DiabetesNCT02230488
Intensive Case Diabetes Management (ICDM) to Prevent Readmission
A study testing Intensive Diabetes Case Management in people with Diabetes, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to assess whether intensive case management interventions by a diabetes team, led by an endocrinologist and certified diabetes educator, can prevent <31 day readmission in previously identified high risk patients with diabetes.The procedures of the study will focus on managing the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Intensive Diabetes Case Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted with a diagnosis of diabetes, Patients with a previous history of Pharmacy Expert System (PES) alert, Enrollment in research must be within 24 hours of admission
Who cannot join
- Patients transferred from institutionalized care, Patients who already plan to move to institutionalized care, Patients with severe co-morbidities (e.g. terminal cancer), Patients admitted for surgery within 24 hours, Patients who are unwilling or unable to give written consent (e.g. dementia), Patients who are homeless, Patients previously admitted to the diabetes endocrine service
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Case Diabetes Management to Prevent Readmission of Previously Identified High Risk Patients
The purpose of this study is to assess whether intensive case management interventions by a diabetes team, led by an endocrinologist and certified diabetes educator, can prevent <31 day readmission in previously identified high risk patients with diabetes.The procedures of the study will focus on managing the patient's diabetes and diabetes education while in the hospital, decreasing the patient's risk for hypoglycemia and hyperglycemia in the hospital, and assist in the patient's diabetes management plan for a safe discharge.
- Conditions
- Diabetes
- Being tested
- Intensive Diabetes Case Management
- Keywords
- Inpatient Diabetes Management, Prevent <31 day readmission in patients with Diabetes, CDEs role in transition of care of inpatients with diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Diabetes Case ManagementOther
A diabetes team , led by an endocrinologist and CDE, will manage the patients diabetes while in the hospital and will assist with the patient's discharge Diabetes endocrine consult team will manage the patient's diabetes daily while in the hospital Discharge diabetes medication reconciliation per research team Research team will provide 30 day supply of diabetes medication/supplies at discharge Research Team will provide 30 day supply of glucose test strips at discharge Discharge telecommunication from endocrinologist to primary care provider Patient-centered discharge diabetes education per research CDE Post-discharge 48-72 hours continuity check per phone by a diabetes research team member/CDE
--------------------------------------------------------------------------------
| Study group | Role | What they receive |
|---|---|---|
| Intensive Diabetes Case Management | Active comparator | Intensive Case Diabetes Management : A diabetes team , led by an endocrinologist and CDE, will manage the patients diabetes while in the hospital and will assist with the patient's discharge Diabetes endocrine consult team will manage the patient's diabetes daily while in the hospital Discharge diabetes medication reconciliation per research team Research team will provide 30 day supply of diabetes medication/supplies at discharge Research Team will provide 30 day supply of glucose test strips at discharge Discharge telecommunication from endocrinologist to primary care provider Patient-centered discharge diabetes education per research CDE Post-discharge 48-72 hours continuity check per phone by a diabetes research team member/CDE Receives: Other: Intensive Diabetes Case Management |
| Control :Standard/ usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevent <31 day readmission
Primary outcome measure is to assess whether an intensive case management intervention by a diabetes team, led by an endocrinologist and a certified diabetes educator (CDE) , can prevent a <31 day readmission in previously identified high risk patients with diabetes compared to standard/usual care.
Measured: The length of time between hospital discharge and readmission 31 days
Secondary outcomes (1)
improve overall glycemic management
To examine whether intensive case management intervention per endocrinologist and CDE during hospital stay prevents hypoglycemia <70mg/dl, severe hypoglycemia <40mg/dl, and improves overall glycemic management (100-180 mg/dl) compared to standard/usual care.
Measured: Upon the participant's consent (within 24 hours of hospital admission) to hospital discharge- the average length of stay is five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Unable to enroll due to protocol exclusion criteria and participant population pool
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Garry Tobin, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230488
- Sponsor's protocol ID
- 201405143
- Status last verified
- Jun 2015
- First submitted
- 26 Aug 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Case Diabetes Management to Prevent Readmission of Previously Identified High Risk Patients
- ClinicalTrials.gov ID
- NCT02230488
- Acronym / sponsor ID
- 201405143
- Conditions
- Diabetes
- Keywords
- Inpatient Diabetes Management, Prevent <31 day readmission in patients with Diabetes, CDEs role in transition of care of inpatients with diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll due to protocol exclusion criteria and participant population pool
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Sep 2014 (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 purpose of this study is to assess whether intensive case management interventions by a diabetes team, led by an endocrinologist and certified diabetes educator, can prevent <31 day readmission in previously identified high risk patients with diabetes.The procedures of the study will focus on managing the patient's diabetes and diabetes education while in the hospital, decreasing the patient's risk for hypoglycemia and hyperglycemia in the hospital, and assist in the patient's diabetes management plan for a safe discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Diabetes Case Management | Active comparator | Other: Intensive Diabetes Case ManagementIntensive Case Diabetes Management : A diabetes team , led by an endocrinologist and CDE, will manage the patients diabetes while in the hospital and will assist with the patient's discharge Diabetes endocrine consult team will manage the patient's diabetes daily while in the hospital Discharge diabetes medication reconciliation per research team Research team will provide 30 day supply of diabetes medication/supplies at discharge Research Team will provide 30 day supply of glucose test strips at discharge Discharge telecommunication from endocrinologist to primary care provider Patient-centered discharge diabetes education per research CDE Post-discharge 48-72 hours continuity check per phone by a diabetes research team member/CDE |
| Control :Standard/ usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted with a diagnosis of diabetes, Patients with a previous history of Pharmacy Expert System (PES) alert, Enrollment in research must be within 24 hours of admission
Key exclusion criteria (1 listed)
- Patients transferred from institutionalized care, Patients who already plan to move to institutionalized care, Patients with severe co-morbidities (e.g. terminal cancer), Patients admitted for surgery within 24 hours, Patients who are unwilling or unable to give written consent (e.g. dementia), Patients who are homeless, Patients previously admitted to the diabetes endocrine service
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 |
|---|---|---|
| Intensive Diabetes Case ManagementA diabetes team , led by an endocrinologist and CDE, will manage the patients diabetes while in the hospital and will assist with the patient's discharge Diabetes endocrine consult team will manage the patient's diabetes daily while in the hospital Discharge diabetes medication reconciliation per research team Research team will provide 30 day supply of diabetes medication/supplies at discharge Research Team will provide 30 day supply of glucose test strips at discharge Discharge telecommunication from endocrinologist to primary care provider Patient-centered discharge diabetes education per research CDE Post-discharge 48-72 hours continuity check per phone by a diabetes research team member/CDE -------------------------------------------------------------------------------- | Other | Intensive Diabetes Case Management |
Primary outcome
Prevent <31 day readmission
Time frame: The length of time between hospital discharge and readmission 31 days
Primary outcome measure is to assess whether an intensive case management intervention by a diabetes team, led by an endocrinologist and a certified diabetes educator (CDE) , can prevent a <31 day readmission in previously identified high risk patients with diabetes compared to standard/usual care.
1 secondary outcome
improve overall glycemic management
Time frame: Upon the participant's consent (within 24 hours of hospital admission) to hospital discharge- the average length of stay is five days
Results and safety
The study was stopped early (reason given: Unable to enroll due to protocol exclusion criteria and participant population pool). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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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.
Garry Tobin, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Diabetes Case Management in people with Diabetes, run by Washington University School of Medicine at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Unable to enroll due to protocol exclusion criteria and participant population pool). Results are not available in the source record.
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?
Prevent <31 day readmission (time frame: The length of time between hospital discharge and readmission 31 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2015.