key: cord-1031141-p1lo1b0r
authors: Faulds, Eileen R.; Jones, Laureen; McNett, Molly; Smetana, Keaton S.; May, Casey C.; Sumner, Lyndsey; Buschur, Elizabeth; Exline, Matthew; Ringel, Mathew D.; Dungan, Kathleen
title: Facilitators and Barriers to Nursing Implementation of Continuous Glucose Monitoring (CGM) in Critically Ill COVID-19 Patients
date: 2021-01-27
journal: Endocr Pract
DOI: 10.1016/j.eprac.2021.01.011
sha: e886a967fe2b62a6c3f84c3b4dbe391eb53f3de5
doc_id: 1031141
cord_uid: p1lo1b0r

AIMS: We (a) describe our implementation of a continuous glucose monitoring (CGM) guideline to support intravenous (IV) insulin administration and reduce point of care (POC) glucose monitoring frequency in the COVID-19 medical intensive care unit (MICU) and (b) evaluate nurses experience with implementation of CGM and hybrid POC + CGM protocol using the PARIHS framework for implementation. METHODS: A multidisciplinary team created a guideline providing criteria for establishing initial sensor-meter agreement within each individual patient followed by hybrid use of CGM and POC. POC measures were obtained hourly during initial validation, then every 6 hours. We conducted a focus group among MICU nurses to evaluate initial implementation efforts using the PARIHS framework with content areas focused on initial assessment of evidence, context, and facilitation to identify barriers and facilitators. The focus group was analyzed using a qualitative descriptive approach. RESULTS: The protocol was integrated through a rapid cycle review process and ultimately disseminated nationally. The Diabetes Consult Service performed device set up and nurses received just-in-time training. The majority of barriers centered on contextual factors, including limitations of the physical environment, complex device set-up, hospital firewalls, need for training, and CGM documentation. Nurses perceived device accuracy and utility were exceptionally high. Solutions were devised to maximize facilitation and sustainability for nurses while maintaining patient safety. CONCLUSION: Outpatient CGM systems can be implemented in the MICU using a hybrid protocol implementation science approach. These efforts hold tremendous potential to reduce healthcare worker exposure while maintaining glucose control during the COVID-19 pandemic.

Background COVID-19 has proven particularly devastating for individuals with chronic illness, including diabetes. 1,2 Individuals with diabetes have higher rates of severe COVID-19 2 , account for a large percentage of hospital admissions [1] [2] [3] [4] and have higher mortality compared to the general population. 1, 5 Early data suggests that among hospitalized COVID-19 patients, poor glycemic control may be associated with higher mortality. 6, 7 For patients in intensive care units (ICU), guidelines recommend intravenous (IV) insulin with goal blood glucose (BG) 100-180 mg/dl. [8] [9] [10] Health care workers (HCWs) caring for COVID-19 patients on IV insulin assume increased risk and utilization of personal protective equipment (PPE) due to the need for hourly point-of-care (POC) BG testing. 11 As a result, institutions have taken unprecedented measures to reduce exposure, including bundling medication administration times and positioning IV infusion pumps outside of COVID-19 patient rooms. Therefore, the ability to safely perform remote glucose monitoring would greatly support these efforts.

Continuous glucose monitoring (CGM), is a safe and effective alternative for BG testing in the outpatient setting and has potential to reduce the frequency of POC BG testing in the ICU. 12 On April 1, 2020, the FDA notified manufacturers that it "will not object to the provision of CGM systems for the treatment of patients in hospital settings to support COVID-19 healthcare-related efforts." 13 Current evidence supports the overall safety of CGM, with similar glucose control as the standard of care in hospitals. 14- 19 However, many studies are small, focus on accuracy as opposed to efficacy, safety or implementation, and utilize older technology. 14- 18, 20 There is concern that changes in tissue perfusion, edema, hydration, acid-base balance, sensor compression due to patient positioning and medication interference may affect CGM performance. 21 Newer generation devices demonstrate improved accuracy, provide factory J o u r n a l P r e -p r o o f calibration, and have minimized interference from acetaminophen, all key elements required for inpatient utilization. 22 Moreover, the use of more frequent glucose measurement (e.g. every 5 minutes), 23 setting higher threshold alerts, 24 and predictive alerts 25 may compensate for total error and improve safety.

However,, the implementation of these devices in the inpatient setting presents unique challenges. The purpose of this manuscript is twofold, (a) describe our experience implementing a CGM guideline to support IV insulin administration and reduce the need for fingerstick point of care (POC) glucose monitoring in ICU patients with COVID-19 and (b) evaluate nurses experience with implementation of CGM and hybrid POC + CGM protocol using the Promoting Action on Research in Health Services (PARIHS) framework for implementation. Multi-site analysis of outcomes data is underway and will be reported separately.

