How Do You Balance Patient Care and Research with Online Patients? Our Proposed Protocol

What would you do with the following research requests?

The CEO of the health system would like for all patients using the EHR patient portal to be asked to sign a consent form to participate in our system-wide strategic BioBank. In this strategic project, we aim to capture an “extra tube of blood” when a patient is already getting blood drawn for a lab test for clinical care. Then we would apply genetic analysis to large populations of patients to see if we can discover gene-disease linkages that may be useful to patients. May we set up this consent form and present it to patients?
A researcher would like to survey ALL patients in the health system to ask them their opinions about marijuana use, both recreational and medical. It would be about 20 questions. The researcher does NOT have an existing relationship with most patients he/she wishes to survey.
A physician specialist would like to ask all the patients in his/her own clinic about their symptoms of arthritis, to understand how he/she can improve their own clinic’s care process and maybe publish the improvements when completed.

Such are the challenges of our MHC (My Health Connection) patient portal Clinical Leadership Advisory Group. Our goal is to protect our patients, who have signed up for MHC primarily as a communication tool between patient and clinic/physician, and not allow unsolicited research requests (potentially from hundreds of researchers) or “quality improvement” surveys or projects from “email spamming” their patient portal message inbox. AND YET, we believe that a large fraction of our patients might welcome the chance to participate in a research trial and increase our medical knowledge. How to do this? We struggled and discussed for hours, and came up with the following principles, that we are gradually implementing:

White Paper: Research queries using My Health Connection (MHC)

Executive Summary: How shall we decide on permitting researchers to use MHC for recruiting and contacting patients? Until now, research recruitment has been off-limits. We propose a framework for permissible MHC use for research recruitment and a path forward.

Background:

My Health Connection is the UCHealth rebranded MyChart patient online portal to the EHR. Patients sign up for MHC with the express intent of using it to communicate with their healthcare team directly. We have had repeated complaints from patients when they hear from unexpected sources (Administrators sending messages regarding “flu shots” or other health maintenance, as required by Meaningful Use federal regulations). We have thus been very careful about protecting patient’s presumed interest in using MHC as a purely clinical communication tool.

On the other hand, Researchers at UCHealth have great interest in using MHC for research recruitment. We have not yet (Dec 2018) implemented the Research Module within Epic for recruitment and management of potential and patients currently engaged in research trials.

Our IRB (institutional review board to protect patient rights) has been an excellent partner in restricting use of EHR for research recruitment, balancing patient needs, clinic needs, researcher needs.

To date, the only exception to research use within MHC has been: the UCHealth BioBank for recruitment, processing and notification of patient’s genomic data such as pharmacogenomics and other screenings, approved by Strategic Executive Group (SEG) at UCHealth.

Additionally, the MHC clinical leadership group have previously declined a research request to broadcast a marijuana survey to all 400,000 MHC patients.

MHC clinical leadership HAS allowed broadcasts through MHC for drug or device recalls when there are patient safety concerns. It has also allowed general health broadcasts as required to meet federal Meaningful Use regulations for patient portal implementation and use (see above).

Assessment/Recommendations for MHC research framework

Large UCHealth strategic initiatives (including research) using MHC are approved by System Executives. IRB approval is also necessary. MHC clinical group also informed.
Research requests by a Principal Investigator (PI) recruiting patients within his/her own clinical practice (where there already exists a treatment relationship between that investigator and/or his/her colleagues and their cohort of patients), should meet ALL the following criteria:
1. IRB authorizes this project to use MHC for recruitment and communication
1. Recruited patients have all been seen in the clinic(s) where the principal investigator and co-investigators work, so that there is an EXISTING physician-patient relationship
1. The Principal Investigator (PI) or authorized study team members, send and receive MHC messages individually. This is not the responsibility of the MHC IT team.
1. Online MHC recruitment should mirror any paper- or phone-based IRB-approved process
1. COUNTER-EXAMPLE: System-wide targeted patients across many clinics WILL NOT BE APPROVED AT THIS TIME. An existing physician-patient relationship must already exist between recruited patient and the investigator(s)
1. There will be ongoing assessment of any complaint received
1. The MHC team will investigate a method for PI’s to update a patient’s chart in case of DECLINING FURTHER RESEARCH RECRUITMENT.
  1. If patient declines for an individual study it will be up to the PI to track that
  1. If patient declines for ANY research outreach via MHC, we anticipate creating an FYI flag called “NO MHC RESEARCH RECRUITMENT” that we can query later to prevent outreach errors
1. MHC team will and will not:
  1. WILL: require investigators to ask permission of Clinical Advisory Committee prior to start
  1. WILL: permit 1:1 MHC recruitment messaging from PI to patient when project approved
  1. WILL NOT construct research questionnaires for online transmittal
  1. WILL NOT have patients sign online consents via MHC
  1. WILL NOT help track patients in study via reports or alerts
1. Approvals thus needed:
  1. IRB
  1. MHC Clinical Advisory Committee
  1. UCHealth Marketing for allowable messages in MHC
  1. UCHealth Patient Literacy Team for 8^th grade wording or clearer
1. Monitoring
  1. PI would present MHC component of research plan to MHC Clinical Advisory
  1. PI would present 6-monthly updates during study to MHC Clinical Advisory
    1. Patient recruitment numerator/denominator
    1. Assurances about only recruiting from permitted clinics/units
    1. Refusal rates and other concerns from patients, clinicians, staff
    1. Anticipated close of research or translation into standard practice

NOT PERMITTED: Patient recruitment outside of an investigator’s clinic (eg: show me all diabetes patients; maybe 40,000 patients or please facilitate the outreach to all DM patients). Not allowed at present
FUTURE opportunities: Epic does have a Research Module that we have not yet implemented. It may be possible to integrate research recruitment that follows all IRB necessary protocols to protect patient privacy. UCHealth will partner with UCD School of Medicine leadership to consider implementing this module in the future. As our tools evolve and with patient feedback, we will discuss the tools at MHC clinical group to review and update this guideline.