Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin

NCT ID: NCT03455985

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2020-09-11

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Patient Discharge; Blood Glucose, Low; Blood Glucose, High

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Discharge Order Set (DOS)

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.

Group Type: EXPERIMENTAL

Discharge Order Set (DOS)

Intervention Type: OTHER

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.

Enhanced Standard Care (ESC)

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.

Group Type: OTHER

Enhanced Standard Care (ESC)

Intervention Type: OTHER

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.

Interventions

Discharge Order Set (DOS)

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.

Intervention Type: OTHER

Enhanced Standard Care (ESC)

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Dungan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Dungan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://archive.ahrq.gov/data/hcup/highlight1/high1.pdf

Healthcare Cost and Utilization Project. Economic and Health Costs of Diabetes

http://products.sanofi.us/toujeo/toujeo.pdf

Toujeo prescribing instructions

Other Identifiers

2017H0354

Identifier Type: -

Identifier Source: org_study_id