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Trial record 4 of 4 for:    18308683 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03455985
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Kathleen Dungan, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Patient Discharge Blood Glucose, Low Blood Glucose, High Other: Discharge Order Set (DOS) Other: Enhanced Standard Care (ESC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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.

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.
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.




Primary Outcome Measures :
  1. Change in HbA1c at 24 weeks [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in HbA1c at 12 weeks [ Time Frame: 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.

  2. Persistence with insulin therapy. [ Time Frame: 24 weeks ]
    The difference in proportions between treatment groups will be computed and compared using test of proportions.

  3. Change in fasting glucose [ Time Frame: 24 weeks ]
    We will test for a difference in 24 week change in fasting glucose 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.



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455985


Contacts
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Contact: Adam Soliman, BA 6146886262 adam.soliman@osumc.edu
Contact: Angela Howell, LPN 6146883785 angela.howell@osumc.edu

Locations
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United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Adam Soliman, BA    614-688-6262    adam.soliman@osumc.edu   
Contact: Angela Howell, LPN    6146883785    angela.howell@osumc.edu   
Principal Investigator: Kathleen Dungan, M.D.         
Sub-Investigator: Elizabeth Buscher, M.D.         
Sub-Investigator: Cara Harris, NP         
Sub-Investigator: David Bradley, M.D.         
Sponsors and Collaborators
Ohio State University
Sanofi
Investigators
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Principal Investigator: Kathleen Dungan, M.D. Ohio State University
  Study Documents (Full-Text)

Documents provided by Kathleen Dungan, Ohio State University:
Informed Consent Form  [PDF] December 2, 2017


Additional Information:
Publications:

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Responsible Party: Kathleen Dungan, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03455985     History of Changes
Other Study ID Numbers: 2017H0354
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs