Abstract
We report findings from a follow-up survey of clinicians from the STeP study that assessed their attitudes toward and current use of the Accu-Chek® 360° View tool (Roche Diagnostics, Indianapolis, IN) approximately 2 years after the study was completed. The Accu-Chek 360° View tool enables patients to record/plot a seven-point self-monitoring of blood glucose (SMBG) profile (fasting, preprandial/2-h postprandial at each of the three meals, and bedtime) on 3 consecutive days, document meal sizes and energy levels, and comment on their SMBG experiences. Our findings showed that the majority of these physicians continue to use the tool with their patients, citing enhanced patient understanding and engagement, better discussions with patients regarding the impact of lifestyle behaviors, improved clinical outcomes, and better practice efficiencies as significant benefits of the tool.
Introduction
One of the largest of these studies was the Structured Testing Program (STeP) study, a prospective, cluster-randomized, multicenter trial that evaluated the use of structured SMBG in 483 poorly controlled, insulin-naive type 2 diabetes mellitus patients from 34 U.S. primary care practices. 5 In the study, 13 practices were randomized to an active control group, and 21 were randomized to the experimental group for structured SMBG. Patients from the experimental practices used a paper tool (the Accu-Chek® 360° View form [Roche Diagnostics, Indianapolis, IN]) that facilitates collection and interpretation of seven-point glucose profiles over 3 consecutive days. Patients completed the tool on a quarterly basis, brought the completed tools to medical visits, and discussed findings with their physicians. At 12 months, experimental patients experienced significantly greater improvement in glycemic control, depression/diabetes-related distress, 6 and patient self-efficacy in managing their diabetes. 7 Improvements in treatment intensification by experimental physicians were also seen. 1
Because the STeP study was conducted within a controlled “clinical trial” environment, it is reasonable to question whether use of structured SMBG is as beneficial and sustainable in real-world clinical settings. In an effort to answer this question, we conducted a survey of experimental clinicians from the STeP study to assess their attitudes toward and current use of the Accu-Chek 360° View form (tool) approximately 2 years after the study was completed.
Research Design and Methods
We invited all 21 of the physicians from the experimental arm of the STeP trial to complete an online questionnaire and then participate in a phone interview to gain further insights regarding their use of and attitudes toward the tool. The 16-item questionnaire was designed to obtain information about clinicians' current level of tool utilization, types of patients, and clinical situations in which they are most likely to use the tool and logistical aspects associated with integration of tool use in their practices (see Supplementary Fig. S1; Supplementary Data are available online at
In the follow-up phone interviews, physicians were asked to describe in greater depth their past and current experiences with the tool, with a focus on key challenges that they have encountered and their perceptions of the value and impact of the tool within their practices. The interviewer used a set of scripted questions in the interview to initiate discussions with respondents (see Supplementary Fig. S2). Non-scripted follow-up questions were asked gain further understanding of respondents' answers. Descriptive statistics from the online survey and summary information from the phone interviews were produced.
Results
Fifteen of the original 21 physicians who participated in the experimental arm of the STeP trial were available to participate in the online survey. Of the six physicians who did not participate, four were no longer in practice, one was semiretired (saw patients 1 day per week), and one was unable to participate because of time constraints. Thus, 15 of the 16 physicians who remain in full-time practice completed the survey (94% response rate). Ten of the online survey respondents also participated in the phone interviews (67% response rate). There were no significant demographic differences between the 15 responders and six nonresponders.
Responses to the online survey
Current usage of the tool
Thirteen (86.6%) of the responding physicians indicated that they currently use the tool in their practices with type 2 diabetes patients; nine physicians (69.2%) reported that they also use the tool with their type 1 diabetes patients. The majority of users used the tool for >50% of their type 2 patients, and over one-third reported use of the tool in >50% of their type 1 diabetes patients (Table 1). The two physicians who no longer used the tool identified lack of ready access to the tool or that it was too difficult to maintain as their major reason for discontinuing use.
Clinical situations for tool usage
Among the current users, the majority identified patients who would benefit from assistance in problem solving as the most common clinical situation for using the tool (Table 1). Most of these physicians also reported using the tool following a medication change, in newly diagnosed patients, and in patients who were new to fixed insulin or basal-bolus insulin therapy. The majority of current users also reported using the tool as an ongoing component of self-management by having their patients complete a tool every 3 or 6 months.
Patient adherence
Most current users reported that the majority of their patients are willing to complete the tool when requested to do so (Table 1). Seven current users reported that more than three-quarters of their patients completed the tool as prescribed, and an additional three of the current users reported an adherence rate of 50–74%.
Impact of tool usage
All current users stated that use of the tool allows them to make more effective medication changes (Table 1). Most current users reported that use of the tool allows them to make medication decisions more quickly; others indicated that the tool prompts them to make more frequent medication changes. Furthermore, all users reported that the tool facilitates discussion with patients regarding the impact of exercise and meals on glucose control. In addition, most current users reported that the tool enables patients to make lifestyle changes on their own. Furthermore, the majority of current users mostly or completely agreed that use of the tool enabled them to build more collaborative relationships with their patients and engage patients in their diabetes self-management. They also reported that use of the tool improved their ability to manage their type 2 diabetes patients and improved clinical outcomes.
Responses to the follow-up phone survey
Challenges to using the tool
During the phone interview the physicians discussed some of the challenges they encountered as they implemented the tool in their practices. Two physicians said that finding the time to train staff and patients to use the tool was their major challenge; currently, they have no one on staff to provide patient training so these physicians do it themselves. Three physicians said that convincing patients to perform SMBG at the frequency required by the tool was sometimes challenging. Another physician stated that having an electronic version of the tool would be helpful, explaining that the current paper version of the tool was challenging in practices that are using electronic medical records. Two physicians also stated that the cost of strips for their noninsured patients was sometimes an issue. Other challenges included inability to gain acceptance from their peers and/or difficulties in training staff to use the tool.
Benefits of the tool
Six of the 10 phone interview participants reported that increased patient understanding and compliance with their self-management regimens were the primary benefit of using the tool. Although 10 physicians reported that use of the tool positively impacted clinical outcomes in their online survey responses, three physicians also identified “better clinical outcomes” as the primary benefit of using the tool. Many physicians also reported improved efficiencies in managing patients as a significant benefit of using the tool. For example, one physician stated that the tool allowed him to educate his patients about their diabetes self-management in a much shorter period of time. Another physician explained that using the tool improved the quality of time spent consulting with patients. Two physicians indicated that the tool provided data that allowed them to more quickly assess patients' glycemic status and make more informed decisions about therapy changes.
Discussion
Results from our survey and phone interviews suggest that appropriate use of structured SMBG as a component of routine diabetes management is both beneficial and feasible in primary care practices. Although the STeP study was completed in February 2010, the majority (86.6%) of respondents reported that they continue to use the tool with their patients, citing enhanced patient understanding and engagement, better discussions with patients regarding the impact of lifestyle behaviors, improved clinical outcomes, and better practice efficiencies as significant benefits of the tool. These benefits have also been reported in several recent studies that used various structured SMBG regimens as an integral part of comprehensive treatment interventions. 2 –5,8,9
Because the STeP study was designed to assess the value of the tool in insulin-naive type 2 diabetes, it was surprising to discover that the majority of physicians we surveyed use the tool with their type 1 diabetes patients and type 2 diabetes patients who are being started on insulin or are transitioning to more intensive insulin regimens such as basal-bolus insulin therapy. This suggests that use of the tool within these patient populations may also be beneficial, although this has not been formally studied.
Although some physicians reported that finding time to train patients to perform structured SMBG and interpret their results are key challenges in their practices, this did not deter them from using the tool. It is noteworthy that although a patient training DVD was made available to the physicians as part of the STeP study, only four physicians reported using the DVD with their patients. In the follow-up phone interviews, we found that many physicians had forgotten about the availability of the DVD program. Another challenge identified by respondents was difficulty in convincing their patients to test at the frequency required to complete the tool. However, one physician explained that once patients started seeing the results of their testing, adherence to the structured SMBG regimen was no longer an issue.
One limitation of the study was the use of self-reported data, which may not accurately reflect respondents' actual attitudes and behaviors regarding use of the tool. Another limitation was the small sample size, which precluded in-depth analysis.
Clinical trials such as the STeP study provide critical information and guidance regarding the potential efficacy of a given treatment intervention; however, they seldom reflect natural clinical environments. Thus, clinicians who lack the resources that are usually provided in large clinical trials often question the feasibility and sustainability of interventions shown to be efficacious under carefully controlled study conditions. It is noteworthy that a recent observational study using the Accu-Chek 360° View tool in real-world clinical settings showed that use of the structured SMBG intervention is practical and that it is associated with improved diabetes management. 10 However, because of the short duration of the study (3 months), the sustainability of the intervention could not be assessed.
Findings from our survey suggest that structured SMBG-focused interventions are beneficial and likely sustainable in many clinical practice settings. However, additional follow-up with participants in previous trials 2,4,5,8,9 are needed to further assess the long-term impact of structured SMBG interventions on both clinical outcomes and patient/clinician behaviors.
Footnotes
Acknowledgments
This study was funded by Roche Diagnostics in Indianapolis, IN.
Author Disclosure Statement
The authors are solely responsible for the content of this article. K.F. and J.N. are employees of Roche Diagnostics. C.G.P. has received consulting fees from Roche Diagnostics.
References
Supplementary Material
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