We assembled a multidisciplinary team of stakeholders that included representatives from endocrinology, critical care medicine, nursing, and critical care pharmacy to draft an ICU protocol. CGM was piloted within a single MICU at the institution that was already positioning IV insulin pumps outside the room, enabling the greatest potential for reduced HCW exposure and conservation of PPE. We obtained approvals from the institution's multidisciplinary COVID-19 Clinical Care Workgroup.

J o u r n a l P r e -p r o o f Implementation team members participated in a 1-hour manufacturer training session focused on overall device implementation. Two educational documents, one focused on sensor insertion and initiation and the other focused on implementation of the protocol, were crafted and stored at the bedside. Content used in these handouts can be found on the manufactures website (https://dexcom.com/guides). Endocrinology team members provided a single session of one-onone training with MICU nursing leaders. This small group was tasked with device insertion, transmitter pairing and just-in-time training to the bedside MICU nurse focused on CGM validation and use.

Hybrid CGM plus POC glucose monitoring procedures and implementation appear in Figure 1 . Android phone set-up required entry of individual Dexcom Clarity account information on each phone. Alert thresholds were programed into both the Android phones and receivers and set at 100 mg/dl (lower threshold) and 300 mg/dl (upper threshold). The Urgent Low Soon predictive alert was also activated, triggering an alarm when the glucose is predicted to drop below 55 mg/dl in the next 20 minutes. Device set-up ranged from 15-17 minutes per CGM. Patient identification. MICU nursing leadership identified appropriate patients during daily rounds with MICU intensivist teams. In most cases, CGM was implemented ahead of IV insulin in order to account for sensor initiation time and establish sensor-POC agreement, thereby minimizing hourly POC testing while on IV insulin. J o u r n a l P r e -p r o o f Insertion and pairing. The transmitter and sensor serial numbers were scanned into the Dexcom app prior to entering the room for device insertion. Android phones and receivers were both kept just outside the patient room, typically 10-15 feet from the transmitter and separated by a glass paneled door. The sensor was placed on the patient's upper lateral arm (due to frequent prone positioning) using a single push inserter. 26 The transmitter was paired with the Android phone Dexcom app and receiver. Pairing typically occurred in less than 1 minute. Rarely, a transmitter required several attempts to pair. After pairing, a 2-hour warm up period began in which no CGM data were available. The sensor was worn for up to 10 days. At the time of this publication all CGM systems initiated were successfully validated; however, time to validation analysis is underway. Each patient could receive up to two sensors and would be able to keep the transmitter at discharge (which may be re-used for up to 90 days).

Nurse driven protocol. Initial sensor validation occurred using hourly paired sensor-meter readings ( Figure 1 ). The comparison standard (POC meter-StatStrip, Nova Biomedical ® , arterial blood gas) were otherwise FDA approved for use in each patient. The standard was compared to the CGM value obtained within 5 minutes. The threshold criterion for nonadjunctive use was defined as two consecutive sensor-meter pairs approximately 1-hour apart meeting either of the following criteria (Table 1) :

• CGM <20% difference from the reference when the glucose is >100 mg/dl • CGM <20 mg/dl difference from the reference when the glucose is <100 mg/dl

The IV insulin infusion was titrated every hour using the POC BG value until the initial validation threshold was achieved. Then titration was performed using the CGM with POC BG validation occurring every 6 hours. The organization's standard guideline was used for IV insulin titration and no modifications were made to incorporate CGM trend data into titration guidelines.

Additional POC BG values were obtained according to criteria in Table 1 . POC BG monitoring reverted to hourly if any of the sensor meter pairs were discordant. In order to distinguish CGM values from POC, nurses used a "CGM" annotation ( Figure 2 ).

A Clarity Healthcare Professional account was created to visualize data, but retrieval is delayed by 3 hours and therefore only utilized by the Diabetes Consult Service.

Post-infusion management. When patients were transitioned off IV insulin POC testing was continued every 6 hours. Once transferred out of the MICU, CGM could be used nonadjunctively (to replace POC testing) according to the institution's global Hyperglycemia in COVID-19 Patients guideline ( Figure 1 ).

Service, which, in concert with the intensivist team, determined when to transition patients off IV insulin ( Figure 1 ).

We conducted a focus group qualitative evaluation among MICU nurses to evaluate initial implementation efforts using an implementation science approach with the PARIHS framework. 27 The Ohio State University's IRB approved the focus group protocol. A single session focus group was conducted with nurse leaders (e.g., nurse managers, Clinical Nurse Scientists (CNS)), MICU staff nurses, and Diabetes Consult Service NPs. Interviews were analyzed using a qualitative descriptive approach. 28, 29 Participants. Eligibility criteria included MICU floor nurse who cared for COVID-19 patients on CGM; MICU nurse leader (i.e. CNS, nurse manager) who assisted with patient identification, J o u r n a l P r e -p r o o f CGM insertion, or hybrid protocol staff education; or Diabetes Consult NP who managed consult patients on CGM between June 1, 2020 and August 31, 2020. Nurses provided consent prior to focus group participation.

A single session focus group was conducted virtually. A semi-structured interview guide focused on core components of the PARIHS framework: evidence, context, and facilitation. As such, questions included content regarding perceived accuracy, protocol and CGM training, workflow, and facilitators and barriers to future use. The focus group was audio recorded, professionally transcribed, and reviewed for accuracy.

A code book was developed a priori based on the semi-structured interview questions. Interview data, fieldnotes and memos were imported into NVivo 12.0 (Doncaster, Australia) for data management and analyzed using a qualitative descriptive approach. 28, 29 Two authors (ERF and MM) conducted qualitative analysis. Portions of text were coded with terms that were low inference ("data close"); then grouped into thematic categories and subthemes. 28 The data were assessed using the PARIHS framework for implementation, a theoretical framework that has been widely used to implement to evidence-based clinical practices in the inpatient setting. 27

A total of 9 nurses participated in the focus group and included 3 nurse leaders (e.g., 2 nurse managers, 1 CNS), 2 Diabetes Consult NPs, and 4 MICU staff nurses. Participants were 89% female, ranged in age from 28-50 years, and had mean 11.6 years of nursing experience (range 3-28 years). The MICU nurse leaders and staff nurses (total n=7) had a mean of 9 years of MICU nursing experience (range 1-26 years). Among the staff nurses, two had cared for patients on CGM during 4-6 shifts, one for 1-3 shifts and 1 for 7-10 shifts. The MICU nurse leaders (n=3) J o u r n a l P r e -p r o o f reported each assisting with CGM insertion, nursing education or trouble shooting on 4-6 patients. The Diabetes Consult NPs (n=2) reported caring for 7-10 and >10 consult patients with CGM.

We identified four major themes, Accuracy, Nursing Ownership, Workflow, and Barriers & Suggestions, presented within the three core elements of the PARIHS framework (evidence, context, facilitation). 27 Evidence was derived from the clinical experience of the MICU nurses, consistent with PARIHS definitions. Context included elements about organizational and unit culture, leadership, education, and initial evaluation of use. Facilitation include internal facilitation for streamlined CGM use within the unit and suggested improvements for future use. 27 The major themes and interconnecting subthemes from the focus group data are presented within this PARIHS framework. Table 2 presents major themes and subthemes along with supporting nursing statements.

All participants had positive perceptions regarding the accuracy of the CGM systems. Six of the 9 participants commented that they never experienced any inaccuracies in which the POC and CGM values fell outside the 20% or 20mg/dl threshold for values under 100mg/dl. Table 2 presents Accuracy's subthemes along with supporting nursing statements.

Initial validation. While 5 nursing participants stated they were aware that the CGM values might not be as accurate during the first 24 hours, most reported the CGM systems were validated quickly, typically 2 hours after the first CGM reading or 4 hours after insertion. While device calibration was not mentioned in the protocol or educational materials, several MICU leaders did mention occasionally calibrating CGM systems if accuracy was not initially obtained.

J o u r n a l P r e -p r o o f Patient condition. Two participants, a MICU staff nurse and Diabetes NP, discussed 2 examples of inaccuracy. In one case, the CGM was validated within the first 2 POC readings, however values for the subsequent 12 hours were slightly outside the 20% required range before finally regaining and sustaining accuracy. Inaccuracies in this case were attributed to changes in the patient's condition prompting adjustments in the tube feed regimen and initiation of steroids.

In the second instance, the NP reported inaccuracies attributed to the close proximity of a cooling blanket. The sensor was re-positioned on the patient's abdomen which resolved the issue.

Watch it. Nurses stated they were likely to accept the CGM glucose values, and use those values to titrate the IV insulin, knowing they could continue to monitor the readings. Nurses felt that the ability to continuously monitor glucose values presented a safer alternative to traditional POC glucose testing.

The major themes of Nursing Ownership and Workflow, their subthemes, and supporting nursing statements are presented in Table 3 .

Despite its novelty, there was surprising acceptance of CGM technology among MICU nurses.

Interestingly that acceptance did not as readily extend to other members of the MICU care team.

Nurses readily and organically took on the bulk of implementation activities including training and patient selection.

Acceptance. Nurses seemed to readily accept and incorporate the technology into the MICU and expressed a desire for continued and expanded use beyond the COVID pandemic and population. While there was general sentiment and description of the technology within the nursing domain, one nurse expressed a desire for "nursing ownership".

Training. Training on both the CGM and the protocol appeared to be very organic and nurse driven. Several, nurses described receiving initial training from a CNS or from a nurse manager; however, others described receiving training from other nurses who had developed CGM experience. The Diabetes Consult NP team played an essential role in ongoing support especially when managing more difficult patients or trouble shooting a device issue.

Patient selection. Patient selection and CGM initiation was described as a nursing driven process. Initially, patient selection was driven by the MICU CNS team; however, once nursing became more comfortable and gained experience using the CGM systems, they began promoting use. The MICU intensivist teams have little involvement in initiating CGM and nurses described encountering confusion and occasionally pushback from MICU providers regarding initiation of therapy.

Nurses discussed use of the devices and protocol and how CGM changed aspects of their workflow.

Decreased exposure. Nurses described significant changes to workflow and glucose management associated with the addition of CGM. The ability to monitor glucose from outside the COVID patient rooms allowed nursing to spend significantly less time in the room. Eyeball. In addition to viewing the glucose value, nurses evaluated glucose trends. They all referred to the trend arrow as the "eyeball", due to the shape of the icon on the display. Most nurses reported that while they were aware of the trend arrow, it did not really impact their treatment or IV insulin titration. However, one nurse indicated that the trend arrows did factor into an adjustment she might make within the IV guideline parameters.

CGM Insertion. Sensor insertion was thought to be very easy and quick. There was a sense that the time savings experienced once the device was validated was well worth the small amount of time required for insertion. Training surrounding device insertion was transmitted between nurse managers and CNSs through demonstration and the sharing of valuable lessons learned. One Diabetes NP shared 2 instances in which she experienced difficulty during device insertion despite having worn a Dexcom CGM for many years herself. One involved the novelty of wearing gloves while managing adhesive backing and the other involved not fully pushing the transmitter in place.

Nursing participants were asked what changes they would recommend for current and longstanding CGM use in the MICU. Table 4 presents subthemes along with supporting nursing statements. Perceived barriers and nursing recommendations for future use were as follows:

EHR & technology integration. Suggestions including the need for an improved documentation system and EHR integration. The need for nursing to annotate "cgm" within the POC glucose EHR field was seen as cumbersome and was thus inconsistently performed. Nurses commented that while they appreciated the technology, the receiver, phone, cords, and associated protocols and training materials crowded their workstations. Nurses exclusively used the J o u r n a l P r e -p r o o f receivers to view CGM data and remarked that the phones "never worked" and were rarely successfully paired.

Protocol simplification. There was unanimous consensus that the hybrid CGM + POC protocol was excessively lengthy and nurses expressed a desire for simplification. Nurses reported that confusion surrounding CGM use and the protocol was most likely to occur after insertion during the validation period. This was especially true if the validation period coincided with nursing shift change. Additionally, it was acknowledged that the need to perform mathematical calculations could be a barrier for some nurses. One nurse suggested automatic EMR mathematical calculations in the future.

There was general consensus that the CGM sensor insertion process was uncomplicated and quick. CGM sensor insertion was being done by MICU CNSs, nurse managers, and Diabetes Consult NPs. Participants felt MICU staff nurses were absolutely capable of performing CGM sensor insertions, however, it was recommended that for future and potentially more widespread use, training be extended to only charge nurses initially.

This report and evaluation highlight successful implementation of CGM in a MICU among COVID-19 patients using a hybrid POC plus CGM approach. Expanded inpatient CGM use holds promise to reduce healthcare worker exposure, conserve PPE, improve hospital efficiencies, and reduce costs, while improving glycemic control.

The cohort of nurses who participated in the MICU focus group represented 3 distinct subsets of nursing care in the MICU (e.g., nursing leaders, staff nurses, Diabetes Consult NPs).

Focus group data demonstrated the distinct but integrated roles of these three nursing groups in CGM implementation. Nursing appeared to readily accept and integrate CGM technology into J o u r n a l P r e -p r o o f the MICU environment. They felt the devices were accurate with the majority reporting all CGM/POC paired values within target. Interestingly, any reported inaccuracies were attributed to the critical nature of the patients rather than the technology itself.

