Engaging Stakeholders
We designed the Monitor Trial using a pragmatic design that was informed by our stakeholders. Increasingly organizations like the Patient Centered Outcome Research Institute (PCORI) are encouraging the involvement of stakeholders in all aspects of research from study inception, design, implementation, analysis, and dissemination of results. Although the benefits and/or pitfalls of including stakeholders broadly has yet to be fully understood, this approach when executed effectively holds great promise for helping patients and providers make better, more informed choices about their health and healthcare. Below we describe how we have engaged our stakeholders to date and our plans for continued engagement.
The study team engaged a multitude of stakeholders during the inception of the study to ensure that issues and outcomes that mattered most to patients and heath care providers were fully considered. We engaged patients primarily via two avenues. First we attended two Patient Advisory Board (PAB) meetings to interact in real-time with patients, care givers and community members affected by diabetes. We also electronically surveyed patients from the UNC Diabetes Care Center Patient Registry, which at the time of the survey include over 2000 patients with diabetes across North Carolina. From these interactions we learned that there is a perceived direct link between SMBG and quality of life. Additionally the feedback we received confirmed our beliefs that quality of life is important to patients. Registry respondents reported that they would use SMBG more frequently if it held the potential to positively impact quality of life. During discussions with the PABs the topic of patient-provider communication arose. Insights from patients and caregivers highlighted the fact that patient-provider communication is an important issue and that avenues to improve this should be developed. It was viewed that consistently reviewing SMBG results together is an opportunity to build partnerships between patients and their health care providers. Registry respondents underlined current inconsistencies related to how SMBG values are utilized during clinic visits. Most (59%) reported that they believed it was important for medical providers to review SMBG values, but only 38% reported their health care providers always reviewed SMBG logs and provided feedback. Based upon this feedback we solidified the study team’s initial premise that for SMBG to be effective, both the patient and provider must be engaged in the process and as a result designed the study to include treatment recommendations that would be generated for each health care provider at the time of the clinic visit. These treatment recommendations are intended to serve as a guide to inspire discussion between patients and health care providers. To objectively capture this, we included a measure of patient-provider communication that is completed at baseline and end of study. We will be collecting qualitative data related to this topic at the conclusion of the study as well to provide greater insight.
Input from health care providers was also utilized during the design of this project. Early on the study team engaged the UNCPN membership during a large network-wide meeting. We discussed with the providers the varied recommendations made to patients related to SMBG monitoring in the real-world setting. Providers reported that the believed the primary question of SMBG monitoring effectiveness in T2DM to be an unsettled, high priority topic in primary care. This message was underscored by findings from the registry. Of the 62 registry respondents with T2DM not using insulin, 90% reported that they included SMBG as part of their self-care plan. Self-reported SMBG frequencies were: daily, 37.5%; several times per week, 37.5%; several times per month, 20%, and less than once per month, 5%. The other main take home point distilled from our conversations with providers related to the need for the proposed study to be “efficient” and minimally disruptive to the day-to-day clinic flow. This feedback guided the intervention development. Additional feedback during the planning phase of the MONITOR Trial was obtained by several other organizations outlined in Table
4.
Table 4
Stakeholders and the input in the study design
Diabetes Advisory Council/State Department of Health (DAC) | Consider health literacy issues of patients Policy subgroup would be useful to engage for this work | - Engaged the Center for Diabetes Translation and Research literacy core to join our team and assist with message tailoring - Tailoring algorithm that could be used in office - Brought in Diabetes Advisory Council as a policy subgroup |
UNC Patient Advisory Board | Emphasize quality of life questions (e.g, Can I feel better or improve my ADLs?) | Added quality of life to outcomes |
Greensboro Community Advisory Board | Important outcomes: Quality of life, hypoglycemia, health care service use, and patient empowerment. CMEs for providers, Query patient/provider community care | Hypoglycemia added as an outcome CME added for providers Added survey questions about patient-provider communication |
Diabetes Center Patient Database | A1C is important in addition to Quality of life | A1C designated as a primary outcome |
UNCPN Medical Directors | Testing is quite variable in real world clinical settings | Designed three-armed plan to address this reality and better respond to pragmatic patient issues. |
We continue to engage the stakeholders during the grant process with periodic phone calls where they have provided input on that best methods of patient recruitment, dissemination opportunities, patient scripts used during the baseline interview process. The overall goal of involving various stakeholder groups is to have key people with a variety of perspectives involved in planning, oversight, analysis, and dissemination. We consider this collaboration essential for not only designing and conducting research study that is responsive to the needs and practical question non-insulin treated type 2 diabetes patient’s and caregivers daily but also to disseminating our findings.
