Diabetes, Hyperglycemia, Hyperglycemia Stress, Hypoglycemia, PreDiabetes
Conditions
Keywords
Clinical Decision Support, Electronic Medical Records, Health Systems Science, Hospital Management
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 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.
Interventions
DEVICEActive 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.
Sponsors
Milton S. Hershey Medical Center
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes 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.
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 four community hospitals. The tool will be intermittently active in the EMR hospital-wide every 3 months for 36-months to enable an intervention (active) and a control (inactive) group of 18 months each in each hospital.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average hospital length of stay (LOS) | Duration of hospital admission, up to 3 months | Number of days in the hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of gap in care events | 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 \[sliding scale monotherapy any time\]. |
| Glycemic control parameters - Glucose metrics | Duration of hospital admission, up to 3 months | Average glucose per admission, glucose range (Glucose value in mg/dl) |
| Glycemic control parameters - average glucose per day per admission | 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). |
| Glycemic control parameters - glycemic variability | Duration of hospital admission, up to 3 months | Standard deviation |
| Incidence of inpatient mortality | Duration of hospital admission, up to 3 months | Number of deceased patients |
| Incidence of post-discharge mortality | Up to 3 months after discharge | Number of deceased patients |
| Proportion of hospital-acquired infections | 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 |
| Proportion of surgical complications | 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 |
| Proportion of medical complications | 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. |
| Proportion of safety events | 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 |
| Frequency of severity of illness | Duration of hospital admission, up to 3 months | 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 | 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). |
| Average reduction of glycohemoglobin level within 12 months of discharge | 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 |
| Frequency of hospital readmission | Up to 30 days after being discharged from the hospital | Number of admissions: Admission within 7, 14, and 30 days from discharge. |
| Frequency of Intensive Care unit (ICU) transfers | Duration of hospital admission, up to 3 months | Number of transfers: Refers to admission to ICU transferred from non-ICU units |
| Cost of hospitalization | Duration of hospital admission, up to 3 months | Log-transformed amount of hospital submitted claims |
| Frequency of post-hospitalization skilled care needed from home to more advanced care | 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. |
| Frequency of post-hospitalization skilled care needed | 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. |
| Frequency of utilization of consulting services resource | Duration of hospital admission, up to 3 months | Number of consults to diabetes services (endocrinology, diabetes education, hospitalists). |
| Hospital revenue | Duration of hospital admission, up to 3 months | Number in category of DRG for expected reimbursement |
Countries
United States
Contacts
CONTACTAriana Pichardo-Lowden, MD
PRINCIPAL_INVESTIGATORAriana Pichardo-Lowden, MD
Penn State College of Medicine
Outcome results
None listed