting Team as soon as possible before they wish to have data. Given the volume of requests, it can take about 8-10 weeks from the time of request for the team to fulfill your request.
The assigned analyst will contact you with any questions during this time. The analyst will send you a sample data set for final validation. Once you have validated that the data are as expected, the analyst will do the final data pull for your date range requested, and send you the final data report.
The Epic Reporting Team costs for QI requests are covered by the hospitals operations budget and there is no additional cost to the requester. For research data requests, the cost is $165/hr.
Research Custom Workflow Design
Research Custom Workflow Design comprises the combination of Epic EHR tools used in everyday practice, but customized for the research study. This includes Epic tools such as Best Practice Alerts (BPAs), flowsheets, order sets, screening questionnaires, SmartText for customized documentation in notes, customized patient education verbiage and patient-facing questionnaires within MyMountSinaiChart, with connectivity to records in Epic.
Research Custom Workflow Designs are created to facilitate clinical research and support clinical and patient workflows within the research design. An example is the design of a MyMount SinaiChart questionnaire which can be associated with unique primary care appointments. The questionnaire can be published to a patient’s MyMountSinaiChart account when the unique appointment is scheduled, and the patient will be alerted when the questionnaire becomes available in MyMountSinaiChart. A number of clinic tools can be developed to support patient responses to the questionnaires, including provider alerts via BPA, and SmartText guidance to providers.
Note: It is possible that a custom build could be incorporated into certain clinical trials although that is generally not the case. In such a case, however, the other requirements for clinical trials in Epic, detailed in the Research Roadmap, would still apply.
All Principal Investigators with IRB approval can request a Research Custom Workflow Design build.
Requests can be made by contacting the Epic Application Team through the IT Help Desk, (212) 241-HELP.
Researchers are encouraged to reach out to the Epic Applications Team early in the planning process, prior to grant submission.
The Epic Application Team build fees are $160/hour. When a request is made, the Epic Applications Team will provide a cost estimate based on the complexity of the build.
Patient Reported Outcomes Questionnaires – Computer Adapted Testing
PROMIS® (Patient-Reported Outcomes Measurement Information System) comprises a set of patient reported outcomes measures developed by the HealthMeasures initiative headed by Northwestern University, through funding from the National Institutes of Health.
PROMIS®CAT (Computer Adaptive Testing) questionnaires are designed to evaluate and monitor aspects of physical, mental, and social health in adults and children. Since the questions are Computer Adaptive, the answer to one question or set of questions will determine the following questions or set of questions that the participant is asked.
Compared to questionnaires with static content, the content within PROMIS®CAT questionnaires are dynamically generated based on the participant’s answers. A consortium of nine Clinical and Translational Science Award (CTSA)-holding institutions, headed by Northwestern, worked with electronic health record system (EHRs) vendors to integrate PROMIS®CATs into EHRs.
Currently available PROMIS-Cat questionnaires in Epic for providers to use. Their official titles in the system are as follows:
- PROMIS-29 V2.0 PROFILE SHORT FORM
- PROMIS CAT V1.0 – ANXIETY
- PROMIS CAT V1.0 – DEPRESSION
- PROMIS CAT V1.0 – FATIGUE
- PROMIS CAT V1.0 (NEDERLANDS-VLAAMS) – ANGST
- PROMIS CAT V1.0 (NEDERLANDS-VLAAMS) – DEPRESSIE
- PROMIS CAT V1.0 (NEDERLANDS-VLAAMS) – PROBLEMEN SLAAP
- PROMIS CAT V1.0 (NEDERLANDS-VLAAMS) – SLAAPSTOORNISSEN
- PROMIS CAT V1.0 (NEDERLANDS-VLAAMS) – VERMOEIDHEID
- PROMIS CAT V1.0 – SLEEP DISTURBANCE
- PROMIS CAT V1.0 – SLEEP-RELATED IMPAIRMENT
- PROMIS CAT V1.1 – ANGER
- PROMIS CAT V1.1 (NEDERLANDS) – BELEMMERINGEN DOOR PIJN
- PROMIS CAT V1.1 – PAIN INTERFERENCE
- PROMIS CAT V1.2 (NEDERLANDS) – LICHAMELIJK FUNCTIONEREN
- PROMIS CAT V2.0 – ABILITY TO PARTICIPATE SOCIAL ROLES & ACTIVITIES
- PROMIS CAT V2.0 – EMOTIONAL SUPPORT
- PROMIS CAT V2.0 (NEDERLANDS) – SOCIALE ISOLATIE
- PROMIS CAT V2.0 (NEDERLANDS-VLAAMS) – VERMOGEN SOC ROLLEN
- PROMIS CAT V2.0 – PHYSICAL FUNCTION
- PROMIS CAT V2.0 – SOCIAL ISOLATION
- PROMIS CAT V2.0 – UPPER EXTREMITY FUNCTION
- PROMIS PARENT PROXY CAT V1.0 – MEANING AND PURPOSE
- PROMIS PARENT PROXY CAT V1.0 – PAIN BEHAVIOR
- PROMIS PARENT PROXY CAT V1.0 – PHYSICAL ACTIVITY
- PROMIS PARENT PROXY CAT V1.0 – PHYSICAL STRESS EXPERIENCE
- PROMIS PARENT PROXY CAT V1.0 – POSITIVE AFFECT
- PROMIS PARENT PROXY CAT V1.0 – PSYCHOLOGICAL STRESS EXPERIENCE
- PROMIS PARENT PROXY CAT V2.0 – ANXIETY
- PROMIS PARENT PROXY CAT V2.0 – ASTHMA IMPACT
- PROMIS PARENT PROXY CAT V2.0 – DEPRESSIVE SYMPTOMS
- PROMIS PARENT PROXY CAT V2.0 – FATIGUE
- PROMIS PARENT PROXY CAT V2.0 – MOBILITY
- PROMIS PARENT PROXY CAT V2.0 – PAIN INTERFERENCE
- PROMIS PARENT PROXY CAT V2.0 – PEER RELATIONS
- PROMIS PARENT PROXY CAT V2.0 – UPPER EXTREMITY
- PROMIS PED CAT V1.0 – COGNITIVE FUNCTION
- PROMIS PED CAT V1.0 – LIFE SATISFACTION
- PROMIS PED CAT V1.0 – MEANING AND PURPOSE
- PROMIS PED CAT V1.0 – PAIN BEHAVIOR
- PROMIS PED CAT V1.0 – PHYSICAL ACTIVITY
- PROMIS PED CAT V1.0 – PHYSICAL STRESS EXPERIENCES
- PROMIS PED CAT V1.0-POSITIVE AFFECT
- PROMIS PED CAT V1.0 – PSYCHOLOGICAL STRESS EXPERIENCE
- PROMIS PED CAT V2.0 – ASTHMA IMPACT
- PROMIS PED CAT V2.0 – DEPRESSIVE SYMPTOMS
- PROMIS PED CAT V2.0 – FATIGUE
- PROMIS PED CAT V2.0 – MOBILITY
- PROMIS PED CAT V2.0 – PAIN INTERFERENCE
- PROMIS SCALE V1.2 – GLOBAL HEALTH
These questionnaires can be sent, by an Epic clinical user, to a patient’s MyMountSinaiChart (MyChart) account. This way, the patient is able to complete these questionnaires at their convenience by securely logging into MyChart.
The content within these questionnaires comes directly from the PROMIS® system. At this time, Mount Sinai does not have the ability to make any changes to the content within the PROMIS® CAT questionnaires that are in the MSHS Epic system.
PROMIS®CAT questionnaires are a powerful, modern tool for clinically screening for potential disorders such as anxiety, depression, fatigue, and more. The questionnaires can be used for clinical patient-care and clinical research purposes.
Most Epic clinicians and support staff already possess the needed Epic security to send PROMIS-CATs questionnaires to a patient’s MyChart account. Residents/fellows, however, are not able to send questionnaires. Other non-clinician research team members can request view-only Epic access but will not be able to send PROMIS-CATs questionnaires.
Instructions on how to send a PROMIS-CAT questionnaire to a patient’s MyChart account:
- Log into Epic Hyperspace and click the inbasket icon.
- Click “PATIENT MSG” and select your patient.
- Compose the subject and body of your patient message and click “ADD QUESTIONNAIRE.”
- Type in PROMIS in the search bar and click the magnifying glass icon to search.
- Select one of the available PROMIS questionnaires and click the “ACCEPT” button. Above is a list of all currently available PROMIS-CAT questionnaires.
- Click the “ACCEPT AND SEND” button to send the message with the attached PROMIS questionnaire to the patient’s MyChart account.
- Once the patient completes the questionnaire, it will be available in both your Epic Hyperspace inbasket, as well as chart review.
- Additional information for clinicians & researchers:
- When clinicians review PROMIS-CATs, they need to note the review in their documentation, because the review of patient-reported outcome information can increase complexity of an encounter and impact billing.
- We suggest that clinicians create Smart Phrases to indicate “I reviewed the patient-reported outcome questionnaire for X” and they can tailor the X for whichever questionnaire they have sent and reviewed.
- If researchers want to use PROMIS-CATs for research purposes, they must indicate this in their IRB-submitted research protocol, and it must be IRB-approved beforehand.
- Once your patient has submitted the questionnaire, you will receive an inbasket message in the patient questionnaires folder containing your patient’s responses.
- Alternatively, you can open chart review in Epic Hyperspace, select your patient’s MRN, and the questionnaire submissions will be included in a MyChart message encounter.
- If you would like to place the results into a note, you can locate the questionnaire submission using either of the methods indicated above (# 9, 10), and you can copy and paste the questionnaire answers into a note by right clicking and selecting copy, and then right clicking and pasting into a note.
If you need additional assistance please contact the Epic Applications Team through the IT Help Desk, (212) 241-HELP. Please ask the help desk associate to assign the ticket to the MyChart team.
When you make your request, you will need to indicate whether you are requesting a PROMIS CAT for clinical patient care or for clinical research purposes. If you making a request for clinical research purposes, you will need to include your IRB approval with your request.
The Epic Applications Team will contact you by phone or email within two business days of receiving your ticket.
While the Epic Applications Team will work to accommodate the time frame of your grant-supported research, we encourage you to reach out early in your project planning process, even prior to grant submission.
There is no cost for the basic use of these PROMIS®CAT questionnaires.
If a research team wants to incorporate PROMIS®CAT questionnaires into a Custom Research Workflow in Epic, the cost for that is $165/hr. Please see Custom Research Workflow in Epic for more information.