Strategies for Managing Risk
In the absence of clear guidance, each of the five Project HealthDesign research teams developed their own strategies for managing what ODLs would be sent to the clinical care team and how they would be handled once they became part of the clinical care "ecosystem." In short, each team set reasonable and clear expectations on the part of both the clinical care team and the patients that addressed the "who, what, when, where and how" for the electronic information sharing involved in the study:
Who: Who on the team will receive information from the patient? To what extent will the information be shared with others? With whom will the information be shared if the information indicates a medical emergency?
What: What specific information will the patient share with the clinical care team?
When: When (how often and at what times) will a physician or other clinician receive and review the information?
Where: Where exactly will the information be collected (eg, will the information remain on the patient-controlled mobile device until it is accessed by the care team)? Under which circumstances, if any, will the information flow into the physician's electronic health record?
How: How will the information be formatted so that the care team can act on it? How will patients be educated about their rights and responsibilities?
Under each research project, it was clear what type of ODLs patients would be communicating and how, where the ODLs would be stored and displayed, and who would review the ODLs, under what circumstances and how often. Consequently, the "data flows" were not uncontrolled but instead were tightly managed. Below are examples of how two of the research projects managed their patient-generated data flows.
BreatheEasy
The BreatheEasy research team worked with asthma patients to capture ODLs and share them with their primary care physicians (and their clinical care teams) in order to make lifestyle and treatment adjustments to better manage their asthma symptoms. One of the principal investigators on this team is a family physician, so workflows typical of a busy family practice were part of the study design. Patients used smartphones to collect ODLs including peak flow rates, controller medication adherence, rescue medication use and reason for use, asthma symptoms and triggers, mood, physical activity, and smoking habits.
In this project, the ODL data from the patients' smartphones first passed through a nurse triage system, where nurses, who were guided by clinic-directed protocols, determined if patterns were normal, or if further follow-up with the patient or additional review by a physician was needed. The nurses reviewed the ODL data at least once a week using a "Clinician Dashboard," which graphically depicted patient ODL trends over time in a customizable web-based interface. Physicians then reviewed the ODL data with the patients using the "Clinician Dashboard" when alerted by the nurse or during patient encounters. For one patient, the Clinician Dashboard enabled the patient's care team to recognize the patient was using her maintenance medication to address acute episodes, and the rescue medication for maintenance. This review allowed the care team to correct this problem with the patient by using the Dashboard as a visual aid.
The BreatheEasy researchers reported that professional liability concerns were low among the project's participating physicians. They attributed this to the study's design, in which they purposefully made the data flows track traditional workflows in a primary care practice (ie, a nurse reviews a patient's ODL Dashboard and reports significant issues to the physician, just as if the nurse had a discussion with the patient over the phone).
Chronology.MD
The Chronology.MD team helped patients with Crohn's Disease create visual narratives of their conditions using ODL data, including measures of abdominal pain, energy level and medications, which they could share with their physicians to help determine the appropriate course of treatment. The team employed the use of an "ODL Prescription" to guide the types of ODLs that each patient shared with his or her physician under the project. The ODL Prescription was developed jointly by the participating patients, their physicians, and the entire clinical care team to ensure the most efficient and effective use of physicians' time.
Physicians only reviewed the ODLs identified in the ODL Prescription when patients came in for an office visit. Physicians or other clinical staff did not review the ODLs at any other time (patients used this data in between visits to help make adjustments to every day behaviors that can impact Crohn's Disease symptom management). Thus, the value for physicians of ODL collection under the Chronology.MD project was in the transformation of the raw ODL data into charts and graphs that presented visual "narratives" for the physicians and patients to jointly use in making treatment decisions.