Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 25 - 75 |
| Updated: | 8/24/2018 |
| Start Date: | May 1, 2018 |
| End Date: | April 30, 2020 |
| Contact: | Jacob E LaFleur, BA |
| Email: | jacob.lafleur@osumc.edu |
| Phone: | 6146886262 |
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.
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.
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.
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
We found this trial at
1
site
281 W. Lane Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Kathleen Dungan, M.D.
Phone: 614-688-6262
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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