Clinical trial NCT05447806: Diabetes Clinical Decision Support
Official title: Glucose Management Clinical Decision Support to Improve Outcomes in Academic and Community Hospitals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperglycemia
Hyperglycemia Stress
Diabetes
PreDiabetes
Hypoglycemia
Keywords: Clinical Decision Support
Electronic Medical Records
Health Systems Science
Hospital Management
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-07-07
Enrollment: 15732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective quasi-experiment will use an interrupted time series analysis to determine the impact of our novel glucose management CDS tool on the care of adult hospitalized patients outside of intensive care units in an academic and a community hospital. The tool will be intermittently active in the EMR hospital-wide every 3 months during 36-months to enable an intervention (active) and a control (inactive) group of 18 months each in each hospital.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Average hospital length of stay (LOS)
timeFrame: Duration of hospital admission, up to 6 weeks
Secondary outcomes:
measure: Proportion of gap in care events
timeFrame: Duration of hospital admission, up to 3 months
measure: Glycemic control parameters - average glucose per admission
timeFrame: Duration of hospital admission, up to 3 months
measure: Glycemic control parameters - average glucose per day per admission
timeFrame: Duration of hospital admission, up to 3 months
measure: Glycemic control parameters - glycemic variability
timeFrame: Duration of hospital admission, up to 3 months
measure: Incidence of inpatient mortality
timeFrame: Duration of hospital admission, up to 3 months
measure: Incidence of post-discharge mortality
timeFrame: Up to 3 months after discharge
measure: Proportion of hospital-acquired infections
timeFrame: Duration of hospital admission, up to 3 months
measure: Proportion of surgical complications
timeFrame: Duration of hospital admission, up to 3 months
measure: Proportion of medical complications
timeFrame: Duration of hospital admission, up to 3 months
measure: Proportion of safety events
timeFrame: Duration of hospital admission, up to 3 months
measure: Frequency of severity of illness
timeFrame: Duration of hospital admission, up to 3 months
measure: Proportion of diabetes medication optimization at the transition of care
timeFrame: Duration of hospital admission, up to 3 months
measure: Average reduction of glycohemoglobin level within 12 months of discharge
timeFrame: up to 12 months after being discharged from the hospital
measure: Frequency of hospital readmission
timeFrame: Up to 30 days after being discharged from the hospital
measure: Frequency of Intensive Care unit (ICU) transfers
timeFrame: Duration of hospital admission, up to 3 months
measure: Cost of hospitalization
timeFrame: Duration of hospital admission, up to 3 months
measure: Frequency of post-hospitalization skilled care needed from home to more advanced care
timeFrame: Duration of hospital admission, up to 3 months
measure: Frequency of post-hospitalization skilled care needed
timeFrame: Duration of hospital admission, up to 3 months
measure: Frequency of utilization of consulting services resource
timeFrame: Duration of hospital admission, up to 3 months
measure: Hospital revenue
timeFrame: Duration of hospital admission, up to 3 months
Other outcomes:
measure: Provider's perspective
timeFrame: Up to 24 months
measure: Provider's knowledge
timeFrame: Up to 24 months
measure: Provider's decision making
timeFrame: Up to 24 months
measure: Provider's practice performance
timeFrame: Up to 24 months
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Reading
country: United States
facility: Penn State Health St. Joseph Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Ariana Pichardo-Lowden, MD
role: PRINCIPAL_INVESTIGATOR
References: