Diabetes MellitusNCT02847390
Implementation and Evaluation of an Inpatient Diabetes Superuser Education Program
An observational study of Diabetes Mellitus, run by Johns Hopkins University.
Trial summary
The investigators will develop a novel diabetes prescriber superuser educational program focused on inpatient diabetes management for physicians, based on their input. The investigators will then examine the impact of the diabetes prescriber superuser program and an analogous diabetes nurse superuser program that is… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Education intervention
- How many people
- 3,259 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (>18 years), non-obstetrical patients admitted to the medical services where housestaff and hospitalist superusers have been trained, with Type 1 diabetes, Type 2 diabetes, or individuals with hospital-related hyperglycemia who do not carry a prior diabetes diagnosis.
Who may be able to join
- Adult (>18 years)
- non-obstetrical patients admitted to the medical services where housestaff and hospitalist superusers have been trained with Type 1 diabetes or Type 2 diabetes
- individuals with hospital-related hyperglycemia who do not carry a prior diabetes diagnosis
Who cannot join
- Adults (>18 years) with diabetic ketoacidosis
- hyperosmolar coma
- diabetes with other coma.
About this study
The investigators will develop a novel diabetes prescriber superuser educational program focused on inpatient diabetes management for physicians, based on their input. The investigators will then examine the impact of the diabetes prescriber superuser program and an analogous diabetes nurse superuser program that is already developed on glycemic control and other outcomes in hospitalized patients with diabetes.
Read the detailed description
Both hyperglycemia and hypoglycemia in the hospital are associated with various adverse outcomes, including increased complications, length of stay, cost, and mortality. To address this issue, Johns Hopkins Hospital (JHH) established an Inpatient Glucose Management Program in 2006 to address hypoglycemia and hyperglycemia and to ensure safe, standardized care delivery for hospitalized patients with diabetes. To support nursing education and compliance with JHH glucose management policies, the diabetes nursing "superuser" program was initiated in January 2007 and was critical to implementing the hypoglycemia policy nursing interventions. Following the establishment of hospital-wide glucose management policies and order sets for hypoglycemia and hyperglycemia, the nursing diabetes "superuser" education program, and clinical decision support tools for prescribers, there was a significant and sustained reduction in the incidence of hypoglycemia (~20%) over a 3-year time period. However, the incidence of severe hyperglycemia was not significantly reduced by these interventions, indicating a differential impact of the program on hyperglycemia compared to hypoglycemia. The investigators believe this disparity is due to the hypoglycemia policy being implemented by the nursing staff, whereas the hyperglycemia policy and order set are implemented by prescribers (e.g., housestaff and hospitalists). Given the success of the investigators nursing program's in contributing to sustained reduction in hypoglycemia, the investigators hypothesize that an analogous diabetes prescriber superuser program, targeting physicians, will be an effective educational approach to addressing persistent hyperglycemia. The investigators proposal (1) it seeks to improve diabetes treatment in the hospital, a routine and relevant healthcare setting and (2) it utilizes existing healthcare infrastructure integrated into all hospitals-nursing staff and physicians-making it practical, scalable, and sustainable in other health systems. The investigators have the following specific aims: (1) to develop the diabetes prescriber superuser educational curriculum through Johns Hopkins Health System (JHHS) stakeholder community engagement; (2) to refine and package the JHH diabetes nursing and prescriber superuser educational curricula into an electronic tool kit and disseminate it locally to the 3 JHHS hospitals, based on stakeholder feedback; and (3) to evaluate the impact of implementing the JHH diabetes nursing and prescriber superuser programs at 3 JHHS hospitals on glycemic clinical outcome measures (primary). The investigators will secondarily assess the program's impact on glycemic process and economic measures.
- Conditions
- Diabetes Mellitus
- Being tested
- Education intervention
- Keywords
- diabetes mellitus, physician education, nursing education, hyperglycemia, hypoglycemia, inpatient, hospital, glycemic control
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education interventionOther
The investigators will develop and deliver a diabetes physician and nursing inpatient diabetes superuser educational curriculum focused on delivering safe, evidence-based diabetes care in the hospital setting. The physician educational curriculum will consist of 10 case-based modules taught to internal medicine residents at two academic hospitals and taught to hospitalists at two academic hospitals and one community hospital. The nursing educational curriculum will consistent of 12 case-based modules taught to unit-based nurses at two academic hospitals and one community hospital. These educational interventions will be delivered over a 6-month time frame from August 2016-April 2017.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation group | The investigators will develop and deliver a diabetes physician and nursing inpatient diabetes education intervention to our staff over a 6-month time frame from August 2016-January 2017. The investigators will use a before and after study design to assess the impact of the educational intervention on hospital-wide hypoglycemia and hyperglycemia. Adult (>18 years), non-obstetrical patients admitted to the medical services where housestaff and hospitalist superusers have been trained, with Type 1 diabetes, Type 2 diabetes, or individuals with hospital-related hyperglycemia who do not carry a prior diabetes diagnosis (4/1/16 to 6/30/16). | |
| Post-implementation group | Adult (>18 years), non-obstetrical patients admitted to the medical services where housestaff and hospitalist superusers have been trained, with Type 1 diabetes, Type 2 diabetes, or individuals with hospital-related hyperglycemia who do not carry a prior diabetes diagnosis (4/1/17 to 6/30/17). Receives: Other: Education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
Percentage and rate of patient-days with at least one hypoglycemic event during admission
Measured: Throughout 3 months post intervention
Hyperglycemia
Percentage of patient-days with patient-day weighted mean blood glucose in hyperglycemia range
Measured: Throughout 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startAug 2015
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherita Golden, M.D., M.H.S., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847390
- Sponsor's protocol ID
- IRB00071590
- Status last verified
- Aug 2019
- First submitted
- 25 Jul 2016
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Golden SH, Hager D, Gould LJ, Mathioudakis N, Pronovost PJ. A Gap Analysis Needs Assessment Tool to Drive a Care Delivery and Research Agenda for Integration of Care and Sharing of Best Practices Across a Health System. Jt Comm J Qual Patient Saf. 2017 Jan;43(1):18-28. doi: 10.1016/j.jcjq.2016.10.004. Epub 2016 Oct 13.
PubMed 28334581Mathioudakis N, Bashura H, Boyer L, Langan S, Padmanaban BS, Fayzullin S, Sokolinsky S, Hill Golden S. Development, Implementation, and Evaluation of a Physician-Targeted Inpatient Glycemic Management Curriculum. J Med Educ Curric Dev. 2019 Jul 15;6:2382120519861342. doi: 10.1177/2382120519861342. eCollection 2019 Jan-Dec.
PubMed 31321305
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of an Inpatient Diabetes Superuser Education Program
- ClinicalTrials.gov ID
- NCT02847390
- Acronym / sponsor ID
- IRB00071590
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, physician education, nursing education, hyperglycemia, hypoglycemia, inpatient, hospital, glycemic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,259 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will develop a novel diabetes prescriber superuser educational program focused on inpatient diabetes management for physicians, based on their input. The investigators will then examine the impact of the diabetes prescriber superuser program and an analogous diabetes nurse superuser program that is already developed on glycemic control and other outcomes in hospitalized patients with diabetes.
Detailed description
Both hyperglycemia and hypoglycemia in the hospital are associated with various adverse outcomes, including increased complications, length of stay, cost, and mortality. To address this issue, Johns Hopkins Hospital (JHH) established an Inpatient Glucose Management Program in 2006 to address hypoglycemia and hyperglycemia and to ensure safe, standardized care delivery for hospitalized patients with diabetes. To support nursing education and compliance with JHH glucose management policies, the diabetes nursing "superuser" program was initiated in January 2007 and was critical to implementing the hypoglycemia policy nursing interventions. Following the establishment of hospital-wide glucose management policies and order sets for hypoglycemia and hyperglycemia, the nursing diabetes "superuser" education program, and clinical decision support tools for prescribers, there was a significant and sustained reduction in the incidence of hypoglycemia (~20%) over a 3-year time period. However, the incidence of severe hyperglycemia was not significantly reduced by these interventions, indicating a differential impact of the program on hyperglycemia compared to hypoglycemia. The investigators believe this disparity is due