Characteristics of Patients and Physicians
Of the 394 patients in the practice, 107 patients enrolled in the randomized trial: 54 in the intervention group and 53 in the control group (). Demographic characteristics of the enrolled patients are presented in . Because the intervention and the control groups had no significant differences, the characteristics of the enrolled patients as a whole are shown. The majority of patients were middle-aged men. Symptoms of heart failure were assessed using the Kansas City Cardiomyopathy Questionnaire.14
The mean score of 65 is similar to that of a reference group of patients with New York Heart Association Class II symptoms of heart failure. Previous experience using the Internet was a criterion for entry into the study, but access to a home computer was not. Although we attempted to encourage patients without a home computer to participate, nearly all of the patients had a home computer.
Demographics of Patients at Baseline
The providers consisted of eight physicians. While all of these physicians gave consent for their clinical notes to be accessible to patients in the study, one physician declined to participate in the questionnaires and interviews.
Use of SPPARO
presents a histogram of the use of SPPARO over the course of the study. Of the 54 patients in the intervention group, 51 remained at the beginning of the trial period (January 1, 2003). Of these, 41 (80%) used SPPARO at least once. Users accessed SPPARO with a median of eight hit-days. To see which demographic factors were associated with frequency of use, nonusers were compared with low users (one to eight hit-days) and high users (nine or more hit-days), and demographic factors were correlated with SPPARO use (). Although no correlations were statistically significant, there was a trend for higher use of SPPARO to be associated with white race, non-Hispanic race, more symptoms of heart failure, and more clinic visits.
Use of SPPARO over calendar year 2002. Figure excludes two extreme observations (one patient who had 84 hit-days and one patient who had 123 hit-days).
Demographic Factors Associated With Use of SPPARO
We also evaluated which modules of SPPARO were most popular. There were 415 patient-hit-days to clinical notes (41 patients), 371 patient-hit-days to test results (37 patients), 161 patient-hit-days to radiology reports (21 patients), and 40 patient-hit-days to the guide to heart failure (27 patients).
Quantitative Assessment of Patient and Physician Attitudes
The baseline expectations of patients and physicians are presented in . Because subjects and controls did not differ in their initial expectations, the responses of all patients are grouped together. Patients were more likely than the physicians to anticipate that access to the medical record would be patient empowering. Physicians were more likely to anticipate concerns (particularly that access to records would increase patient worry and that patients would find laboratory and x-ray reports confusing).
Baseline Expectations of Patients and Physicians
At the end of the trial period, patients responded to the same questions. No differences developed between the subject and the control groups, but the Patient Empowerment Score declined for patients as a whole (as a dichotomy, the proportion endorsing the statements fell from 89% to 74%, p = 0.01). Subjects were also asked new questions about their overall attitudes toward patient-accessible records. The majority of subjects (90%, CI 82%–95%) endorsed the concept of a patient-accessible record and remained interested in reading their records in the future (85%, CI 77%–91%). Many expressed a preference for an edited form of the record that was easier to understand (40%, CI 31%–50%) and had residual concerns about privacy and confidentiality (31%, CI 22%–40%).
Changes in physician attitudes over the course of the study are presented in . Because of the small sample size of physicians, changes were not statistically significant. However, it is notable that although initially fewer than half of the physicians anticipated that access to medical records would be patient empowering, at the conclusion of the study all physicians did. The converse was true for questions addressing potential problems with patient-accessible medical records. In all but one case, fewer physicians responded that these problems “probably would” or “definitely would” occur. In addition, at the conclusion of the study, all of the physicians endorsed the general concept of giving patients access to their medical records, and all agreed that they were in favor of giving patients direct access to their test results and clinical notes in the future.
Changes in Physician Attitudes Over the Course of the Trial
Qualitative Assessment of Patients
In interviews, the attitudes of patients toward SPPARO were overwhelmingly positive. From patients in the control group, we derived categories of potential benefits of online access: learning more about their condition, coordinating care, learning about medical decision making, reinforcing their memory regarding instructions or information from the visit, increasing their participation in their care, streamlining certain processes, and confirming normal results and the accuracy of the medical record. There were few concerns. Among patients in the intervention group who had used SPPARO and whom we interviewed, their list of uses for SPPARO was essentially identical to the list of potential benefits identified in the control group interviews. Therefore, we were able to describe their experiences using the previously identified categories.
Learning More about Their Condition
Users reported that access to their records helped them learn about heart failure in general and their own condition in particular. They were able to get insights into the heart failure disease process, and this helped them focus their efforts at self-education. They also appreciated being able to keep track of the progress of their illness and treatments by reviewing their records:
I think it helps (my understanding of my condition). Especially in the reports that discuss things that they would not bring up while we were talking… I can research it and say, “Oh, that's because of this, so I need to take care of this problem.”
Many patients felt that having access to their records improved their ability to coordinate their care. For example, one patient left town just after her blood was drawn for a coagulation test. While on vacation, she was able to use SPPARO to check her results, contact the office, and make appropriate medication adjustments. Another patient became separated from his medications while traveling. Accessing his record allowed him to confirm the doses of his medications and facilitated getting them replaced.
Patients also used SPPARO to provide copies of tests and laboratory results to their other doctors. This helped avoid duplicate tests and unnecessary phlebotomies in some cases. In others, it simply reassured the patients that they could hand the doctors an exact copy of the specialist's note, rather than have to paraphrase the specialist's instructions from memory.
Learning About Medical Decision-Making
SPPARO provided a transparency to medical decision making that multiple respondents valued. They liked being able to follow and understand the thought processes of their doctors. Users felt that understanding the process of medical care brought a number of benefits, including reassuring them, giving them a greater sense of control, allowing them to participate in their own care at a deeper level, improving their communication with their doctor, and increasing their appreciation of the doctor's skill and expertise:
Having access to their reports after the fact is really helpful and helps me understand more clearly where they are going and what they are thinking.
I think I have a much better understanding in the monthly exams of what the doctors are looking for and because of that I am more aware of what to look out for between exams. So I feel more in control and enabled to talk to what the doctors are looking for.
Most respondents reported using their records as a memory aid. Whether to confirm medication doses, changes in their regimen, or test results, many respondents commented that they had difficulty remembering all the information that was conveyed during their appointment. They liked having the record available as a reminder between appointments:
When you are with your doctor there is so much information coming at you, that there is absolutely no way that you can process all of it. And, so then you go to the notes, usually that evening or the next day. Even with my husband sitting there, there were a lot of things that we did not hear.
Increasing Participation in Medical Care
Many respondents felt that having access to their records increased their participation in their medical care:
I feel like I'm having a more active role. My health is my responsibility. And this helps me a great deal. You are giving me another tool so that I can manage my health.
Streamlining the Flow of Information
Many felt that having access to their records increased the efficiency of getting information. They did not need to leave phone messages to retrieve test results, and it was easier to get copies of records for their own use.
Confirming Normal Results and the Accuracy of the Record
Several patients mentioned that they might not hear about normal results and were left to infer that “no news is good news.” They were reassured by being able to look up their results and confirm for themselves that everything was okay. A few users also liked having the ability to review their records for accuracy or completeness and were reassured by seeing that the details were recorded accurately.
Difficulties in Understanding Clinical Notes
Three users mentioned that medical jargon was difficult to decipher. Nevertheless, among all users and controls there was a common sentiment that jargon was a surmountable obstacle. Users dealt with it through using medical dictionaries, using online references, asking friends or family members who were medical professionals, and asking their doctors or nurses for clarification:
I was able to ask questions of the medical people I have in my family, and when I didn't, I was able to go on the Internet and type in what I didn't understand, and then probably find out more than I ever wanted to know. So, with a little research I was able to understand.
Since jargon could be a problem, we asked patients if they would like clinical notes to be modified to make them more comprehensible. Many replied that they would appreciate access to a record that was either specially edited to reduce the jargon or a system that allowed them to find definitions quickly if they needed to. However, respondents were uniformly concerned that if the medical record was modified it might be watered down or “sugarcoated.” Overwhelmingly, they preferred the record to be candid and unvarnished:
I would rather have the doctors just write what they write and me work to understand it, than them writing it for me and leaving something out that I would like to know.
One respondent expressed his concern that giving patients access to their records might change physician documentation styles, reducing the value of the record:
Are they (doctors) more cautious in what they write because this is the age of lawsuits? Will they be reluctant to put something that is more controversial in writing or to transfer it to another doctor? I'd hate to see them hold back information because someone will see it. It's my life at stake and I want to know the good and the bad.
Some patients recognized their own potential for error in interpreting their records but did not feel that it detracted from their support for online access or their desire to access their records:
I realized I don't have the technical training or proficiency to truly understand the record. I can't come to conclusions that are clear cut…. You will be presented with a whole bunch of new knowledge, and I could come to a wrong conclusion. But it does open up another line of communication, and it's well worth it.
Patients voiced few concerns about accessing their medical records online. Several individuals in the control group voiced theoretical concerns about the security of their records online. Patients were particularly concerned that their records not be made available to employers or government agencies without their permission, although many discussed sharing the record with close family members.
Suggestions for Improvements
Respondents offered a number of suggestions that they thought would improve the system. One patient suggested electronic notification when anything is added to the record so that he would not waste time reviewing his records when nothing was new. Several individuals suggested some sort of aid that would help interpret laboratory and other diagnostic tests, so that they could better assess the significance of a laboratory or test finding. Other suggestions included attaching hyperlinks to define technical terms and providing some means for patients to annotate their records when they find errors.
Qualitative Assessment of Physicians
Before the trial period, physicians were mixed in their opinions about providing patients online access to their records. All predicted that the intervention would not change hard outcomes (such as mortality, cardiac events, and hospitalization), their decision making, or their relationships with their patients. Physicians identified potential benefits and concerns in four main domains: bypassing the physician as information gatekeeper, educating patients with the medical record, preventing versus creating medical errors, and documenting sensitive information.
Some physicians were concerned that by bypassing them as information gatekeepers, online access to records would distort the clinical encounter. It might create the expectation that patients should set the clinical agenda, forcing the doctor to address patients' issues with the record, distracting the doctor from more important issues. Others felt that increasing the availability of information would increase trust in the doctor–patient relationship and make it easier for patients to participate in their own care.
Physicians wondered how effective medical records would be at educating patients. Some noted that because the record is not intended for patient education, it is more likely to confuse than educate. Others felt that it would educate patients both about their condition and the process and complexity of the care they provide.
Whether patient access to records would increase or decrease errors was another concern. Some worried that patients would act on transcription errors (e.g., take the wrong dose of a medication). Others hypothesized that patients would identify and correct inaccuracies in their records and noted that physicians might be more compulsive in their record keeping, knowing that patients might be reviewing their records later.
Physicians were also concerned about how patients would respond to reading sensitive information about substance use, psychiatric illness, or judgments about body size. They worried that patients would be offended, thus, creating tension in the physician–patient relationship. Others felt that candor was always best and that the record was “not a place for secrets.”
The principal change in the providers' attitudes after the trial period was that their concerns about potential deleterious effects from giving patients access to their records were largely gone. In the interviews after the trial period, none of the participating physicians voiced any of the concerns that they mentioned in the initial interviews.
The consensus opinion was that the SPPARO project was invisible from their perspective. In practice, they were unaware of the intervention and did not feel it affected their workflow or their relationship with their patients. Four could recall an instance of recognizing that a patient had access to SPPARO, but only one could recall a specific conversation related to it. With one exception, none of the physicians felt that any of these interactions were problematic (confusing, worrisome, overly time consuming, or embarrassing) in any way; instead, they recalled them in a positive light. The single example of a negative encounter involved a patient who was concerned that documentation of his alcohol use might have been inaccurate and could have negative consequences for him later. In this case, the physician dictated an addendum that documented the patient's concerns, allowed the patient to review it, and then added the addendum to his medical record.
Four of the seven physicians did not notice any lasting change in their style of documentation. Three physicians felt that they had changed their documentation style somewhat to make it more understandable to the patients. None of them viewed that as a problem, and none felt that it cost them a significant amount of time:
… saying this stuff in a dictation is probably all of about 15 seconds, it's not like it adds even a half hour to your day. It's just a few sentences at the end of our conclusions which makes it a little more interpretable.
Of the three who changed their documentation, each felt that this was a positive outcome. One felt that it would improve the level of honesty in the medical record:
If you … know that the patients may be reading the notes, then you should be more precise. You need to dictate more complete notes, and you can't lie. When we examine some patients, we really don't examine all the systems, so when you dictate, when you state something and you know the patient will read it, that you examine how you did it.
All the providers considered patients' interest in their medical records to be understandable and reasonable. None felt that patients should be denied access or that facilitating patient access to records was intrinsically a bad idea. One physician even mentioned wishing similar online medical records were available for her child. Physicians were divided, however, on their degree of support for continuing to offer SPPARO to patients. Two offered unqualified support, citing their belief that patients were more involved in their care and benefited from more information. The others felt that ongoing support should be contingent on the demonstration of some benefit to the patients. Each questioned whether the merits of the intervention would warrant the resources spent on it. One was concerned that it might exacerbate disparities in care, noting that such systems are more likely to be used by socioeconomically advantaged patients and may lead to those patients claiming a disproportionate share of the doctors' time.
Physicians also speculated that their clinic's experience might not be generalizable. Their clinic has a high ratio of support staff to patients, a relatively small patient population, longer-than-average clinic visits, and a patient population in which noncompliant patients were excluded. They wondered if their experience would be replicated in a practice with fewer personnel resources, a higher patient volume, and a less-sophisticated patient population.
To further assess the impact of SPPARO on the clinic, we interviewed the clinic nurses and support staff in a single focus group. Each of them could recall specific questions that were generated from patients reading their medical record. None could recall any questions or interactions that were inappropriate or problematic. Although more messages were sent to the practice in the intervention group (350 total: 287 phone calls and 63 computer messages) than the control group (267 phone calls), they did not perceive an increase in their workload during the trial period.