Diabetes Clinical Decision Support
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Children (<18 years)
Trial design
Design model
Parallel
Treatments tested in this trial
Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support
DeviceThis 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.
Treatment groups
15,732 Participants
are divided into 2 treatment groupsGroup A: Active Inpatient Diabetes Clinical Decision SupportExperimental treatment 1 intervention
Group B: Inactive Inpatient Diabetes Clinical Decision SupportNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Average hospital length of stay (LOS)
Number of days in the hospital
Time frame
Duration of hospital admission, up to 3 monthsSecondary outcomes
1
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 \[sliding scale monotherapy any time\].
Time frame
Duration of hospital admission, up to 3 months2
Glycemic control parameters - Glucose metrics
Average glucose per admission, glucose range (Glucose value in mg/dl)
Time frame
Duration of hospital admission, up to 3 months3
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).
Time frame
Duration of hospital admission, up to 3 months4
Glycemic control parameters - glycemic variability
Standard deviation
Time frame
Duration of hospital admission, up to 3 monthsOther outcomes
1
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).
Time frame
Up to 48 months2
Provider's knowledge
Multiple choice questions correct responses: Refers to question on contextual and biomedical knowledge
Time frame
Up to 48 months3
Provider's decision making
Proportion of correct responses: Clinical vignettes representing common clinical scenario of glucose management in the hospital
Time frame
Up to 48 months4
Provider's practice performance
Number of insulin treatment adjustments.
Time frame
Up to 48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov