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

NCT03455985 | Terminated Results

• 1 other identifier: 2017H0354
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in HbA1c From Baseline to 12 Weeks

  12 weeks

• Proportion Using Insulin Glargine U300 at 24 Weeks

  24 weeks

• Fasting Glucose

  24 weeks

Study Arms (2)

Discharge Order Set (DOS)

EXPERIMENTAL

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)

Enhanced Standard Care (ESC)

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.

Other: Enhanced Standard Care (ESC)

Interventions

Discharge Order Set (DOS) 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.

Discharge Order Set (DOS)

Enhanced Standard Care (ESC) 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.

Enhanced Standard Care (ESC)

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Sensitive admissions: Prisoners
• Pregnancy
• Unable to consent or follow study directions in English
• Expected nursing facility stay longer than 2 weeks

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (56)

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  PMID: 35958875 DERIVED

• White A, Bradley D, Buschur E, Harris C, LaFleur J, Pennell M, Soliman A, Wyne K, Dungan K. Effectiveness of a Diabetes-Focused Electronic Discharge Order Set and Postdischarge Nursing Support Among Poorly Controlled Hospitalized Patients: Randomized Controlled Trial. JMIR Diabetes. 2022 Jul 26;7(3):e33401. doi: 10.2196/33401.

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Related Links

• Healthcare Cost and Utilization Project. Economic and Health Costs of Diabetes
• Toujeo prescribing instructions

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The study was stopped early due to loss to follow-up.

Results Point of Contact

• Title: Kathleen Dungan
• Organization: The Ohio State University

kathleen.dungan@osumc.edu

6146853333

Study Officials

• Kathleen Dungan, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 7, 2018
• Study Start: May 1, 2018
• Primary Completion: September 11, 2020
• Study Completion: September 11, 2020
• Last Updated: February 22, 2024
• Results First Posted: February 22, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)