Risks in the analogue and digitally-supported medication process and potential solutions to increase patient safety in the hospital: A mixed methods study.

BACKGROUND: In hospital medication errors are common. Our aim was to investigate risks of the analogue and digitally-supported medication process and any potential solutions. METHODS: A mixed methods study including a structured literature search and online questionnaires based on the Delphi method was conducted. First, all risks were structured into main and sub-risks and second, risks were grouped into risk clusters. Third, healthcare experts assessed risk clusters regarding their likelihood of occurrence their possible impact on patient safety. Experts were also asked to estimate the potential for digital solutions and solutions that strengthen the competence of healthcare professionals. RESULTS: Overall, 160 main risks and 542 sub-risks were identified. Main risks were grouped into 43 risk clusters. 33 healthcare experts (56% female, 50% with >20 years professional-experience) ranked the likelihood of occurrence and the impact on patient safety in the top 15 risk clusters regarding the process steps: admission (n = 4), prescribing (n = 3), verifying (n = 1), preparing/dispensing (n = 3), administering (n = 1), discharge (n = 1), healthcare professional competence (n = 1), and patient adherence (n = 1). 28 healthcare experts (64% female, 43% with >20 years professional-experience) mostly suggested awareness building and training, strengthened networking, and involvement of pharmacists at point-of-care as likely solutions to strengthen healthcare professional competence. For digital solutions they primarily suggested a digital medication list, digital warning systems, barcode-technology, and digital support in integrated care. CONCLUSIONS: The medication process holds a multitude of potential risks, in both the analogue and the digital medication process. Different solutions to strengthen healthcare professional competence and in the area of digitalization were identified that could help increase patient safety and minimize possible errors.

Reply to Freckmann et al. Comment on "Hochfellner et al. Accuracy Assessment of the GlucoMen® Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study. Biosensors 2022, 12, 106".

We thank Dr. Freckmann et al. [...].

Accuracy Assessment of the GlucoMen® Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study.

The aim of this study was to evaluate the accuracy and usability of a novel continuous glucose monitoring (CGM) system designed for needle-free insertion and reduced environmental impact. We assessed the sensor performance of two GlucoMen® Day CGM systems worn simultaneously by eight participants with type 1 diabetes. Self-monitoring of blood glucose (SMBG) was performed regularly over 14 days at home. Participants underwent two standardized, 5-h meal challenges at the research center with frequent plasma glucose (PG) measurements using a laboratory reference (YSI) instrument. When comparing CGM to PG, the overall mean absolute relative difference (MARD) was 9.7 [2.6-14.6]%. The overall MARD for CGM vs. SMBG was 13.1 [3.5-18.6]%. The consensus error grid (CEG) analysis showed 98% of both CGM/PG and CGM/SMBG pairs in the clinically acceptable zones A and B. The analysis confirmed that GlucoMen® Day CGM meets the clinical requirements for state-of-the-art CGM. In addition, the needle-free insertion technology is well tolerated by users and reduces medical waste compared to conventional CGM systems.

Digital algorithm-guided insulin therapy in home healthcare for elderly persons with type 2 diabetes: A proof-of-concept study.

GlucoTab@MobileCare, a digital workflow and decision support system with integrated basal and basal-plus insulin algorithm was investigated for user acceptance, safety and efficacy in persons with type 2 diabetes receiving home health care by nurses. During a three months study nine participants (five female, age 77 ± 10 years, HbA1c 60 ± 13 mmol/mol (study start) vs. 57 ± 12 mmol/mol (study end) received basal or basal-plus insulin therapy as suggested by the digital system. In total 95% of all suggested tasks (blood glucose (BG) measurements, insulin dose calculations, insulin injections) were performed according to the digital system. Mean morning BG was 171 ± 68 mg/dL in the first study month vs. 145 ± 35 mg/dL in the last study month, indicating a reduced glycemic variability of 33 mg/dL (standard deviation). No hypoglycemic episode < 54 mg/dL occurred. User's adherence was high and the digital system supported a safe and effective treatment. Larger scale studies are needed to confirm findings under routine care. German Clinical Trials Register ID: DRKS00015059.

Evaluation of an implemented new insulin chart to improve quality and safety of diabetes care in a large university hospital: a follow-up study.

OBJECTIVES: To evaluate structure, documentation, treatment quality of a new implemented standardised insulin chart in adult medical inpatient wards at a university hospital. DESIGN: A before-after study (3 to 5 months after implementation) was used to compare the quality of old versus new insulin charts. SETTING: University Hospital Graz, Austria. PARTICIPANTS: Healthcare professionals (n=237) were questioned regarding structure quality of blank insulin charts. INTERVENTIONS: A new standardised insulin chart was implemented and healthcare professionals were trained regarding features of this chart. Data from insulinised inpatients were evaluated regarding documentation and treatment quality of filled-in insulin charts (n=108 old insulin charts vs n=100 new insulin charts). MAIN OUTCOMES AND MEASURES: The primary endpoint was documentation error for insulin administration. RESULTS: Healthcare professionals reported an improved structure quality of the new insulin chart with a Likert type response scale increase in all nine items. Documentation errors for insulin administration (primary endpoint) occurred more often on old than new insulin charts (77% vs 5%, p<0.001). Documentation errors for insulin prescription were more frequent on old insulin charts (100% vs 42%) whereas documentation errors for insulin management rarely occurred in any group (10% vs 8%). Patients of both chart evaluation groups (age: 71±11 vs 71±12 years, 47% vs 42% women, 75% vs 87% type 2 diabetes for old vs new charts, respectively) had a mean of 4±2 good diabetes days. Overall, 26 vs 18 hypoglycaemic episodes (blood glucose (BG) <4.0 mmol/L (72 mg/dL), p=0.28), including 7 vs 2 severe hypoglycaemic episodes (BG <3.0 mmol/L (54 mg/dL), p=0.17) were documented on old versus new insulin charts. CONCLUSIONS: The implementation of a structured documentation form together with training measures for healthcare professionals led to less documentation errors and safe management of glycaemic control in hospitalised patients in a short time follow-up. A rollout at further medical wards is recommended, and sustainability in the long-term has to be demonstrated.

