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Diabetes Clinical Decision Support

Primary Purpose

Hyperglycemia, Hyperglycemia Stress, Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hyperglycemia focused on measuring Clinical Decision Support, Electronic Medical Records, Health Systems Science, Hospital Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized adult (>18 years) patients at Penn State Health, Hershey Medical Center and St. Joseph's Hospital
  • 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)

Sites / Locations

  • Milton S. Hershey Medical CenterRecruiting
  • Penn State Health St. Joseph Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Inpatient Diabetes Clinical Decision Support

Inactive Inpatient Diabetes Clinical Decision Support

Arm Description

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.

The Inactive arm consists of participants treated during the "OFF" phase of the GlucAlert-CDS Tool. Alerts will not be sent to provider's

Outcomes

Primary Outcome Measures

Average hospital length of stay (LOS)
Number of days in the hospital

Secondary Outcome Measures

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].
Glycemic control parameters - average glucose per admission
Glucose value in mg/dl
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).
Glycemic control parameters - glycemic variability
Standard deviation
Incidence of inpatient mortality
Number of deceased patients
Incidence of post-discharge mortality
Number of deceased patients
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
Proportion of surgical complications
Number of complications: 1)Wound dehiscence 2)Seroma 3)Surgical site infection 4)Acute organ rejection
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.
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.
Frequency of severity of illness
Number of cases during hospitalization: Diagnosis Related Group (DRG) SOI categories 1, 2, 3, and 4.
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).
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
Frequency of hospital readmission
Number of admissions: Admission within 7, 14, and 30 days from discharge.
Frequency of Intensive Care unit (ICU) transfers
Number of transfers: Refers to admission to ICU transferred from non-ICU units
Cost of hospitalization
Log-transformed amount of hospital submitted claims
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.
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.
Frequency of utilization of consulting services resource
Number of consults to diabetes services (endocrinology, diabetes education, hospitalists).
Hospital revenue
Number in category of DRG for expected reimbursement

Full Information

First Posted
June 15, 2022
Last Updated
September 12, 2023
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05447806
Brief Title
Diabetes Clinical Decision Support
Official Title
Glucose Management Clinical Decision Support to Improve Outcomes in Academic and Community Hospitals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
July 14, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Hyperglycemia Stress, Diabetes, PreDiabetes, Hypoglycemia
Keywords
Clinical Decision Support, Electronic Medical Records, Health Systems Science, Hospital Management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
The study is single-blinded. Participants will be masked from the intervention due to the GlucAlert CDS tool only being viewed by physicians. Investigators will remain unblinded and know when the tool is turned "On" or "Off." The outcomes statisticians and assessors will analyze deidentified data and remain blinded for their analysis.
Allocation
Non-Randomized
Enrollment
15732 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Inpatient Diabetes Clinical Decision Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Inactive Inpatient Diabetes Clinical Decision Support
Arm Type
No Intervention
Arm Description
The Inactive arm consists of participants treated during the "OFF" phase of the GlucAlert-CDS Tool. Alerts will not be sent to provider's
Intervention Type
Device
Intervention Name(s)
Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support
Intervention Description
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 Outcome Measure Information:
Title
Average hospital length of stay (LOS)
Description
Number of days in the hospital
Time Frame
Duration of hospital admission, up to 6 weeks
Secondary Outcome Measure Information:
Title
Proportion of gap in care events
Description
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].
Time Frame
Duration of hospital admission, up to 3 months
Title
Glycemic control parameters - average glucose per admission
Description
Glucose value in mg/dl
Time Frame
Duration of hospital admission, up to 3 months
Title
Glycemic control parameters - average glucose per day per admission
Description
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).
Time Frame
Duration of hospital admission, up to 3 months
Title
Glycemic control parameters - glycemic variability
Description
Standard deviation
Time Frame
Duration of hospital admission, up to 3 months
Title
Incidence of inpatient mortality
Description
Number of deceased patients
Time Frame
Duration of hospital admission, up to 3 months
Title
Incidence of post-discharge mortality
Description
Number of deceased patients
Time Frame
Up to 3 months after discharge
Title
Proportion of hospital-acquired infections
Description
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
Time Frame
Duration of hospital admission, up to 3 months
Title
Proportion of surgical complications
Description
Number of complications: 1)Wound dehiscence 2)Seroma 3)Surgical site infection 4)Acute organ rejection
Time Frame
Duration of hospital admission, up to 3 months
Title
Proportion of medical complications
Description
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.
Time Frame
Duration of hospital admission, up to 3 months
Title
Proportion of safety events
Description
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.
Time Frame
Duration of hospital admission, up to 3 months
Title
Frequency of severity of illness
Description
Number of cases during hospitalization: Diagnosis Related Group (DRG) SOI categories 1, 2, 3, and 4.
Time Frame
Duration of hospital admission, up to 3 months
Title
Proportion of diabetes medication optimization at the transition of care
Description
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).
Time Frame
Duration of hospital admission, up to 3 months
Title
Average reduction of glycohemoglobin level within 12 months of discharge
Description
Percent level reduction: Glycohemoglobin reduction in relation to level prior to admission among patients who continue to follow with the health system
Time Frame
up to 12 months after being discharged from the hospital
Title
Frequency of hospital readmission
Description
Number of admissions: Admission within 7, 14, and 30 days from discharge.
Time Frame
Up to 30 days after being discharged from the hospital
Title
Frequency of Intensive Care unit (ICU) transfers
Description
Number of transfers: Refers to admission to ICU transferred from non-ICU units
Time Frame
Duration of hospital admission, up to 3 months
Title
Cost of hospitalization
Description
Log-transformed amount of hospital submitted claims
Time Frame
Duration of hospital admission, up to 3 months
Title
Frequency of post-hospitalization skilled care needed from home to more advanced care
Description
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.
Time Frame
Duration of hospital admission, up to 3 months
Title
Frequency of post-hospitalization skilled care needed
Description
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.
Time Frame
Duration of hospital admission, up to 3 months
Title
Frequency of utilization of consulting services resource
Description
Number of consults to diabetes services (endocrinology, diabetes education, hospitalists).
Time Frame
Duration of hospital admission, up to 3 months
Title
Hospital revenue
Description
Number in category of DRG for expected reimbursement
Time Frame
Duration of hospital admission, up to 3 months
Other Pre-specified Outcome Measures:
Title
Provider's perspective
Description
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).
Time Frame
Up to 24 months
Title
Provider's knowledge
Description
Multiple choice questions correct responses: Refers to question on contextual and biomedical knowledge
Time Frame
Up to 24 months
Title
Provider's decision making
Description
Proportion of correct responses: Clinical vignettes representing common clinical scenario of glucose management in the hospital
Time Frame
Up to 24 months
Title
Provider's practice performance
Description
Number of insulin treatment adjustments.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kalen Coordinator, MS
Phone
7175310003
Ext
281452
Email
kkearcher@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariana Pichardo-Lowden, MD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalen Coordinator, MS
Phone
717-531-0003
Email
kkearcher@pennstatehealth.psu.edu
Facility Name
Penn State Health St. Joseph Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franciss Quigley, MD
Phone
610-378-2440
Email
fquigley@pennstatehealth.psu.edu

12. IPD Sharing Statement

Learn more about this trial

Diabetes Clinical Decision Support

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