Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin
Verified date | July 2023 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 158 |
Est. completion date | September 11, 2020 |
Est. primary completion date | September 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 75 Years |
Eligibility | Inclusion Criteria: - Diagnosis of diabetes, type 2 =3 months duration - HbA1c >8.5% - Ages 25-75 years - Phone or electronic media availability - Receiving basal insulin >10 unit/day Exclusion Criteria: - Sensitive admissions: Prisoners - Pregnancy - Unable to consent or follow study directions in English - Expected nursing facility stay longer than 2 weeks |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University |
United States,
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* Note: There are 54 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HbA1c From Baseline to 24 Weeks | 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. | 24 weeks | |
Secondary | Change in HbA1c From Baseline to 12 Weeks | 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 12 weeks change in Hb1Ac. | 12 weeks | |
Secondary | Proportion Using Insulin Glargine U300 at 24 Weeks | proportion of patients who remain on insulin glargine U300 at 24 weeks The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions. | 24 weeks | |
Secondary | Fasting Glucose | We will test for a difference in fasting glucose between the DOS and ESC groups using a linear mixed model.
reported measure differs from original plan due to lack of fasting glucose in hospitalized patients. |
24 weeks |
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