1. Joy Hamerman Matsumoto

2.  St Jude Medical Cardiac Rhythm Management Division manufactures implantable cardiac devices ◦ Pacemakers ◦ Implanted defibrillators  Many newer devices are capable of remote communication between the device and a web-based data base  Clinicians perform both review of remote care data and in-clinic patient follow ups

3. 3 St. Jude Medical Cardiac Rhythm Management Division focus on devices and platforms that diagnose and treat heart disease

4.  St Jude deploys a web-based system, Merlin.net, for remote follow ups  Patient devices communicate through a transmitter in their home to the web portal  Clinicians use Merlin.net to enroll patients in remote care, to schedule remote care “appointments” and to review patient data  Clinicians log into Merlin.net on a regular basis to assess patient and device status

5. 5

6.  Management recognized that users work with multiple computer systems to perform their work  Our understanding of the workflow that defines remote care of patients was limited to our product in isolation  To better integrate our product into the overall workflow, we needed to gain an understanding of users’ tasks and system interactions as it relates to remote care

7.  Most clinicians use multiple software systems to manage their patients ◦ Scheduling programs ◦ Electronic medical records ◦ Device manufacturers web-based programs  Systems are not integrated and do not share information  The addition of these multiple systems has impacted the workflow for clinicians  What can we do to improve users’ workload and impact user satisfaction?

8.  Teams of Human Factors and Clinical Systems Engineers conducted all research  Human Factors Engineers ◦ Trained in cognitive psychology, interface design and studying human behavior ◦ Use these principles to guide design of equipment and systems ◦ Knowledgeable in structuring research and analyzing results  Clinical Systems Engineers ◦ Partners in working with our users ◦ Knowledge of clinical applications and practices ◦ Biomedical engineering background

9.  Used a contextual inquiry approach ◦ Puts the researcher in the users’ environments ◦ User-centered design method that enables collection of detailed work practices through observation and interview ◦ Used to understand how and why tasks are done  Visited 13 clinics in the U.S. and 7 clinics in Europe ◦ Total of 28 participants  Summarized data to detail tasks, time, obstacles

10.  Enrollment ◦ Enter patient information so the patient can perform remote transmissions  Scheduling ◦ Arranging each patient’s schedule for remote follow ups and in-clinic appointments  Reviewing Transmissions ◦ Patient data recorded on the device is available for review  Patient Management ◦ Follow up to ensure patients are complying, answering patient questions, reminders for appointments

11. Percentage of people interviewed who answered yes

12. Schedule next follow-up Deliver letter to mail outbox Patient Chart is completed Update EHR; Update Schedule Print patient reminder Retrieve Patient Info Receive Chart Log-in to Remote Care System Enrollment system

13. Resource page Transmissions page Edit Schedule page  Scheduling is the most frequent task in remote care  Multiple system interactions are necessary to schedule Schedule page Modify schedule Update Schedule(s) EHR Access RC site Check transmission Determine next date Access RC site Manage transmission

14.  Proliferation of electronic records and software systems have mixed results ◦ Some tasks are easier and less error prone ◦ Different user interfaces and need for multiple passwords causes frustration  Users learn multiple methods of accomplishing similar tasks (little transfer of knowledge)  Clinicians are wary of Electronic health records – lack of integration; multiple data entry points

15. EuropeU.S. More integrated electronic health records Slow adoption of electronic health records Physicians use our system with little help from SJM personnel SJM personnel often available to provide on-site assistance to support physician IVR systems are used and the translations are not optimal IVR systems are used; some messages are confusing Transmitters paired and given to patients in clinic Transmitters mailed to patients’ homes (this has recently changed)

16.  Difficult to accommodate text expansion on certain screens – technical constraints / character limitations  Support for locales in IVR format only – no written support for language  Dynamic web interface – ownership of content varies by placement of content (regulatory versus marketing)  Adequate review of content by local subject matter experts (Chinese champion reviews the Simplified Chinese GUI for correct usage)

17.  Items identified as issues in the study are prioritized for implementation ◦ Many concerns addressed in the current development plan  Positioned Human Factors team to be included earlier in development planning ◦ Identify key customer issues ◦ Design, iterate and evaluate changes to the user interface  Maintain awareness of customer workflow in a broader sense to improve the experience and reduce inefficiencies