Documenting and Evaluating Transparency in Primary Care

The OpenNotes project is demonstrating and evaluating the impact of sharing encounter notes between patients and their primary care physicians (PCPs) online. The project involves 3 diverse settings-- Beth Israel Deaconess Medical Center (BIDMC) and its associated primary care practices in Boston, MA, Geisinger Health System (GHS) and its primary care practices in rural Pennsylvania, and Harborview Medical Center (HMC), a county hospital and safety net provider in Seattle, WA. With more than 100 PCPs and 20,000 patients participating, we launched a 12-month trial in the summer, 2010. The effort is supported by grants from the Robert Wood Johnson Foundation Pioneer Portfolio, the Drane Family Fund, the Koplow Family Foundation, and the Katz Family Foundation.

As the general trend toward transparency accelerates, hospitals and health care systems with electronic medical records increasingly allow patients to view laboratory results, medication lists, and other parts of the medical record. However, though patients own their medical records, they rarely have easy access to notes written about them by doctors and others. OpenNotes is a simple, but potentially disruptive intervention that aims to transform the patient-clinician relationship as it furthers both transparency and the democratization of health care. The "bottom line" evaluation of OpenNotes is straightforward: Will patients and doctors want to continue now that the study period has ended?

How OpenNotes Works

Beginning in summer 2010, patients have been invited to read the notes written by their PCPs following office visits, e-mail correspondence, and phone calls. They are able to view these notes via the secure websites (also referred to as portals) where other portions of their medical records are posted: PatientSite at BIDMC, and MyGeisinger at GHS. At HMC, OpenNotes patients were the first to view notes and other parts of their records via UW Medicine e-care, HMC's electronic portal.

PCPs who volunteered to participate signed consents for the study and reviewed their patient lists to determine whether open visit notes would cause distress for any of their patients. Few were excluded, and patients on their panels who are at least 18 years old and who are registered portal users (PatientSite at BIDMC, MyGeisinger at GHS, and UW Medicine e-care at HMC) were then automatically enrolled in the study. PCPs and patients were able to withdraw from OpenNotes at any time.

Once the PCP writes and signs a note after an encounter, the note becomes "opened," and patients receive an e-mail message announcing its availability. Shortly before the patient's next scheduled appointment, s/he receives a message to review the note in preparation for the visit.

OpenNotes patients have been able to access only those notes written by their own PCPs. They could not view notes written prior to the study, nor could they view notes written by specialist consulting doctors or others who cared for them during the study.

Although the study period ended in summer 2011, participating patients at the 3 sites continue to have access to their notes while participating institutions review the outcomes of the experiment.

Evaluating OpenNotes

The OpenNotes study uses a pre-post design and comparison groups of non-participating PCPs and patients.

As documented in a paper we published in the Annals of Internal Medicine in December, 2011, we first assessed PCPs' expectations and experiences with OpenNotes in pre-intervention surveys, focusing on:

• Attitudes toward sharing notes with patients
• Communication/relationship with patients
• Content and quality of clinic note.
• Clinical quality of care.
• Potential impact on work flow

Similarly, we are assessed patients' expectations and experiences related to OpenNotes through pre-intervention surveys, focusing on:

• Engagement in care
• Understanding and adherence to PCP's plan of care
• Adherence to medication
• Attitude toward reading notes
• Communication/relationship with PCP
• Expectations about sharing notes with others

At the end of the 12-month period, we invited participating PCPs and their patients to report on their experiences by completing post-intervention surveys with a similar focus. These surveys also sought opinions from both doctors and patients about the potential future use and evolution of this change in care. We are currently analyzing these surveys, examining them both quantitatively and also gathering qualitative data, since we provided doctors and patients with ample opportunity within the survey to offer "free text" commentary. Many took advantage of this aspect of the surveys to provide us with rich anecdotes and reports about the OpenNotes experience.

Additionally, we are examining the patterns of portal usage by both patients and PCPs during the study and comparing them, when possible, to patterns before the study. Did patients actually open their notes? How many times? Did the number of e-mail messages between PCPs and patients change? At HMC, which had no portal before OpenNotes, we are also comparing use during the first 6 months to use in the last 6 months of the project.