Clinical Implications
Self-monitoring of blood glucose in patients with diabetes has traditionally been considered to be a pillar of diabetes self-care. Scientific examinations of SMBG in T2DM have provided mixed results. An early epidemiological evaluation of the issue using a retrospective, longitudinal analysis showed that nonfatal micro- and macrovascular event rates along with fatal event rates were lower in individuals performing SMBG routinely as compared to those who were not [
3]. A multitude of clinical trials followed. Several showed a significant benefit from SMBG testing on improving glycemic control [
4‐
7], while others found no evidence of benefit [
16]. In fact, some studies even suggested harm from routine SMBG in patients with T2DM, specifically, higher rates of depression and increased cost without accompanying benefits [
31].
Given these mixed results, a series of meta-analyses and systematic reviews were conducted to investigate the benefit or lack thereof of SMBG on glycemic lowering in patients with T2DM [
1,
9,
11‐
14]. While meta-analyses can be a useful way to assess the clinical effectiveness of an intervention, they are limited by the quality and comparability of the clinical trials included in the analyses. Issues of sample size, duration/details of the intervention, and patient characteristics (e.g., newly diagnosed vs. longer duration of disease; baseline A1c level), varied considerably across the available studies. Given these critical differences, it is perhaps not surprising that the results of the meta-analyses have also shown conflicting results. However, the overall conclusion has been that SMBG is likely not cost effective for this population of patients [
1,
9,
12].
Perhaps most important to understanding these mixed results is the fact that the question being addressed by the studies is itself not consistent, falling generally into two camps: ‘simple’ SMBG and ‘enhanced’ SMBG. In studies testing simple SMBG, patients conducting SMBG were compared to patients who were not. In evaluations of ‘enhanced’ SMBG, intervention group patients and/or providers were given education or feedback such that they were better able to interpret SMBG results and use them in a meaningful way with regard to lifestyle changes and treatment modification. Among tests of ‘simple’ SMBG, A1c levels were reduced on average by 0.2%, an amount that was statistically significant in these studies, but of doubtful clinical significance [
12,
13]. Studies of ‘enhanced’ SMBG found A1c reductions closer to 0.5% [
7,
12,
15,
16]. As additional ‘enhanced’ intervention SMBG studies were added to the literature [
13,
14], more recent reviews and meta-analyses have drawn conclusions more in favor or testing [
4,
15]. This pattern suggests that, for SMBG to be an effective self-management tool in T2DM, the patient and the health care provider must both actively engage in performing, interpreting, and acting upon the SMBG values.
In an attempt to make SMBG more convenient and patient-centric, much effort has been place in improving the technology supporting SMBG. Like their non-technological predecessors the results from these early studies that marry technology and SMBG in an effort to make the process more convenient have been mixed, with some showing a benefit on glycemic control and others showing no benefit. With patients’ taking a more directive role in their health care, a large focus is being place on how usable these glucose-monitoring tools are in the real world. Generally speaking many of the applications need to focus on improved usability, perceived usefulness, and sustained adoption of the technologies [
6]. Web-based applications, applications with easy-to-use mechanisms, and applications without location restrictions (can be used at home) have been most useful [
7]. Furthermore, few studies have focused on the health care provider side of this issue. Allowing consistent, hassle free access to SMBG values for providers is an equally important part of the equation. In fact, studies of ‘enhanced’ SMBG, where both the patient and the provider were engaged in SMBG interpretation, found A1c reductions along the magnitude of 0.5% [
7,
12,
15,
16]. As additional ‘enhanced’ intervention SMBG studies have been added to the literature [
13,
14], more recent reviews and meta-analyses have drawn conclusions more in favor or testing [
4,
15]. This pattern suggests that, for SMBG to be an effective self-management tool in non-insulin treated T2DM, the patient and the health care provider must both actively engage in performing, interpreting, and acting upon the SMBG values.
One issue often neglected in prior work is the fact that SMBG could impact patient quality of life (QOL) both positively and or negatively. Testing itself is a burden and could act as a constant reminder of one’s less than ideal health status [
32]. On the other hand, testing may provide a sense of agency, improving a patients self of self-efficacy and hope for maximizing health and independence into the future [
32]. A recent Cochrane Review identified only a handful of studies that had examined health-related quality of life (HRQOL), well-being, or patient satisfaction [
1]. While these studies did not find clinically relevant differences in HRQOL for those who do or do not test, the review indicated future research was needed [
1]. In one study, HRQOL initially decreased, but follow-up qualitative interviews showed that patients in the testing groups experienced an increased awareness of illness [
4]. While both simple and ‘enhanced’ versions of SMBG were evaluated, the enhanced version included only training in the meaning of the results and encouragement to explore how lifestyle and dietary choices affect test values). Without more hands-on use of results (e.g., reports provided to the care provider), patients might have felt more ‘overwhelmed’ than empowered by the experience of testing. One of the key features of the MONITOR Trial is that we are focusing on HRQOL and other patient-centered aspects of SMBG and by the nature of the study design we are examining the impact of this self-care activity within the context of patient’s having actionable knowledge and improved opportunities for provider/patient collaboration.
While researchers and medical organizations debate the overall issue of the value of SMBG testing in NIT DM, patients face this choice daily and without adequate information as to its clinical or psychological outcomes. For some patients, their decision on testing will mirror that of their care provider. Yet more and more, patients play an active role in managing their own health. To some degree this is a necessary trend, because providers simply do not have sufficient time to provide intensive ongoing and comprehensive education and decision-making around diabetes self-management. Then too, even providers are looking for additional guidance on this question, including how to present options to patients and incorporate test results into care [
7]. The fact that patients are taking a greater role in their health care is generally positive, because those who do so also improve their outcomes.
In order to make informed patient choices, patients and their providers need accurate, generalizable and meaningful information about the merits or demerits of SMBG testing. Because the existing research, though relatively extensive, has not yet met this important need, more research must be done on this issue. The Consensus Report of the Diabetes Technology Society provides a list of recommendations for future research relating to SMBG. In regard to the intervention itself, they recommend that it a) is linked to a structured program designed to facilitate behavior change, b) has A1c as a primary endpoint but include patient-centered endpoints, c) include encouragement and support, preferably in the form of personalized, automated feedback to patients in real time, d) takes advantage of telemedicine opportunities, and d) incorporate best practices guidelines and standards for physicians [
4,
15]. Many of these recommendations overlap with others’ [
32]. In addition to these critical features, future research should be designed with a pragmatic eye, adhering as closely as possible to the real world setting in which SMBG would be carried out by patients and utilized by patients and health care providers collaboratively. To date, no large-scale, pragmatic RCT has evaluated the impact of SMBG testing in patients with non-insulin treated T2DM in which a multi-dimensional approach to SMBG value management has occurred. This is the gap in knowledge that the MONITOR Trial will fill.
While SMBG may or not be worthwhile, effective SMBG, if it exists for non-insulin treated T2DM, appears to require that it be embedded within the context of patient education around the use and interpretation of glucose readings, provider awareness of the results of repeated testing, and collaborative use of this information at medical visits [
33]. We would also argue for providing treatment algorithms to providers that are based on standard and accepted guidelines (such as the ADA guidelines) linked to SMBG report results [
34]. This step facilitates the physician’s use of glucometer result reports and can be used by health care providers during clinic visits to better illustrate their concerns when talking to patients. Finally, we feel it is important to evaluate objectively and in a real world setting the possible additional benefits of personalized feedback for patients in the form of messages delivered via the glucometer based on patients’ current and recent SMBG patterns. By pointing out troubling patterns and rewarding results that are at goal, this aspect of the approach we are calling ‘enhanced feedback’ is akin to ‘mini consultations’ with a provider between routine clinic visits, which are generally 3–6 months apart.