Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin
Condition: Diabetes Mellitus, Type 2; Patient Discharge; Blood Glucose, Low; Blood Glucose, High
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Discharge Order Set (DOS); Enhanced Standard Care (ESC)
Intervention type(s): Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment