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NCT03455985 · ClinicalTrials.gov registry record · NA
Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin
A NA study, sponsored by Ohio State University.
- Terminated
- Registry status
- NA
- Development phase
- 158
- Enrollment target
NCT03455985: Clinical Trial NA study, sponsored by Ohio State University.
NCT03455985 is a NA study that was terminated before completion, run by Ohio State University. The registered enrollment target is 158 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03455985, a NA study, was terminated before completion, sponsored by Ohio State University.
- TERMINATED
- Registry status
- NA
- Development phase
- 158 participants
- Enrollment target
Study Summary
Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge programs for patients with diabetes are understudied. In particular, patients who are initiating or intensifying insulin therapy have the most to benefit in terms of glycemic control. However, these patients are also particularly vulnerable to poor transitions of care for a variety of reasons, including the complexity of therapy, inadequate patient education, differences in patient and provider expectations, and insufficient resources. Disruption of insulin therapy following hospitalization is associated with higher HbA1c, shorter survival, and increased readmissions and medical costs. In a Society of Hospital Medicine Survey, only one fourth of hospitals were supported with written protocols to standardize medication, education, equipment, and follow-up instructions. However, discharge order sets have largely been limited to the inpatient setting and have not been utilized to guide insulin use at hospital discharge. This study will assess whether a nurse supported diabetes focused inpatient discharge order set (DOS) can improve post-discharge outcomes among hospitalized patients with poorly controlled insulin-requiring diabetes.
Primary Outcome
We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 24 weeks change in Hb1Ac.
Interventions
- OTHER Discharge Order Set (DOS)
- OTHER Enhanced Standard Care (ESC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2020-09-11 |
| Phase | NA |
Why NCT03455985 stopped before completion
NCT03455985 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Discharge Order Set (DOS) is the first listed.
NCT03455985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03455985 about?
NCT03455985 is a clinical study titled "Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin". Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge programs for patients with diabetes are understudied. In particular, patients who are initiating or intensifying insulin therapy have the most to benefit in terms of glycemic control. However, these patients are al...
What is the current status of trial NCT03455985?
This trial is currently terminated. It is a NA study. The enrollment target is 158 participants. The study started on 2018-05-01. Estimated completion is 2020-09-11.
What interventions are being tested in trial NCT03455985?
The interventions under investigation include: Discharge Order Set (DOS) (OTHER), Enhanced Standard Care (ESC) (OTHER).
Who is sponsoring clinical trial NCT03455985?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03455985's enrollment target sits among peer trials
158 654th of 2000 higher than 1,345 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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