May 2022
Developed by the NIH EHR Working Group
Patient Status Flag Workflow
Introduction and Purpose:
Patients of Healthcare Provider Organizations (HPO) that have joined the All of Us Research Program (AoURP) may consent to share an Electronic Health Record (EHR) with the Program. So far, HPOs are responsible for verifying patient’s identity at the PM&B visit, then later, transferring their EHR records to the DRC. The program has been tracking EHR transfer rates by quantifying number of records transferred out of total AoU participants enrolled at the HPO.
However, HPOs may also enroll participants who are not their patients and will not have any EHR records to transfer to the Data Research Center (DRC). This has resulted in data transfer rates (A & B) that are negatively skewed, as non-patients are not excluded from the denominator.
In 2019, HealthPro placed a Patient Status Flag (PSF) for HPO staff to denote whether an AoU participant has a EHR with their HPO. The plan is for this information to help exclude non-patients when calculating data transfer rates, by creating a rate that only includes AoU participants whose EHR data transfer by the HPO is possible.
The DRC and program staff have now launched Data Transfer Rate C, using a denominator that excludes non-patients, to more accurately reflect the percent of EHR transferred for each HPO. Since non-patients are indicated by the PSF, a standardized process for updating the PSF field must be used in order for Data Transfer Rate C to be accurate. When sites omit utilizing the Patient Status Flag or are inconsistent in the way they select the responses (Yes, No, No Access or Unknown), the Data Transfer Rate C metric will also be inaccurate.
Therefore, it is recommended that sites adopt the process of confirming or disclaiming patient status with all participant accounts.
The following instructions will outline the conditions for how the Patient Status Flag should be used:
Process for Patient Status Flag selection:
1. During in-person PM&B, HPO staff performs ID verification and any needed data linkage and registration in their local systems per their SOP. Each site should have procedures where staff verifies the participant is who they say they are, their identity matches with their HealthPro record (PMID)and matches local study registration systems and/or EHR record. See ‘OnSite IDV SOP:
2. Then, staff will access the Patient Status Flag field in HealthPro. They will provide the participant status information by selecting ONE of the appropriate response options:
§ Yes: Confirmed in EHR system
- This is selected if an EHR record is found for the participant with matching name/DOB/ etc.
- ‘YES’ should not be selected for participants for whom an MRN or empty patient record is created solely for the purposes of participation in the AOURP.
- Participants’ EHR consent status and withdrawal status is irrelevant to this step of confirming existence of EHR records and marking YES in the PSF. It is also not the study staff’s job to review each participant’s EHR record to adjudicate whether there is any or enough data components to mark this as a Yes.
§ No: Not found in EHR system
- This is selected if staff member attempted to look for the participant’s EHR in their local system and did not find one. The participant does not exist in the HPO’s EHR system.
- However, if the HPO should later acquire the participant as patient*, and/or was able to send EHR data from a neighboring institution, the HPO should change Patient Status from ‘No’ to ‘Yes’ before submitting a Batch upload to the DRC.
- *Please note that HPO’s AoURP awards may contain stipulations that forbid the HPO from coercing, marketing to, soliciting non-patients into their HPO for medical care.
- If there is NO MRN, then Patient Status should be marked as “No: Not found in the EHR system”.
§ No Access: Unable to Check EHR System
- This should be selected if a staff member is unable to search local systems. The HPO study team will need to check the EHR systems within 30 days, or prior to the next EHR data submission (whichever is sooner) and update the PSF.
- Even if the participant indicated that their EHR is at a different HPO location, click No Access because the staff member at the enrolling HPO does not have access to their own EHR system to check the existence of participant as a patient.
§ Unknown: Inconclusive search results
- This should be selected if staff member was able to review the EHR system but was not able to conclude a ‘Yes’ or ‘No’ of whether the participant has an EHR record in their HPO. For example, the staff member is unable to match demographics to assure that the EHR record matches with the participant’s identity.
- The HPO study team will need to go back to check EHR systems and utilize additional methods to verify the Patient Status Flag as ‘Yes’ or ‘No’, upload EHR before EHR data submission to the DRC.
- Unknown can also be selected if MRNs haven’t yet been recorded in REDCap or other local systems (i.e., haven’t finished on-site enrollment) or if MRNs are recorded but the identification validation process is still pending.
3. Add additional comments about patient status, if applicable.
4. Click ‘Submit’ to capture the participant’s patient status.
5. To update a previously confirmed patient status, click the ‘Update’ button, select the new
Patient Status and enter a reason for updating the status in the comments box.
NOTES:
*When a site does an EHR upload, it should be tied to the Batch updating (e.g., done quarterly -at a minimum or in parallel with EHR submission)
*If the site does not do Batch updating, then the Patient Status needs to be updated after 30 days or sooner.
*Creation of a medical record number (MRN):
Some sites have a workflow of creating a MRN for new All of Us participants who are not patients and thus do not have an EHR with the HPO
It is recommended that these sites that create an empty MRN, mark the Patient Status Flag as ’No’. Creating a MRN or an empty patient record will work against the Data Transfer Rate C, as now the denominator is increased.
It is important for sites need to work out a way to determine out whether EHR data exists for those MRNs that may be empty. If sites have not been keeping track of MRNs they created for AoU participation, then they need to have a good SOP to figure out whether EHR data exists for those MRNs that may be empty.
Sites need to work out a way to make sure Patient Status: ’YES’ has to mean there is existing EHR record that is NOT created solely for AoU participation.
*Please note that HPO’s AoURP award may contain stipulations that forbid the HPO from coercing, marketing to, soliciting non-patients into their HPO for medical care.
Reconciling ‘No Access’ or ‘Unknown’ patient statuses:
HPO site needs to reconcile statuses that were previously set as ‘No Access’ or ‘Unknown’ by providing an update on whether it is a ‘Yes’ or ‘No’. This refresh and correction should happen within the 30 days of PMB, or prior to the next EHR upload. HPO sites can do this using a method that works best for them. Some sites ask a staff to update this by hand, other sites do a batch upload.
Batch uploading of patient statuses:
Many HPO sites update the Patient Status field during in-person PMB, where staff member provides that information in HealthPro. This happens same day, or soon after the participant completed the visit. It is recommended that this update is performed within 30 days of PMB.
Other HPO Sites do not do that. Instead, they update Patient Status field via batch upload.
Again, it is recommended that batch updates to be done within 30 days of PMB, or prior to the next EHR upload. This ensures a new round of EHR submission to the DRC comes with current Patient Status Flags all participants.
DEFINITIONS
i. AoURP - All of Us Research Program
ii. PSF- Patient Status Flag
iii. HPO - Healthcare Provider Organization
iv. DRC- Data Research Center
v. MRN- Medical Record Number
vi. EHR- Electronic Health Record
vii. Data Transfer Rate C: an EHR metric that uses a denominator that excludes non-patients to more accurately reflect the percent of EHR transferred for each HPO.
Eligible Participants (EHR Consent ✓, Not Withdrawn ✓) with Patient Status = Yes, with an In-Person Visit, and EHR Data Transferred /
Eligible Participants (EHR Consent ✓, Not Withdrawn ✓) with Patient Status = Yes, with an In-Person visit
*EHR Consent and Not Withdrawn data fields are included by the DRC when calculating Data Transfer Rate C. These fields are not part of the PSF update performed by HPO team members.