PCORI funds Dissemination and Implementation projects to increase awareness and promote the use of PCORI research findings to improve healthcare practices and health outcomes. This project is proposing to conduct dissemination and implementation activities for the results of the research project: Does Daily Self-Monitoring of Blood Sugar Levels Improve Blood Sugar Control and Quality of Life for Patients with Type 2 Diabetes Who Do Not Use Insulin? -- The Monitor Trial.
1. What research finding is this project disseminating or implementing?
With funding from PCORI, we implemented the largest pragmatic trial to date of self-monitoring of blood glucose (SMBG) in primary care patients with non-insulin treated type 2 diabetes mellitus (NIT T2DM) in the US. Among 450 adults over the age of 30 with NIT T2DM drawn from 15 North Carolina primary-care practices, the MONITOR Trial examined whether SMBG impacts A1c, health-related quality of life, or key adverse events, such as hypoglycemic frequency, health care utilization, and insulin initiation. Patients were randomly assigned to three trial arms: no SMBG, once-daily SMBG, and once-daily SMBG with enhanced patient feedback, including automatic tailored messages delivered via the glucose meter. We found no clinically or statistically significant differences at 1 year in A1c between patients with NIT T2DM who performed SMBG and those who did not. Similarly, no differences were found for health-related quality of life or key adverse events. In short, this large, targeted, randomized study found no evidence that SMBG, even when enhanced with messaging, leads to improvements in key outcomes. Based on our findings, we propose to disseminate and implement a multi-component de-adoption strategy targeted at primary care practices, healthcare providers, patients, and payers.
2. Why is this research finding important?
Ours and others’ research shows that SMBG is a low-value test that should not be routine for patients with NIT T2DM. De-adoption of SMBG can minimize the associated costs, both monetary and personal, of SMBG overtreatment. De-adoption may also provide more time and resources for clinicians and patients to focus on treatments with more proven effectiveness for NIT T2DM. Successful de-adoption can positively affect end-users by helping primary care clinicians and patients make more patient-centered decisions that reflect their preferences, needs, and values.
3. What is the goal of the D&I project?
The program, titled Rethink the Strip, delivers a multi-component de-adoption strategy to primary care practices, healthcare providers, patients, and payers. The primary objective is to engage a broad group of stakeholders to implement a patient-centered approach to the de-adoption of SMBG among NIT T2DM patients (Aim 1). Using a repeated measures design, we will evaluate the effectiveness and impact of Rethink the Strip (Aim 2). Using lessons learned, we will finalize and package Rethink the Strip for nationwide dissemination (Aim 3).
4. What is the project team doing?
We will work with six external change agents to implement five intervention components at 20 sites. We selected components from existing taxonomies of implementation strategies that target the multilevel factors influencing SMBG, and have the strongest evidence base for effectiveness. The final Rethink the Strip de-adoption strategy includes three practice components delivered directly to the practices (practice facilitation, audit and feedback, practice champions) and two directed to the health system generally (educational meetings, print and electronic materials). In our two-phase roll-out, we will implement the first three components in three practices for six months (Phase 1). Following stakeholder input and discussion of Phase 1 results, we will refine the intervention and conduct the full roll-out to the remaining 17 sites for 18 months (Phase 2). We will then finalize Rethink the Strip for broad-scale distribution. The final kit of successful strategies used in his proposal is expected to include the steps used for the audit and feedback approach, practice facilitation approaches, methods for engaging stakeholders, and materials and handouts used.
5. How will the project team evaluate its D&I activities?
Our evaluation will use the RE-AIM evaluation framework, assessing adoption by primary care practices, providers, and care managers; implementation fidelity; and patient reach. The process evaluation will also indirectly assess the potential reach of Rethink the Strip through its effects on participating practices and their providers (outcomes). Formal outcome evaluation will assess the intervention’s impact on providers’ knowledge, attitude, and self-efficacy, and the prescription of test strips.
Reach: We will use counts of the number of providers and diabetes educators attending educational and practice facilitator sessions, as well as NIT T2DM patients per practice who present for visits with their health care provider.
Effectiveness: We will survey providers and diabetes educators on knowledge and attitudes about SMBG de-adoption. Test strip prescription levels will be assessed at baseline and every three months for 18 months.
Adoption: We will examine characteristics of providers who did and did not reduce test strip prescribing, practices agreeing versus declining to participate, and providers who and do not participate in educational sessions. We will also meet with BCBS care managers to assess attendance rates and discussion of de-adoption.
Implementation: Fidelity, feasibility, and acceptability of Rethink the Strip will be evaluated via attendance logs, provider surveys, and provider/patient/diabetes educator interviews and focus groups. Brief providers surveys will be administered after each educational meeting. We will also conduct semi-structured interviews with 20 NIT T2DM patients exposed to Rethink the Strip, asking about any educational materials they received or discussions they held with their doctors. We will also conduct five focus groups with providers and one focus group with diabetes educators, discussing the usefulness of the educational materials and reactions to/experiences with Rethink the Strip.
Maintenance: In addition to our maintenance-related primary outcome of test strip prescriptions at 18 months, we will include interview, survey, and focus group questions on the likelihood of maintaining de-adoption.
6. How is the project team involving patients and others in this D&I project?
The stakeholder team that was involved in the development, implementation, and evaluation of the original MONITOR Trial will also be involved in this next phase. The team includes representatives from the North Carolina Diabetes Advisory Council, UNC Family Medicine Patient Advisory Board, UNC Physicians Network, the American Diabetes Association, the National Diabetes Education Program/diabetes educator, and patient stakeholders. For this study, we are adding the North Carolina Blue Cross Blue Shield and a neighboring health system.
In accordance with the PCORI engagement rubric, we will follow the principles of reciprocal relationships, co-learning, partnerships, transparency, honesty, and trust. Our stakeholders were instrumental in formulating research questions, defining essential characteristics of study participants, comparators, and outcomes; monitoring study conduct and progress; and disseminating results. We will continue our stakeholder meetings on a quarterly basis and more often as needed. Stakeholder input will be especially key between the two Aim 1 phases and during the final compilation of Rethink the Strip materials.
7. How will this project help ensure future uptake and use of PCORI results?
Based on the costs of SMBG and its demonstrated lack of utility, plus the degree of stakeholder input and involvement in this project, we believe our Rethink the Strip strategy has high potential for sustainability. We plan to package our strategy for broad-scale dissemination. Distribution will be aided significantly by our strong stakeholder buy-in and partnerships. Our public health stakeholders have ties to health department directors and diabetes educators and have mechanisms for dissemination through these groups. Our community stakeholders have mechanisms to disseminate messages to patients, providers, and educators.
Learn more about PCORI’s Dissemination and Implementation program here.
Related PCORI-funded Research Project
A Diabetes Home Test Can Be a Waste of Time and Money
"The Upshot" Blog, New York Times, March 11, 2019
Blog post author Aaron Carroll, who moderated a 2018 PCORI Annual Meeting plenary session about balancing benefits and potential harms of different treatment options, discusses the related study's finding that routine glucose monitoring may be unnecessary for people with Type 2 diabetes who are not on insulin. Study Principal Investigator Katrina Donahue, MD, MPH, was a presenter/panelist in that session.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.