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NCT Number: NCT05447806

Diabetes Clinical Decision Support

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center, Hershey, Pennsylvania, United States

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About this study

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 academic and community hospitals. This resource will be available intermittently in the EMR every 3 months for 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 four community hospitals. 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 four 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 four community hospital. The study received an IRB waiver of consent for the inclusion of subjects identified in the electronic health record. The consent of clinicians participating in study surveys is implied by agreeing to respond to surveys. It is hypothesized that the tool will increase providers' knowledge and decision making to manage dysglycemia allowing them to make better decisions about insulin administration. It is also hypothesized that clinical and economic outcomes will be better during the time alert-CDS is available. The anticipated success of our study builds upon a well-established multidisciplinary team of investigators strongly supported by leadership stakeholders in hospitals within a health system. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children (<18 years)

Treatment and study plan

Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support

Device

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.

Primary outcomes

  1. Average hospital length of stay (LOS)

    Time frame: Duration of hospital admission, up to 3 months

    Number of days in the hospital

Secondary outcomes

  1. Proportion of gap in care events

    Time frame: Duration of hospital admission, up to 3 months

    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].

  2. Glycemic control parameters - Glucose metrics

    Time frame: Duration of hospital admission, up to 3 months

    Average glucose per admission, glucose range (Glucose value in mg/dl)

  3. Glycemic control parameters - average glucose per day per admission

    Time frame: Duration of hospital admission, up to 3 months

    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).

  4. Glycemic control parameters - glycemic variability

    Time frame: Duration of hospital admission, up to 3 months

    Standard deviation

  5. Incidence of inpatient mortality

    Time frame: Duration of hospital admission, up to 3 months

    Number of deceased patients

  6. Incidence of post-discharge mortality

    Time frame: Up to 3 months after discharge

    Number of deceased patients

  7. Proportion of hospital-acquired infections

    Time frame: Duration of hospital admission, up to 3 months

    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 7)Vancomycin Resistant Enterococcus 8)Skin and soft tissue infection (SSI) 9)Ventilator Acquired Pneumonia

  8. Proportion of surgical complications

    Time frame: Duration of hospital admission, up to 3 months

    Number of complications: 1)Wound dehiscence 2)Seroma 3)Surgical site infection 4)Acute organ rejection 5)Ventral/Ruptured Hernia 6)Ileus

  9. Proportion of medical complications

    Time frame: Duration of hospital admission, up to 3 months

    Number of complications: 1) Systemic inflammatory response syndrome SIRS 2)Sepsis 3)Severe sepsis 4)Septic shock 5)Decubitus ulcers 6)Deep venous thromboembolism 7)Pulmonary embolism 8)Diabetes ketoacidosis (DKA) 9)Hypoglycemia 10)Delirium 11)Encephalopathy 12)Mental status changes/altered mental status 13)Acute respiratory failure 14)Acute kidney injury/failure 15)Acute coronary syndrome/acute MI 16)Heart failure exacerbation 17)Stroke 18)Ventilatory support 19)Seizures 20)Coma 21)Irreversible neurologic injury 22)QT prolongation 23)Ventricular arrhythmias 24)Atrial arrhythmias 25)Sudden cardiac death 26)3)Fall occurred during hospitalization.

  10. Proportion of safety events

    Time frame: Duration of hospital admission, up to 3 months

    Number of events: 1)Diabetes Ketoacidosis diagnosis in type 1 diabetes after sliding scale insulin monotherapy gap in care event notification 2)Severe hypoglycemia (glucose level <= 40 mg/dl) after any hypoglycemia or hyperglycemia gap in care event notification 3)Hyperosmolar hyperglycemia state in type 2 diabetes after sliding scale insulin monotherapy gap in care event notification

  11. Frequency of severity of illness

    Time frame: Duration of hospital admission, up to 3 months

    Number of cases during hospitalization: Diagnosis Related Group (DRG) SOI categories 1, 2, 3, and 4.

  12. Proportion of diabetes medication optimization at the transition of care

    Time frame: Duration of hospital admission, up to 3 months

    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).

  13. Average reduction of glycohemoglobin level within 12 months of discharge

    Time frame: up to 12 months after being discharged from the hospital

    Percent level reduction: Glycohemoglobin reduction in relation to level prior to admission among patients who continue to follow with the health system

  14. Frequency of hospital readmission

    Time frame: Up to 30 days after being discharged from the hospital

    Number of admissions: Admission within 7, 14, and 30 days from discharge.

  15. Frequency of Intensive Care unit (ICU) transfers

    Time frame: Duration of hospital admission, up to 3 months

    Number of transfers: Refers to admission to ICU transferred from non-ICU units

  16. Cost of hospitalization

    Time frame: Duration of hospital admission, up to 3 months

    Log-transformed amount of hospital submitted claims

  17. Frequency of post-hospitalization skilled care needed from home to more advanced care

    Time frame: Duration of hospital admission, up to 3 months

    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.

  18. Frequency of post-hospitalization skilled care needed

    Time frame: Duration of hospital admission, up to 3 months

    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.

  19. Frequency of utilization of consulting services resource

    Time frame: Duration of hospital admission, up to 3 months

    Number of consults to diabetes services (endocrinology, diabetes education, hospitalists).

  20. Hospital revenue

    Time frame: Duration of hospital admission, up to 3 months

    Number in category of DRG for expected reimbursement

Other outcomes

  1. Provider's perspective

    Time frame: Up to 48 months

    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).

  2. Provider's knowledge

    Time frame: Up to 48 months

    Multiple choice questions correct responses: Refers to question on contextual and biomedical knowledge

  3. Provider's decision making

    Time frame: Up to 48 months

    Proportion of correct responses: Clinical vignettes representing common clinical scenario of glucose management in the hospital

  4. Provider's practice performance

    Time frame: Up to 48 months

    Number of insulin treatment adjustments.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariana Pichardo-Lowden, MD

CONTACT

[email protected]

7175310003 ext. 281452

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 7, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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