Limited Documentation and Treatment Quality of Glycemic Inpatient Care in Relation to Structural Deficits of Heterogeneous Insulin Charts at a Large University Hospital.

OBJECTIVES: Insulin charts represent a key component in the inpatient glycemic management process. The aim was to evaluate the quality of structure, documentation, and treatment of diabetic inpatient care to design a new standardized insulin chart for a large university hospital setting. METHODS: Historically grown blank insulin charts in use at 39 general wards were collected and evaluated for quality structure features. Documentation and treatment quality were evaluated in a consecutive snapshot audit of filled-in charts. The primary end point was the percentage of charts with any medication error. RESULTS: Overall, 20 different blank insulin charts with variable designs and significant structural deficits were identified. A medication error occurred in 55% of the 102 audited filled-in insulin charts, consisting of prescription and management errors in 48% and 16%, respectively. Charts of insulin-treated patients had more medication errors relative to patients treated with oral medication (P < 0.01). Chart design did support neither clinical authorization of individual insulin prescription (10%), nor insulin administration confirmed by nurses' signature (25%), nor treatment of hypoglycemia (0%), which resulted in a reduced documentation and treatment quality in clinical practice 7%, 30%, 25%, respectively. CONCLUSIONS: A multitude of charts with variable design characteristics and structural deficits were in use across the inpatient wards. More than half of the inpatients had a chart displaying a medication error. Lack of structure quality features of the charts had an impact on documentation and treatment quality. Based on identified deficits and international standards, a new insulin chart was developed to overcome these quality hurdles.

Electronic Diabetes Management System Replaces Paper Insulin Chart: Improved Quality in Diabetes Inpatient Care Processes Due to Digitalization.

BACKGROUND: GlucoTab, an electronic diabetes management system (eDMS), supports healthcare professionals (HCPs) in inpatient blood glucose (BG) management at point-of-care and was implemented for the first time under routine conditions in a regional hospital to replace the paper insulin chart. METHOD: To investigate quality of the eDMS for inpatients with type 2 diabetes mellitus a monocentric retrospective before-after evaluation was conducted. We compared documentation possibilities by assessing a blank paper chart vs the eDMS user interface. Further quality aspects were compared by assessing filled-in paper charts (n = 106) vs filled-in eDMS documentation (n = 241). HCPs (n = 59) were interviewed regarding eDMS satisfaction. RESULTS: The eDMS represented an improvement of documentation possibilities by offering a more structured and comprehensive user interface compared to the blank paper chart. The number of good diabetes days averaged to a median value of four days in both groups (paper chart: 4.38 [0-7] vs eDMS: 4.38 [0-7] days). Median daily BG was 170 (117-297) mg/dL vs 168 (86-286) mg/dL and median fasting BG was 152 (95-285) mg/dL vs 145 (69-333) mg/dL, and 0.1% vs 0.4% BG values <54 mg/dL were documented. Diabetes documentation quality improved when using eDMS, for example, documentation of ordered BG measurement frequency (1% vs 100%) and ordered BG targets (0% vs 100%). HCPs stated that by using eDMS errors could be prevented (74%), and digital support of work processes was completed (77%). Time saving was noted by 8 out of 11 HCPs and estimated at 10-15 minutes per patient day by two HCPs. CONCLUSIONS: The eDMS completely replaced the paper chart, showed comparable glycemic control, was positively accepted by HCPs, and is suitable for inpatient diabetes management.

Study protocol for assessing the user acceptance, safety and efficacy of a tablet-based workflow and decision support system with incorporated basal insulin algorithm for glycaemic management in participants with type 2 diabetes receiving home health care: A single-centre, open-label, uncontrolled proof-of-concept study.

INTRODUCTION: Diabetes management can be especially complex for older adults who receive health care at home. Thus, international guidelines recommend basal-insulin regimens due to simpler handling and low hypoglycaemia risk. A basal-insulin algorithm (including basal-plus) was developed to also include participant's health status and subsequently implemented into a tablet-based workflow and decision support system, GlucoTab@MobileCare. This study protocol describes a proof-of-concept study to investigate user acceptance, safety and efficacy of the GlucoTab@MobileCare system in participants receiving home health care. METHODS: The open-label, single-centre, uncontrolled study will recruit a maximum of ten participants with insulin treated type-2-diabetes (age ≥18 years) who receive home health care. During a three month study period participants will receive basal- or basal-plus-insulin therapy once daily as suggested by the GlucoTab@MobileCare system. Statistical analysis will be conducted on an intention-to-treat basis. The primary endpoint is the percentage of tasks (BG measurements, insulin dose calculations, insulin injections) that were performed according to GlucoTab@MobileCare suggestions relative to the total of suggested tasks. Secondary endpoints include user acceptance, safety and efficacy parameters. The study was approved by the ethics committee and regulatory authorities. Before obtaining written informed consent, all participants will receive oral and written information about all aspects of the study. Results will be published in a peer-reviewed journal and at diabetes and geriatric conferences. DISCUSSION: Potential implications may be improved quality and safety of basal-insulin therapy in older adults as well as support for health-care-providers in daily routine including evidence-based knowledge. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00015059).