Finally, we plan to compare health care utilization during the OpenNotes study period to utilization in the 12 months before the start of the project. We will examine patterns of use among both OpenNotes participants and non-participants. Did the numbers of primary care visits, specialist referrals, and emergency department visits change? How might that relate to the use of OpenNotes?

Baseline Findings

In May-June of 2010, we conducted the pre-intervention survey to examine PCP and patient baseline expectations about the impact that OpenNotes might have in the areas outlined above. The survey was offered electronically at the 3 participating sites, and included PCPs and patients who were going to go on to participate in the study, as well as those PCPs (and, therefore, their patients) who chose not to participate in the OpenNotes intervention.

We published our baseline, pre-intervention findings in the Annals of Internal Medicine on December 20, 2011. They suggest that patients are overwhelmingly excited about the prospect of having access to their note and envision many tangible benefits and few potential harms. PCPs, on the other hand, were less enthusiastic and expressed a variety of opinions about potential benefits and harms for their patients and their practices. While this paper deals exclusively with expectations rather than actual experiences, it represents an important step in understanding the complicated dynamics involved with patient access to doctors' visit notes.

Next: Results...

After the 12-month OpenNotes trial period ended around September 2011, we conducted the post-intervention surveys to examine PCP and patient experiences using OpenNotes. As noted above, we are currently analyzing these and many related data and preparing to publish our results in the coming months. So please stay tuned!

Additional Research Activities and Further Areas of Inquiry

Our ultimate objective is for OpenNotes to become a national standard of care. As we work toward this goal, we are undertaking a series of related research activities designed to help us understand how OpenNotes might evolve in the future, with particular emphasis on its effect on patients, clinicians, and policy makers ranging from payers to legislators.

• We are developing techniques for OpenNotes to become an educational tool for health professionals. We are interested in exploring the potential for OpenNotes to help train clinicians to bring the patient's voice back into the medical record. OpenNotes creates an unusual opportunity for promoting professionalism and humanism, concepts medical schools and training programs typically find difficult to actualize. Additionally, OpenNotes may offer a novel opportunity for evaluating clinicians by enabling patients, students, and teachers to assess the care experience, with the medical record as the hub of the wheel.

• In the same vein, we are developing educational tools for patients and those with whom they may share their notes. How can patients, their partners, and in some cases their informal caregivers take full advantage of such notes? Can they begin to contribute to shared notes, in effect forming a contract with providers that may even evolve into a new metric for improving and evaluating quality of care?

• We are also initiating efforts to stimulate patients, clinicians, a variety of health professionals, and policy makers to consider the potential role of OpenNotes in improving health care nationally. We have papers in print, accepted for publication, and in preparation that will aim at a variety of constituencies. We have also worked hard to stimulate media interest in our project.

  This is a particularly relevant time for such efforts. In the context of evolving interest in “meaningful use” of the electronic medical record, OpenNotes may amplify this concept by providing a tool for patients and their clinicians to communicate in a more collaborative way. Such collaboration holds promise for reducing errors and improving patient safety, building trust, eliminating redundancy and waste in health care, and, above all, involving patients much more actively in their care.

• In collaboration with Consumer Reports (CR), we plan to examine the experience of a national sample of CR subscribers who agree to request their ambulatory medical records. Anecdotal evidence suggests that patients often face significant logistical, financial, and administrative barriers to accessing records readily. Together with a team of researchers from CR, we will work to produce data that suggest whether or how these and other barriers affect the accessibility of the medical record to the citizenry nationwide.

• We use film also to tell the OpenNotes story. In addition to short films documenting various stages of its evolution, we plan to create a series of films that focus on personal stories about the impact of OpenNotes on patients, their families, their caregivers, and clinicians.

• And finally, from the start we have invited both participating PCPs and patients to comment, offer anecdotes, or write stories about their experiences with OpenNotes. In addition to commentary offered in the surveys, we will also conduct in-depth interviews with a number of participants in the months after the project ends.

For further information about the study, contact the Principal Investigators, Tom Delbanco and Jan Walker, at myopennotes@bidmc.harvard.edu.