Partnering With Families Through Shared Decision-Making to Increase Connected Pen Use: A Quality Improvement Success Story Free

The University of Tennessee Le Bonheur Pediatric Specialists diabetes and endocrinology clinic is located in Memphis, TN. We have an inpatient service and two clinic locations in the Memphis area. Our outpatient practice includes five physicians, one fellow, and three nurse practitioners. Our additional multidisciplinary staff includes eight nurses, six certified diabetes care and education specialists (CDCESs), one licensed medical social worker, two registered dietitians, one community outreach coordinator, two authorization specialists, and one child life specialist.

As a pediatric clinic, we see children from birth until ∼20 years of age. We serve ∼800 people with type 1 diabetes and 450 people with type 2 diabetes. Among those with type 1 diabetes, 54% are on public insurance, and 42% have private insurance. Thirty-seven percent of our patients with type 1 diabetes are Black. Our main office is in downtown Memphis and serves surrounding areas that include parts of Mississippi, Arkansas, and Missouri (1,2).

People with diabetes face multiple obstacles to safe and accurate insulin delivery. For many of our patients, the amount of math needed for accurate insulin dosing is poses a barrier, resulting in a need for simplified therapy regimens that can be restrictive and difficult to follow. Over the past several years, diabetes technology has rapidly expanded and can offer relief from some of the common obstacles in diabetes care; however, newer options are not always shared or offered to patients in an empowering manner.

Connected insulin pens (CIPs) were created to make insulin delivery easier and more accurate. CIPs are reusable devices that deliver insulin from a cartridge and are synchronized via Bluetooth connectivity with a smartphone app. CIPs offer bolus insulin dose calculations based on pre-entered insulin-to-carbohydrate ratios and insulin sensitivity factors that can be entered into the device by the provider. These devices also track active insulin on board and take it into account when calculating doses. CIPs also store and share dosing data (3).

The project was completed as part of the T1D Exchange Quality Improvement Collaborative (T1DX-QI), which includes 62 endocrinology clinics working together to improve type 1 diabetes care (4).

We had previously not been prescribing CIPs with any regularity and did not have a good way of identifying which patients were using one. Not discussing CIPs or using shared decision-making to determine the best technology options for each patient was a clear quality gap.

Less than 1% of our patients were using CIPs, and we were not using our shared decision-making tool with any patients until we started this quality improvement (QI) initiative.

This was an 9-month project beginning in June 2022 and ending in February 2023.

Author G.B.N. served as our project leader. She also served as our principal investigator (PI) for our participation in the T1DX-QI. She brought years of experience, innovative ideas, and a willingness to try new things to the project. The team also included a CDCES, a nurse, and a MPH student who functioned as a research assistant for this project, although she is not a regular a part of our clinic staff.

This project was supported by the T1DX-QI, which had monthly meetings with participant clinics to promote the sharing of best practices. We were able to meet with the other sites participating in this CIP initiative to discuss ideas, plan-do-study-act (PDSA) cycles, QI cycles, and insights on the CIP implementation process. We also had the opportunity to meet with representatives from the company that manufactures the CIP we used to learn about the device and ask questions.

We formed a core group of team members who would meet bimonthly to discuss our CIP project. This group included the PI, site coordinator, clinic CDCES, and project research assistant, a master of public health student. During these meetings, we updated our Smartsheet with pertinent data, reviewed PDSA cycles, and discussed any ongoing barriers. These meetings enhanced the collaborative nature of the project by keeping everyone informed and providing feedback.

We also created a process to initiate CIPs for patients in our clinic. A patient education folder was created that included a patient guide, resources, a settings card, and contact information for the local manufacturer representative. The clinic staff handed out this folder to patients whose provider prescribed a CIP and messaged the site coordinator and CDCES to notify them when patients had begun the process. We started a Microsoft Excel spreadsheet to keep track of patients who had begun the CIP process. This document included patient information, the date on which the process was started, the follow-up appointment, and the date on which data from the CIP was last received. Some of these data were then transferred to the Smartsheet so the collaborative could also track progress.

Standardized documentation of CIP use in the EMR, through routine messaging between CDCESs and providers, was adopted to help promote clear communication among staff and improve patient care.

