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 tests a new tool called the DM Discharge Toolkit, designed to assist individuals leaving the hospital who need to start using insulin. The researchers aim to determine if this tool can enhance diabetes management after discharge. Participants will either use the new toolkit or continue with the standard hospital education about insulin. Ideal candidates speak English, have recently been advised to start insulin, and are preparing to leave the hospital. As an unphased trial, this study allows participants to contribute to innovative diabetes care solutions.

Will I have to stop taking my current medications?

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

What prior data suggests that the DM Discharge Toolkit is safe for patients newly requiring insulin?

Research has shown that the Diabetes Discharge Toolkit aids individuals in managing their diabetes more effectively after hospital discharge. The toolkit enhances education and monitoring, benefiting those new to insulin use. While specific safety data for the toolkit is lacking, it is generally considered low-risk due to its focus on education and support. Notably, it does not introduce new drugs or medical procedures, eliminating concerns about medication-related side effects. The toolkit aims to provide better information and support, which typically carries no safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Discharge Toolkit because it aims to enhance patient education beyond the current standard of care for diabetes management. Unlike traditional discharge education that focuses solely on insulin use, this toolkit provides additional resources and guidance to support patients as they transition from hospital to home. By offering more comprehensive education, the toolkit has the potential to improve patient understanding and management of their condition, leading to better health outcomes.

What evidence suggests that the DM Discharge Toolkit is effective for diabetes?

Research shows that the Diabetes Discharge Toolkit, which participants in this trial may receive, focuses on teaching and empowering patients to manage their diabetes better. Studies have found that similar programs using electronic discharge instructions and follow-up calls help patients stick to their treatment plans after leaving the hospital. Other research indicates that education from diabetes specialists can reduce the chances of hospital readmission. These findings suggest that the Diabetes Discharge Toolkit, tested in this trial, could help newly diagnosed patients who need insulin manage their condition more effectively. ^{2 3 4 6 7}

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

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-diabetes-mellitus-11-2022-37038

Diabetes Discharge Toolkit for Diabetes The Diabetes Discharge Toolkit is unique because it focuses on providing education and empowerment strategies to help patients manage their diabetes effectively ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9364166/

Effectiveness of a Diabetes-Focused Electronic Discharge ... In this study, we assessed whether an electronic discharge order set (DOS) plus nurse follow-up calls improve discharge orders and postdischarge outcomes.

3. diabetesjournals.org diabetesjournals.org/spectrum/article/35/4/440/147870/Instituting-a-Successful-Discharge-Plan-for

Instituting a Successful Discharge Plan for Patients With Type ... This article presents an algorithm to assist clinicians in selecting discharge regimens that maximize benefits and reduce barriers to self-care ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214623717300212

The effect of diabetes case management and ... The Diabetes Resource Nurse program is effective in decreasing readmission rates. Patients seen by the diabetes educators have the lowest rates of readmission.

5. clinicaltrial.be clinicaltrial.be/en/details/190552?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Diabetes Toolkit at Discharge This study is a randomized controlled trial with a parallel group design of up to 120 study participants in a 1:1 ratio to receive either ...

6. reporter.nih.gov reporter.nih.gov/project-details/10748295

Project Details - NIH RePORTER This research focuses on adapting, integrating, implementing, and testing, through a clinical trial, a telehealth diabetes discharge toolkit.

7. diabetes.jmir.org diabetes.jmir.org/2022/3/e33401/

Effectiveness of a Diabetes-Focused Electronic Discharge ... The primary outcome was change in glycated hemoglobin (HbA1c) level at 24 weeks after discharge.