There was a strong sense that this was a nursing intervention and a desire to keep the technology as a readily available tool. Patient selection was primarily driven by nursing, initially by the CNS and then the MICU staff nurse. Barriers encountered in patient selection included insufficient knowledge among the ICU care teams regarding CGM availability and use. Rather than use CGM to facilitate IV insulin, teams tended to use subcutaneous insulin in patients without severe refractory hyperglycemia. This is compounded by a lack of strong evidence from randomized controlled trials for a specific glucose target in MICU patients. [30] [31] [32] In addition, Recommendations for future use included improvements to EHR documentation. While nurses did appear to be documenting CGM values as a substitute for hourly POC, the annotation J o u r n a l P r e -p r o o f of "CGM" did not consistently occur despite frequent reinforcement. This was certainly substantiated by focus group data. A distinct field in the EHR dedicated to CGM glucose would help alleviate many documentation issues for nursing, but it was not possible to customize this for COVID-19 patients only. The failure of the Android phones to pair in many cases (13 or 19 phones did not pair), despite their connection to secure Wifi, was likely due to firewall protections that will need to be considered in the future. Glucose telemetry systems using the Dexcom Share feature have also been described. 33 However, no commercial system currently integrates with the EHR or with intravenous insulin software programs.

Additional considerations not addressed in the focus group data include streamlining the device set-up procedures.. While nurses reported successful implementation of device insertion and receiver pairing, retooling Dexcom G6 personal CGM for inpatient use required considerable time and effort and this process should be streamlined to facilitate widespread implementation.

The study was limited by several factors including the small sample size that is inherent to focus groups. Additionally, the focus group was at a single large academic medical center which could limit generalizability of experiences and implementation strategies.

This report demonstrates the feasibility of CGM integration in the ICU in response to the COVID-19 pandemic using an implementation science approach. The emerging use of CGM in the critical care environment holds tremendous promise to improve healthcare efficiencies, reduce cost and improve glycemic control; however, there is need for further research to quantify changes to nursing workflow, implementation burden, and associated economic implications.

J o u r n a l P r e -p r o o f The IV insulin infusion was titrated every hour using the POC BG value until initial validation was achieved. Then titration was performed using the CGM unless Q6 hour sensor meter pairs were discordant or other exception criteria occurred. Additional sensors could be placed if the patient had ongoing IV insulin requirements following initial sensor expiration or removal.

When patients were transitioned off IV insulin, Q6 hour POC testing was continued along with adjunctive CGM while in the MICU or until sensor expiration. Once transferred to a medical surgical floor, CGM could be used non-adjunctively (to replace POC testing) according to the institution's global Hyperglycemia in COVID-19 Patients guideline. The Diabetes Consult

Service utilized Dexcom Clarity, which operates on a 3-hour delay, to retrospectively visualize patient data and analyze glucose trends.

J o u r n a l P r e -p r o o f Due to concern that CGM would be inappropriately utilized outside of COVID-19 patients, a separate row for CGM data was not added to the glucose flowsheet in the electronic health record (EHR). In order to distinguish CGM values from POC, nurses used a "CGM" annotation which appears when hovering over the value with the mouse. Per usual practice, all POC BG values were manually entered into the glucose flowsheet at the time of acquisition and POC devices were downloaded once each shift as per usual practice. Downloaded POC values also automatically populate a separate row in the glucose flowsheet.

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J o u r n a l P r e -p r o o f• The use of continuous glucose monitoring (CGM) in the treatment of intensive care unit (ICU) COVID-19 patients holds tremendous potential to reduce healthcare worker exposure, conserve valuable personal protective equipment, and improve glycemic control during this unprecedented pandemic yet, there remain challenges in the operationalization of outpatient CGM devices for inpatient use. • While several manuscripts discuss the utility of CGM during the COVID-19 pandemic, this manuscript is the first to share a protocol and report data on CGM implementation in the ICU environment. • We created a Hybrid CGM plus point of care (POC) nurse driven guideline for implementation of Dexcom CGM in the ICU in which criteria for establishing initial sensor-meter agreement within each individual patient is outlined followed by hybrid use of CGM and POC measures. • We conducted a focus group among nurses in the MICU environment focused on uncovering data on implementation, perceived accuracy, changes to workflow, and identification of barriers and facilitators for use.J o u r n a l P r e -p r o o f

☒ The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.☐The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:J o u r n a l P r e -p r o o f