We used a patient self-reflection handout called My Diabetes Journey (Supplementary Figure S1) in combination with a basic technology information handout (Supplementary Figure S2) at check-in to facilitate the participation of patients and their families in shared decision-making conversations. We also created a patient education folder, which we gave to patients/families at the time of CIP initiation. The materials in this folder include step-by-step instructions for CIP use, education resources, and contact information for the local CIP company representative (5).

These materials helped to establish a baseline of information for patients and reminded them of the correct vocabulary to use when discussing possible care changes with their provider. The My Diabetes Journey form provided a quick way for providers to see what patients hoped to discuss during busy diabetes clinic visits.

Introducing a way for patients to truly participate in shared decision-making allowed for increased discussion of all types of technology (e.g., CIPs, continuous glucose monitoring systems, and insulin pumps).

• Plan. We gave My Diabetes Journey forms and technology information handouts to five patients.

• Do. We did this for 1 week.

• Study. We used this process with five patients. Two of them started the CIP initiation process, and one was already using an insulin pump.

• Act. We found that using the combination of the My Diabetes Journey form and the informational handout helped to facilitate shared decision-making and to spark conversations. We then decided to continue handing out both forms for 1 month. At the end of 1 month, we determined that both forms were very helpful and this was continued through the project.

The initiative described herein was successful in its goal of increasing the percentage of eligible patients (i.e., those using multiple daily injection insulin therapy) using a CIP. It also increased the use of shared decision-making around the use of all diabetes technology in the same time period, using a specially developed “My Diabetes Journey” tool. We used the My Diabetes Journey form to facilitate shared decision-making with 270 patients and their families, which represented 30% of our population with type 1 diabetes. We found that 9% of patients showed interest in using a CIP, and 5% are now using a CIP, which is an increase from a baseline of <1%. Put another way, 55% of patients who expressed interest in CIPs are now using one. We did not study long-term outcomes such as A1C after initiation of CIPs in this study. Using tools to encourage shared decision-making allowed for improved patient engagement in the adoption of potentially useful technology.

We plan to continue to provide My Diabetes Journey forms in combination with technology information handouts to all patients. We will periodically update our technology handouts based on patient and provider feedback and changes in the diabetes technology landscape.

We learned several lessons through this project.

• Meeting frequently with our core project team was beneficial to our progress.

• Staff buy-in was key to handing out the various materials we provided for patients. Feedback also suggested that we may need to reconsider providing all of these materials at once to avoid overwhelming staff and patients with too much paperwork.

• When patients have visual information about the different types of available technology, they are more likely to bring up these options with their provider.

• Giving patients a step-by-step process for using CIPs was helpful not only for successfully initiating these devices, but also for their ongoing use thereafter.

• The use of CIPs in this pediatric setting was hindered by the fact that multiple caregivers and/or patients did not have their own phone to connect to the CIP app. This is an issue the CIP manufacturers need to address.

• The $35 copay for the device was too expensive for some families; also, in some cases, CIPs were not covered under certain commercial insurance plans, and they were never covered by public insurance. We did not have a way to provide free CIPs in these situations, which was a major limitation and reflects broader health policy issues.

The authors thank the Leona M. and Harry B. Helmsley Charitable Trust for funding the T1DX-QI. The authors also acknowledge the contributions of people with diabetes, families, diabetes care teams, and collaborators within the T1DX-QI who continually seek to improve care and outcomes for people living with diabetes.

This study was funded by an education grant from the Eli Lilly & Company Global Medical Affairs Division, Indianapolis, IN. The T1DX-QI is funded by the Leona M. and Harry B. Helmsley Charitable Trust.

No potential conflicts of interest relevant to this article were reported.

B.V.A. assisted with developing the education folder and the process for CIP initiation, attended team meetings, collected data, and wrote, reviewed, and edited the manuscript. A.T.H. created the education folder and the process for CIP initiation, established standardized documentation of CIP use, and attended team meetings. D.D. collected data, filled out the SmartSheet, attended team meetings, and contributed to discussions. G.B.N. wrote, reviewed, and edited the manuscript; attended team meetings; discussed shared decision-making tools with families; collected data; and contributed to discussions. G.B.N. is the guarantor of this work and, as such, had full access to all the data reported and takes responsibility for the integrity of the data and the accuracy of the data analysis.