An interventional study of Discharge Order Set (DOS) and Enhanced Standard Care (ESC) in Diabetes Mellitus, Type 2, Patient Discharge and Blood Glucose, Low, sponsored by Ohio State University. Terminated at 1 site in United States. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
In this 24 week randomized controlled trial, hospitalized insulin-requiring patients with type 2 diabetes and poor glycemic control (HbA1c >8.5%) will receive standard of care insulin therapy including basal insulin glargine U300 (TOUJEO®) plus additional background therapy (non-insulin and prandial insulin therapies) with either a diabetes focused discharge order set (DOS) and follow-up communication to facilitate insulin titration and outpatient follow-up or enhanced standard care (ESC). 222 patients (type 2 diabetes) will be recruited. Hospitalized patients with type 2 diabetes (HbA1c >8.5%) who are receiving basal insulin at least 10 unit per day and are able to provide informed consent and complete study procedures will be approached. All patients will be discharged on glargine U300 with initial doses determined by the discharging team. Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Patients will have follow-up phone calls at week 2, 6, and in-person visits at week 12 and 24. Phone calls will assess adherence with instructions for self-titration in the DOS group but are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. The study and all study-related documents will be approved by the OSU IRB. All data analyses will be completed as intention to treat analyses. Longitudinal outcomes (e.g., HbA1c) will be analyzed using mixed models utilizing all available measurements from individuals randomized.
Exclusion Criteria:
Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider.
Other: Discharge Order Set (DOS)
Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
Other: Enhanced Standard Care (ESC)
In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.
Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
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.
Time frame: 24 weeks
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.
Time frame: 12 weeks
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.
Time frame: 24 weeks
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.
Time frame: 24 weeks
| Milestone | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) |
|---|---|---|
| Started | 82 | 76 |
| Completed | 44 | 45 |
| Not completed | 38 | 31 |
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.
| percentage of glycosylated hemoglobin | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) |
|---|---|---|
| Change in HbA1c From Baseline to 24 Weeks | -2.1 ± 0.3 | -1.0 ± 0.3 |
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.
| percentage of glycosylated hemoglobin | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) |
|---|---|---|
| Change in HbA1c From Baseline to 12 Weeks | -2.0 ± 0.3 | -1.4 ± 0.3 |
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.
| Participants | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) |
|---|---|---|
| Proportion Using Insulin Glargine U300 at 24 Weeks | 25 | 25 |
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.
| mg/dl | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) |
|---|---|---|
| Fasting Glucose | 152.5 (127.3 to 247.3) | 209 (129.5 to 234) |
Collected over 24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Discharge Order Set (DOS) | 1/82 (1.2%) | 30/82 (36.6%) | 0/82 (0%) |
| Enhanced Standard Care (ESC) | 0/76 (0%) | 34/76 (44.7%) | 0/76 (0%) |
| Event | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) |
|---|---|---|
| Severe hypoglycemiaEndocrine disorders | 5/82 | 8/76 |
| heart failureCardiac disorders | 2/82 | 5/76 |
| HyperglycemiaEndocrine disorders | 3/82 | 2/76 |
| Acute kidney injuryRenal and urinary disorders | 2/82 | 2/76 |
| chest painCardiac disorders | 0/82 | 2/76 |
| cerebrovascular accidentNervous system disorders | 0/82 | 2/76 |
| Diabetic ketoacidosisEndocrine disorders | 2/82 | 0/76 |
| Lumbar degenerative disc diseaseMusculoskeletal and connective tissue disorders | 2/82 | 0/76 |
| foot ulcerSkin and subcutaneous tissue disorders | 2/82 | 1/76 |
| Transient Ischemic AttackNervous system disorders | 1/82 | 1/76 |
Analysis population is the same as the participant flow.
| Age, Categorical(Participants) | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 72 | 67 | 139 |
| >=65 years | 10 | 9 | 19 |
| Age, Continuous(years) | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) | Total |
|---|---|---|---|
| Mean | 52.0 ± 10.1 | 51.4 ± 10.5 | 51.7 ± 10.2 |
| Sex: Female, Male(Participants) | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) | Total |
|---|---|---|---|
| Female | 47 | 43 | 90 |
| Male | 35 | 33 | 68 |
| Ethnicity (NIH/OMB)(Participants) | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 80 | 75 | 155 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 41 | 41 | 82 |
| White | 40 | 34 | 74 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Discharge Order Set (DOS) | Enhanced Standard Care (ESC) | Total |
|---|---|---|---|
| United States | 82 | 76 | 158 |
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Ohio State University