Diabetes Discharge Toolkit for Diabetes

Overseen By Christina Coventry, MSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must be taking: Insulin

Disqualifiers: Non-English, No diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: Immediate post-discharge

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new set of tools called the DM Discharge Toolkit to help patients who are new to using insulin manage their diabetes after leaving the hospital. The toolkit includes educational materials and practical resources to make it easier for these patients to take care of themselves at home.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Diabetes Discharge Toolkit safe for humans?

The available research does not provide specific safety data for the Diabetes Discharge Toolkit, but it highlights the importance of monitoring and education to prevent adverse events in diabetes care. General safety concerns in diabetes management include potential adverse effects from medications and the need for proper education to ensure safe transitions from hospital to home. ^{1 2 3 4 5}

What makes the Diabetes Discharge Toolkit treatment unique for diabetes management?

The Diabetes Discharge Toolkit is unique because it focuses on providing education and empowerment strategies to help patients manage their diabetes effectively after leaving the hospital. Unlike traditional treatments that may focus solely on medication, this toolkit emphasizes patient education and support, potentially involving family members or friends to improve self-management and reduce complications. ^{6 7 8 9 10}

What data supports the effectiveness of the DM Discharge Toolkit treatment for diabetes?

Research suggests that structured discharge planning, which is a key component of the DM Discharge Toolkit, plays a crucial role in helping patients manage their diabetes at home and avoid hospital readmissions. Effective discharge planning includes empowering patients with self-care strategies and providing guidance to maintain good blood sugar control. ^{7 11 12 13 14}

Who Is on the Research Team?

Amisha Wallia, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have recently been prescribed insulin at hospital discharge, expected to live more than 90 days, and speak English. It's not suitable for those without a new insulin prescription, without a diabetes diagnosis, non-English speakers, or anyone unable to consent.

Inclusion Criteria

I need to start insulin when I leave the hospital.

You are expected to live for more than 90 days.

Exclusion Criteria

I have not started taking insulin recently.

Non-English speaking

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the standard of care discharge DM training or the DM Discharge Toolkit intervention

Immediate post-discharge

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after discharge, including glucose levels and diabetes distress

90 days

Multiple assessments at 14, 30, and 90 days

What Are the Treatments Tested in This Trial?

Interventions

• DM Discharge Toolkit

Trial Overview The study is testing the 'DM Discharge Toolkit' designed to help patients manage their new insulin treatment after leaving the hospital. Participants are randomly chosen to receive this toolkit to see if it improves their care post-discharge.

How Is the Trial Designed?

Group I: DM Discharge Toolkit Experimental Treatment 1 Intervention

Up to 60 participants will be recruited for the intervention group. Participants will receive the current standard of care DM education for insulin at Northwestern Memorial Hospital and the adjunctive education with the DM Discharge Toolkit.

Group II: Current Standard of Care Discharge DM Training Active Control 1 Intervention

Up to 60 participants will be recruited for the control group. Participants will receive the current standard of care DM education for insulin use during current discharge care processes at Northwestern Memorial Hospital.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A systematic review of 11 studies involving 1073 participants found that individual empowerment strategies for diabetes management, such as consultations and educational materials, did not lead to significant reductions in HbA1c levels, which is a key measure of blood sugar control.

While these strategies did show some positive effects on psychosocial factors like self-efficacy and quality of life, the lack of impact on HbA1c suggests that these approaches need to be reevaluated to enhance their effectiveness in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of individual strategies for the empowerment of patients with diabetes mellitus: A systematic review with meta-analysis. Aquino, JA., Baldoni, NR., Flôr, CR., et al.[2022]

Educational interventions for healthcare professionals, including a 6-hour standardized course, significantly improved their attitudes and motivation towards monitoring diabetes, which is crucial for patient safety.

The study suggests that these interventions can enhance the control of diabetes in patients, as measured by HbA1c levels, although the specific outcomes on patient control were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. Cabré, JJ., Ripoll, M., Hernández, JM., et al.[2021]

Integrating web-based diabetes survival skills education (DSSE) into nursing workflows is seen as beneficial by healthcare staff, highlighting a strong interest in improving patient education for diabetes management during hospital discharge.

Key barriers to implementation include concerns about tablet usability, infection control, and workflow integration, indicating that adaptations are necessary to successfully deliver DSSE in inpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redesigning Hospital Diabetes Education: A Qualitative Evaluation With Nursing Teams. Smith, KM., Baker, KM., Bardsley, JK., et al.[2020]

A total of 684 adverse drug event reports related to insulin therapy and 84 reports for oral glucose-lowering agents were analyzed from care homes, highlighting a significant risk of harm for older residents with diabetes.

The most frequent errors involved incorrect or unclear dosing, with insulin errors leading to one reported death, indicating a critical need for improved medication management in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes medication patient safety incident reports to the National Reporting and Learning Service: the care home setting. Milligan, FJ., Krentz, AJ., Sinclair, AJ.[2016]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of individual strategies for the empowerment of patients with diabetes mellitus: A systematic review with meta-analysis. [2022]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Discharge Planning for People with Inpatient Hyperglycaemia: A Review on Pharmacological Management. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A performance score of the quality of inpatient diabetes care is a marker of clinical outcomes and suggests a cause-effect relationship between hypoglycaemia and the risk of in-hospital mortality. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Inpatient to outpatient transfer of diabetes care: planing for an effective hospital discharge. [2021]

5. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of a protocol designed to improve glycemic control in hospitalized internal medicine patients with hyperglycemia]. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing postdischarge adverse events: a neglected area. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Redesigning Hospital Diabetes Education: A Qualitative Evaluation With Nursing Teams. [2020]

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Diabetes medication patient safety incident reports to the National Reporting and Learning Service: the care home setting. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. [2022]

11. Brazil pubmed.ncbi.nlm.nih.gov

Analysis of the impact of a diabetes education program on glycemic control and prevalence of chronic complications. [2023]

12. England pubmed.ncbi.nlm.nih.gov

The Nurse Education and Transition (NEAT) model: educating the hospitalized patient with diabetes. [2020]

13. Switzerland pubmed.ncbi.nlm.nih.gov

A Self-Report Measure of Diabetes Self-Management for Type 1 and Type 2 Diabetes: The Diabetes Self-Management Questionnaire-Revised (DSMQ-R) - Clinimetric Evidence From Five Studies. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial. [2023]