to the hypoglycemia policy being implemented by the nursing staff, whereas the hyperglycemia policy and order set are implemented by prescribers (e.g., housestaff and hospitalists). Given the success of the investigators nursing program's in contributing to sustained reduction in hypoglycemia, the investigators hypothesize that an analogous diabetes prescriber superuser program, targeting physicians, will be an effective educational approach to addressing persistent hyperglycemia. The investigators proposal (1) it seeks to improve diabetes treatment in the hospital, a routine and relevant healthcare setting and (2) it utilizes existing healthcare infrastructure integrated into all hospitals-nursing staff and physicians-making it practical, scalable, and sustainable in other health systems. The investigators have the following specific aims: (1) to develop the diabetes prescriber superuser educational curriculum through Johns Hopkins Health System (JHHS) stakeholder community engagement; (2) to refine and package the JHH diabetes nursing and prescriber superuser educational curricula into an electronic tool kit and disseminate it locally to the 3 JHHS hospitals, based on stakeholder feedback; and (3) to evaluate the impact of implementing the JHH diabetes nursing and prescriber superuser programs at 3 JHHS hospitals on glycemic clinical outcome measures (primary). The investigators will secondarily assess the program's impact on glycemic process and economic measures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation group | – | –The investigators will develop and deliver a diabetes physician and nursing inpatient diabetes education intervention to our staff over a 6-month time frame from August 2016-January 2017. The investigators will use a before and after study design to assess the impact of the educational intervention on hospital-wide hypoglycemia and hyperglycemia. Adult (>18 years), non-obstetrical patients admitted to the medical services where housestaff and hospitalist superusers have been trained, with Type 1 diabetes, Type 2 diabetes, or individuals with hospital-related hyperglycemia who do not carry a prior diabetes diagnosis (4/1/16 to 6/30/16). |
| Post-implementation group | – | Other: Education interventionAdult (>18 years), non-obstetrical patients admitted to the medical services where housestaff and hospitalist superusers have been trained, with Type 1 diabetes, Type 2 diabetes, or individuals with hospital-related hyperglycemia who do not carry a prior diabetes diagnosis (4/1/17 to 6/30/17). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (>18 years), non-obstetrical patients admitted to the medical services where housestaff and hospitalist superusers have been trained, with Type 1 diabetes, Type 2 diabetes, or individuals with hospital-related hyperglycemia who do not carry a prior diabetes diagnosis.
Key inclusion criteria (3 listed)
- Adult (>18 years)
- non-obstetrical patients admitted to the medical services where housestaff and hospitalist superusers have been trained with Type 1 diabetes or Type 2 diabetes
- individuals with hospital-related hyperglycemia who do not carry a prior diabetes diagnosis
Key exclusion criteria (3 listed)
- Adults (>18 years) with diabetic ketoacidosis
- hyperosmolar coma
- diabetes with other coma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education interventionThe investigators will develop and deliver a diabetes physician and nursing inpatient diabetes superuser educational curriculum focused on delivering safe, evidence-based diabetes care in the hospital setting. The physician educational curriculum will consist of 10 case-based modules taught to internal medicine residents at two academic hospitals and taught to hospitalists at two academic hospitals and one community hospital. The nursing educational curriculum will consistent of 12 case-based modules taught to unit-based nurses at two academic hospitals and one community hospital. These educational interventions will be delivered over a 6-month time frame from August 2016-April 2017. | Other | Post-implementation group |
Primary outcome
Hypoglycemia
Time frame: Throughout 3 months post intervention
Percentage and rate of patient-days with at least one hypoglycemic event during admission
Hyperglycemia
Time frame: Throughout 3 months post intervention
Percentage of patient-days with patient-day weighted mean blood glucose in hyperglycemia range
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Background: PubMed 28334581Golden SH, Hager D, Gould LJ, Mathioudakis N, Pronovost PJ. A Gap Analysis Needs Assessment Tool to Drive a Care Delivery and Research Agenda for Integration of Care and Sharing of Best Practices Across a Health System. Jt Comm J Qual Patient Saf. 2017 Jan;43(1):18-28. doi: 10.1016/j.jcjq.2016.10.004. Epub 2016 Oct 13.
- Results publication: PubMed 31321305Mathioudakis N, Bashura H, Boyer L, Langan S, Padmanaban BS, Fayzullin S, Sokolinsky S, Hill Golden S. Development, Implementation, and Evaluation of a Physician-Targeted Inpatient Glycemic Management Curriculum. J Med Educ Curric Dev. 2019 Jul 15;6:2382120519861342. doi: 10.1177/2382120519861342. eCollection 2019 Jan-Dec.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherita Golden, M.D., M.H.S. principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia (time frame: Throughout 3 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02847390, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.