research application conversion · research application conversion s e p t e m be r 3 0 , 2 0 2 0....

Research Application Conversion

S E P T E M B E R 3 0 , 2 0 2 0

1. CONVERSION, CUTOVER, AND END USER PERSONALIZATION

2. LOGGING IN

3. UPDATING STUDY ADMINISTRATIVE RECORDS

4. PATIENT TIMELINE

5. REPORTS

6. REVIEW STUDY ENROLLMENT

Agenda

Conversion, cutover, and end user personalization

Build that will be available

• Research study field updates:

• Study type

• Adverse event term sets CTCAE 4.03 and 5.0

• ROI Special Attention

• Study level auto-notification override configuration options

• Study status

• Patient-study association status updates

• Pilot billing protocols

• Reporting Workbench reports

• Security updates

Staff Conversion Begins 10/6

Getting Started

Logging in for the first time

Before you begin the conversion steps, you’ll need to check that you have the appropriate security in Epic to do so.

Confirm you have received Froedtert Network Login Credentials (these will also double as your Epic login ID and password)

• Log in to the Froedtert network via Froedtert Access

• Log into Epic using your FH Network credentials

• Locate Research tools in Epic

• Locate your Learning Home Dashboard

Select the My Dashboards tab on your home workspace

Update Study Administrative Records

The following activities will be completed vis the Study Maintenance activity. This record has a number of fields used for the administration of the study within Epic. At times, it is not the research coordinator who is responsible for a given field. Please reference the Research Record Field Ownership aide for more information on specific fields and their respective ownership.

First: Update the Study Type – All Studies

• All active studies will need their study type updated.

Study Maintenance Activity


Study users and providers

List coordinators on the Users and Providers form in order to assign them as the research coordinator for a patient. Staff members listed here have additional study-specific access for tasks such as running reports and linking encounters to the study.

• Study coordinators

• Principal Investigators

• Other Providers (use this field for co-Is and sub-Is)


Non OnCore Studies OnCore Studies

This must be done manually as there is no

interface.

The interface will populate this field so you do not need to do

anything at this time.

Right now, there might be more staff that needed indicated in this

section. Updates to OnCore will override anything manually

entered as it is the source of truth.


Specify Study Status (non-OnCore)

• All active studies will need their study type updated.



Optional Edits/Updates

• Study Links: You have the option to specify to specify links to point to the research protocol document, a recruitment website, or another resource useful for researchers or patients.

• Adverse Events settings: If you will be documenting adverse events in Epic, you have the option of using adverse event term sets CTCAE version 4.03 and 5.0.

• ROI Special Attention default: If HIM release of information staff should contact you before releasing the patient’s record to someone other than the study monitor, you can update the ROI Special Attention field on the Report Groupers form in the study record.

• Study notification defaults: You have the ability to change who will be automatically notified for things such as study patient admissions, appointment changes, and procedure results.

• Specify study arms (non OnCore studies)


! Please work with the PI and your study team to discuss instances where you might be

impacting their workflows (notifications, AEs, study team members, etc.)

Create a Patient Timeline

Studies Going Live on 10/21/20

Separate training and communication will occur for those study teams impacted

PRO00033707 (MCW IRB)Teneobio- TNB-383B

A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B, a Bispecific antibody, in Subjects with Relapsed or Refractory Multiple Myeloma

NMDP RR 19-108 (Central IRB)CTN-1703-1801

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Pilot studies only

Personalize Encounter Linking Reports

You will personalize reports that will be used for encounter-study linking. These include reports that show: upcoming appointments, upcoming admissions, and upcoming surgeries.

• Upcoming appointments: Personalize the Upcoming Appts for Patients Associated with <REPLACE WITH YOUR STUDY> report.

• Studies with research-related admissions: Upcoming/Current Admissions for Patients Associated with <REPLACE WITH YOUR STUDY> report

• Studies with research-related surgeries: Upcoming Parent Admissions Linked to Surgical Cases for Patients Associated with <REPLACE WITH YOUR STUDY> report

Scheduling and Admission Updates

Link upcoming appointments to your study

• Run your saved report created from the Upcoming Appts for Patients Associated with <REPLACE WITH YOUR STUDY> report.

Link pending admissions

• Run your saved version of the Upcoming/Current Admissions for Patients Associated with <REPLACE WITH YOUR STUDY> report.

Link upcoming surgeries

• Run your saved version of the Upcoming Parent Admissions Linked to Surgical Cases for Patients Associated with <REPLACE WITH YOUR STUDY> report.

Scheduling and Admission Updates cont…Research Visit Types

Visit Type Status on

10/21/20

Definition

New Research Patient- NRS [113] Will remain A patient who is new to the specific study/trial for which the appointment is

being requested. This will be determined by research staff and communicated

for scheduling purposes.

Established Research Patient -

ERS [112]

Will remain A patient with an active or follow-up status on the study/ clinical trial for which

the visit is being requested. This will be determined by research staff and

communicated for scheduling purposes.

Research Visit [18] Retired N/A – Appts with this visit type will be converted prior to go live.

Communication will be sent to those impacted with further direction.

Effective 10/21/20, updates to the following visit types will take place as part of the Epic Research Application go-live. Present-day scheduling workflows will remain the same.

•For those who use ERS/NRS today, little should change. Research staff will indicate the appropriate Visit Type to be utilized.

•Any future needs/use for those visit types will be tied to specific research projects. and will be vetted as part of the operational planning done for such research projects through FH OCRICC.

Vetting of individual research occurs with the FH leadership of that department

Review Your Participant Enrollment

Generate a list of all patients associated with your study in Epic

• Run the Patients Associated with My Studies report from your dashboard.

• You can use this report to quickly generate a list of patients to review, rather than looking them up via the Research Studies activity individually, but be sure to spot-check that your patients are appearing in the report as expected before using it as a work list.

Study monitor provisioning

External study monitors can review documentation completed in Epic via EpicCare Link. If you plan to have monitors completing monitoring visits at or shortly after go-live, you can release the needed patient charts to them for review proactively

After study monitors receive access to the EpicCare Link web portal, you'll use a report to release information to them.

• Run the Patients Associated with My Studies report from your Research Reporting Home dashboard.

Before 10/21 10/21/20 and later

Pre go-live - research monitor will

continue with the current process post

go-live in which each monitor has their

own Patient/Provider group. The

releasing of records will stay as it is

today post go-live

Post go-live research monitor requests

will be built with the new

Patient/Provider group which is tied to

the study. The release of these patients

will be handled by the research

coordinators

Epic Research Module

October 2020 Cutover & Conversion

Drop-In Labs

Prior to attending this lab, you should have reviewed the online training module

These labs are to assist research staff in making necessary updates and amendments to research studies

Feel free to drop in during any of the scheduled labs

Wednesday October 7th 1200-1300

Friday October 9th 0900-1000

Monday October 12th 1500-1600




Wednesday October 21st 1200-1300

Don‘t forget to practice what you’ve learned in the Epic play environment

Drop-In Sessions

What: Virtually support sessions for research staff hosted by analysts, trainers, partners, and Epic staff. This is an opportunity to ask questions, seek assistance, and gain clarification following your training and through conversion.

https://train.mcw.edu/ResearchTraining/epic.html

Virtual support for research staff

Day Date Time







Wednesday October 21st 1200-1300

https://train.mcw.edu/ResearchTraining/epic.html

Resources

By Tuesday, October 6th, 2020

The following resources will be posted within Epic on your Learning Home Dashboard as well as Infoscope and Scout.

Item Description

Research Coordinator Conversion Guide Step-by-step instructions on pre-go-live updates to complete

Research QA ChecklistAn outline of the study-based tasks that need to be completed prior to go live

Epic/OnCore Status CrosswalkOutlines the OnCore statuses and equivalent Epic enrollment statuses along with Pre-Consent, Inactive, and Active bucket

Research Admin Field Ownership DocDelineates which fields in the Study Maintenance record are owned by Research staff, OCRICC, analysts, or other

THANK YOU

research application conversion · research application conversion s e p t e m be r 3 0 , 2 0 2 0....

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