In this report, we present the results of a randomized controlled trial of a Web-based patient PHR linked directly to the physician EMR and conducted within the general primary care setting. We found that users of the DM-specific PHR were markedly more likely to have their medical regimens changed at their next clinic visit relative to patients with DM who used the non-DM PHRs. This finding suggests that, when used, our intervention may have worked to improve the process of DM care by reducing barriers to medication change at the clinic visit.
The lack of an overall impact on DM-related risk factor levels, however, can be attributed to 2 major barriers: (1) Despite the large, multipractice population covered by the study, the power to detect differences was reduced because only a small proportion of potentially eligible patients signed up for access to the parent PG secure Web portal. (2) Patients with poor metabolic control were less likely to enroll in the Prepare for Care study. We believe these limitations hold important lessons for future efforts to broadly implement Web-based strategies for changing DM care.
Effective translation of new innovations into improved DM care remains a difficult challenge for current research efforts.28
The results of our study underscore a number of critical points for future work in this area. First, evaluating the impact of new technologies and new strategies for care requires a rigorous study design. Our use of an active control study design provided the advantage of allowing us to compare 2 groups of patients who were equally inclined to enroll in a clinical trial of Web-based PHR interventions. Thus, the comparison of primary outcomes between “active account” study arms reflects the impact of the DM PHR on clinical care among patients equally inclined to engage in online PHR clinical interactions (eliminating “confounding by participation,” a methodological shortcoming in which the true effect of a patient-oriented DM intervention is difficult to isolate from its mode of delivery).
Second, because we used our network's existing online access system and linked our intervention directly to the EMR used for all patient care within our network, all patients with DM within the 11 primary care practices could theoretically have participated in the study. Although the low rates of enrollment limit the interpretation of the “real world” effect of our intervention, our results do clearly demonstrate that many patients with DM chose not to sign up for these services when presented the opportunity to engage in online access to their PCPs. Understanding this lack of enthusiasm becomes a crucial question that must be answered if we are to fully achieve the potential benefit of online PHRs.
Third, our exploratory analysis of medication changes among PHR users revealed that patients using the DM PHR were much more likely to have significant medication changes at the next clinical visit leading to corresponding declines in risk factor levels (P
< .001). These clinically significant declines in DM-related risk factor levels provide evidence that medication initiation or dosage adjustment represents a valid intermediate measure for effective DM management and also support to the idea that DM-specific patient portals linked directly to physicians' EMRs can have an important impact on reducing clinical inertia.29,30
Our study participants were younger, less likely to belong to a racial or ethnic minority group, and less likely to live in a poor neighborhood compared with nonparticipants, evidence that the digital divide remains an important barrier to the adoption of new health information technologies. Moreover, barriers to engaging in new health informatics tools may exist even among patients with existing Internet access. A recent survey conducted within our network found that nearly 50% of patients with type 2 DM currently use the Internet.31
Given that patients had markedly higher levels of general online use than PG use (52% used the Internet vs 10% PG account registration in study practices), further research is needed to identify and overcome barriers to adoption of patient health portals beyond the physical availability of an Internet connection.
The current generation of informatics tools have had only a limited and inconsistent impact on improving DM care.32-34
The DM-specific patient portal we developed included an innovative patient interface that presented key clinical information and individualized patient decision support, grouped results, and current medications within each risk factor domain (hyperglycemia, hypertension, and hyperlipidemia), and facilitated the development of a care plan that was automatically shared with the PCP as a patient-authored note in the medical record. We believe that this organizational format created a necessary first step toward the ideal patient DM portal. Missing from this intervention, however, were methods to (1) easily upload clinical information from home (eg, blood glucose level, blood pressure, weight, and exercise activities from wireless monitors) and (2) effectively integrate these data with the clinical workflow.
There are several limitations of our study to consider. Because of the novel and potentially disruptive impact on usual care of inviting patients to provide nonvisit care plan updates to their physicians, in this initial study we sought to minimize the amount of additional work required of PCPs. Prior surveys had documented physician concerns and resistance to any interventions that increased demands on their already limited time.35
Thus, we did not undertake any formal training of patients and physicians with regard to creating and acting on the care plans, and we did not seek to significantly change the ways in which PCPs currently practiced. In addition, we did not collect patient measures such as DM knowledge, level of engagement in care, or confidence with patient-physician communication that may have provided further insight into the effect of our intervention on study participants. Moreover, given the lack of impact on key clinical outcomes, we did not undertake a formal cost analysis of the program as currently designed. Finally, our study was not designed to test the marginal effect of different components of the DM PHR (eg, medications review, decision support for blood test results, creation of a DM care plan).
In summary, we adapted an existing clinical informatics system that included a password-protected patient portal to conduct a rigorous, population-level controlled trial of a novel “first generation” DM tool designed to engage and activate primary care patients toward achieving goals of care. Our findings suggest that the close link between the PHR and the patients' physicians' EMRs may have facilitated the process of medication initiation and dosage adjustment. However, despite enrolling 11 primary care practices, our study was limited by a “ceiling effect” among participants and ultimately underpowered to show differences between study consenters in the intervention vs control study arms. Success of future Web-based patient portals will require broader patient enrollment and may also benefit from significant “redesign” of current clinical practice to more effectively engage both physicians and patients (particularly older and low-income patients) in collaborative, non–visit-based care.36