Diabetes Clinical Decision Support

Glucose Management Clinical Decision Support to Improve Outcomes in Academic and Community Hospitals

The purpose of this study is to determine the impact of an electronic medical record clinical decision support tool on rates of dysglycemia in the hospital, and its clinical and economical outcomes. The study also evaluates the perspectives of providers regarding the tool's usefulness on disease management support, knowledge, and practice performance.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Hypoglycemia; Diabetes; PreDiabetes; Hyperglycemia Stress
• Intervention / Treatment: Device: Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support

Detailed Description

Approximately 9 million patients with diabetes (DM) are hospitalized annually and over 30% of inpatients without DM experience high glucose (HG) due to their acute illness. HG increases the risk of infectious and non- infectious complications and death, hospital length of stay (LOS), utilization of hospital resources and overall healthcare costs. While glucose control reduces these risks, controlling HG in the hospital is difficult due to multiple barriers such as recognizing and proactively treating glucose abnormalities, and adequately ordering insulin to treat HG in the hospital. Clinical decision support (CDS) is a system that uses computerized person- specific data in the electronic medical record (EMR) proven to improve hospital care. Among the various modalities, alert-CDS is shown to improve care delivery, providers' proactivity, and glucose control specifically in intensive care settings of academic institutions. However, alert-CDS has not yet been studied outside of intensive care units (ICU), or in community hospitals where most patients receive care. Furthermore, its impact on patients' outcomes has not been tested in any setting. The proposed project uses an innovative alert-CDS tool the investigators developed and validated which automatically identifies dysglycemia and inadequacies in insulin administration in the hospital. It alerts clinicians with recommendations to support decision making without superseding their clinical judgement. In the pilot study, it was found that this alert-CDS tool reduced recurrent high glucose levels and shortened LOS. Based on this promising preliminary data, in this project the investigators propose to study the impact of our CDS tool on clinical, economic and providers' performance outcomes among non-intensive care patients both in an academic and a community hospital. This resource will be available intermittently in the EMR every 3 months during 36 months, thus allowing the comparison of 18 months of intervention and 18 months of standard care. Based on the pilot study, a sample size of 12,560 subjects will give an 80% power of detecting 0.34 days (~ 8 hours) difference in length of stay, the primary endpoint of our study. The investigators propose the following aims: Aim 1) To determine the impact of the alert-CDS over conventional care on the clinical outcomes of non-ICU patients in an academic and a community hospital. Aim 2) To determine the impact of the alert-CDS over conventional care on the economic outcomes of non-ICU patients in an academic and a community hospital. Aim 3) To determine the impact of alert-CDS for inpatient glycemic control on providers' perspectives, competencies and practice performance between an academic and a community hospital. It is hypothesized that the tool will increase providers' knowledge about dysglycemia allowing them to make better decisions about insulin administration. The anticipated success of our study builds upon a well-established multidisciplinary team of investigators strongly supported by leadership stakeholders in both hospitals. The proposed study has the potential of establishing a new paradigm in the management of dysglycemia in hospitalized patients with a major positive impact on clinical and economic outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 15732
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kalen Coordinator, MS; Phone Number: 281452 7175310003; Email: kkearcher@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Milton S. Hershey Medical Center
      • Contact: Kalen Coordinator, MS; Phone Number: 717-531-0003; Email: kkearcher@pennstatehealth.psu.edu
    • Reading, Pennsylvania, United States, 19605
      • Recruiting
      • Penn State Health St. Joseph Medical Center
      • Contact: Franciss Quigley, MD; Phone Number: 610-378-2440; Email: fquigley@pennstatehealth.psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hospitalized adult (>18 years) patients at Penn State Health, Hershey Medical Center, St. Joseph's Hospital, Hampden Medical Center, and Holy Spirit Medical Center
• Ambulatory adult (>18 years) patients at Penn State Health, Hershey Medical Center
• Trigger of an alert or a disease management message

Exclusion Criteria:

• Children (<18 years)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Inpatient Diabetes Clinical Decision Support; The Active arm consists of participants treated during the "ON" phase of the GlucAlert-CDS tool. The tool operates through an automated process of rules embedded in the EMR recognizing hypoglycemia (established or impending); recurrent hyperglycemia (in type 1 and 2 DM, or stress hyperglycemia-SH); and inappropriate insulin use (sliding scales monotherapy if recurrent hyperglycemia in type 2 DM or SH, or any time in type 1 DM). If the tool's criteria are met, an alert in the EMR will notify the provider with the clinically recommended treatment.	Device: Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support; This prospective intervention will be carried out over 36 months and encompass 12 alternating GlucAlert-CDS phases lasting 3 months each. Six active phases (ON period) and six inactive phases (OFF period) will represent 18 months of intervention and control respectively. GlucAlert-CDS recognizes gaps in care denoting the automatic process of subjects' identification and inclusion. During the ON period, gap in care events detected in patients' EMR will evoke alert messages and care recommendations for clinicians in real time for their consideration. These notifications are programmed to be delivered to primary inpatient providers in direct care of these hospitalized patients. During the OFF period, the program will record the gaps in care events detected, but alerts will be inactive for providers' viewing.
No Intervention: Inactive Inpatient Diabetes Clinical Decision Support; The Inactive arm consists of participants treated during the "OFF" phase of the GlucAlert-CDS Tool. Alerts will not be sent to provider's

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average hospital length of stay (LOS)	Number of days in the hospital	Duration of hospital admission, up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of gap in care events	Number of events recognized for: 1) Hyperglycemia: recurrent hyperglycemia [>= 180/dl at least twice] or severe hyperglycemia [>= 250 mg/dl at least once] 2) Hypoglycemia: established hypoglycemia [<= 70 mg/dl] or impending hypoglycemia [71-80 mg/dl] 3)Inappropriate insulin use: among type 2 diabetes and stress hyperglycemia patients [sliding scale monotherapy when recurrent hyperglycemia present] or among type 1 diabetes [sliding scale monotherapy any time].	Duration of hospital admission, up to 3 months
Glycemic control parameters - average glucose per admission	Glucose value in mg/dl	Duration of hospital admission, up to 3 months
Glycemic control parameters - average glucose per day per admission	Number of glucose values within the following categories: severe hypoglycemia (<= 40 mg/dl), moderate hypoglycemia (41-70 mg/dl), within normal limits but not desired (71-110 mg/dl), within target/less commonly recommended (111-140 mg/dl), within target (141-180 mg/dl), mild hyperglycemia (181-220 mg/dl), moderate hyperglycemia (221-300 mg/dl), severe hyperglycemia (>=301 mg/dl).	Duration of hospital admission, up to 3 months
Glycemic control parameters - glycemic variability	Standard deviation	Duration of hospital admission, up to 3 months
Incidence of inpatient mortality	Number of deceased patients	Duration of hospital admission, up to 3 months
Incidence of post-discharge mortality	Number of deceased patients	Up to 3 months after discharge
Proportion of hospital-acquired infections	Number of infections: 1)Hospital acquired pneumonia (HAP) 2)Catheter-associated urinary tract infections (CAUTI) 3)Clostridium difficile colitis 4)MRSA infections 5)Central Line associated Bloodstream Infection (CLABSI) 6)Bacteremia	Duration of hospital admission, up to 3 months
Proportion of surgical complications	Number of complications: 1)Wound dehiscence 2)Seroma 3)Surgical site infection 4)Acute organ rejection	Duration of hospital admission, up to 3 months
Proportion of medical complications	Number of complications: 1)Diabetes ketoacidosis (DKA) 2)Sepsis 3)Severe sepsis 4)Septic shock 5)Decubitus ulcers 6)Deep venous thromboembolism 7)Pulmonary embolism.	Duration of hospital admission, up to 3 months
Proportion of safety events	Number of events: 1)DKA diagnosis in type 1 diabetes after sliding scale insulin monotherapy gap in care event notification 2)Sever hypoglycemia (glucose level <= 40 mg/dl) after any hypoglycemia or hyperglycemia gap in care event notification 3)Fall occurred during hospitalization.	Duration of hospital admission, up to 3 months
Frequency of severity of illness	Number of cases during hospitalization: Diagnosis Related Group (DRG) SOI categories 1, 2, 3, and 4.	Duration of hospital admission, up to 3 months
Proportion of diabetes medication optimization at the transition of care	Number of participants: Patients with A1c > 8% having their diabetes treatment adjusted upon discharge, defined as a preadmission diabetes treatment changed to include additional medications (insulin, oral or non-insulin injectable agents).	Duration of hospital admission, up to 3 months
Average reduction of glycohemoglobin level within 12 months of discharge	Percent level reduction: Glycohemoglobin reduction in relation to level prior to admission among patients who continue to follow with the health system	up to 12 months after being discharged from the hospital
Frequency of hospital readmission	Number of admissions: Admission within 7, 14, and 30 days from discharge.	Up to 30 days after being discharged from the hospital
Frequency of Intensive Care unit (ICU) transfers	Number of transfers: Refers to admission to ICU transferred from non-ICU units	Duration of hospital admission, up to 3 months
Cost of hospitalization	Log-transformed amount of hospital submitted claims	Duration of hospital admission, up to 3 months
Frequency of post-hospitalization skilled care needed from home to more advanced care	Number of discharges higher than preadmission level of care: defined as discharge to more advanced care than previous to admission such as a) Inpatient advanced care facilities, b) rehabilitation, c) nursing home care.	Duration of hospital admission, up to 3 months
Frequency of post-hospitalization skilled care needed	Number of discharges higher than preadmission level of care: defined as discharge to more advanced care than previous to admission such as a) Inpatient advanced care facilities, b) rehabilitation, c) nursing home care.	Duration of hospital admission, up to 3 months
Frequency of utilization of consulting services resource	Number of consults to diabetes services (endocrinology, diabetes education, hospitalists).	Duration of hospital admission, up to 3 months
Hospital revenue	Number in category of DRG for expected reimbursement	Duration of hospital admission, up to 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider's perspective	5-point Likert scale responses of 1)Usefulness of CDS managing glucose issues 2)Importance of CDS in hospital diabetes care 3)Support of the CDS in own decision making 4)Sense of work disruption caused by the CDS messages 5)Sense of notification fatigue caused by the CDS messages. Providers will respond with their level of agreement to each question on a 5-point scale (from 1 - Strongly Disagree to 5 - Strongly Agree).	Up to 24 months
Provider's knowledge	Multiple choice questions correct responses: Refers to question on contextual and biomedical knowledge	Up to 24 months
Provider's decision making	Proportion of correct responses: Clinical vignettes representing common clinical scenario of glucose management in the hospital	Up to 24 months
Provider's practice performance	Number of insulin treatment adjustments.	Up to 24 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Ariana Pichardo-Lowden, MD, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): July 14, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Electronic Medical Records; Health Systems Science; Hospital Management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Hypoglycemia
• Other Study ID Numbers: STUDY00012931/20607; 1R01DK130992-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes