Advance Care Planning for Type 2 Diabetes

Overseen By Richard W Grant, MD MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must be taking: Insulin, SUs

Disqualifiers: Non-English, Cognitive deficits, others

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

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help older adults with type 2 diabetes manage their treatment plans as they age. It aims to reduce the risk of low blood sugar (hypoglycemia) by using an educational video and handout to facilitate discussions with doctors about treatment. Participants will either continue with their regular care (Usual Care) or try this new educational approach (Prepare for Your Diabetes Care). This study suits those who are 75 or older, have type 2 diabetes with well-managed blood sugar levels, and currently use insulin or certain diabetes medications. As an unphased trial, it offers participants the chance to contribute to innovative educational strategies that may enhance diabetes management for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves re-assessing diabetes treatment regimens, there might be changes based on discussions with your primary care team.

What prior data suggests that this strategy is safe for older adults with type 2 diabetes?

Research has shown that educational tools, such as the "Prepare for Your Diabetes Care" program, are generally safe for individuals. These programs use videos and handouts to enhance diabetes management. They educate patients on how treatment risks and benefits may change with age. Studies have not identified any harmful effects from using these educational videos or handouts for diabetes care.

Learning about diabetes is often crucial for effective management. This approach helps individuals understand their treatments and discuss necessary changes with their doctors. No evidence suggests that these educational tools cause harm; instead, they aim to improve understanding and communication about diabetes care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a personalized approach to managing Type 2 Diabetes. Unlike traditional methods that focus on medication and lifestyle changes, this approach uses an educational video along with an Action Plan handout to empower patients with knowledge about the evolving risks and benefits of diabetes treatments as they age. It actively involves patients in decision-making by eliciting their values and preferences, aiming to improve communication with their primary care providers. This method could lead to more tailored care and potentially better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that digital learning tools can assist people with type 2 diabetes. One study found that these programs improve blood sugar levels, overall health, and adherence to treatment plans. Another review found that online care, such as virtual education, leads to better health outcomes for people with diabetes. Videos created for diabetes education have helped with self-care and blood sugar control. In this trial, participants in the intervention arm will receive the "Prepare for Your Diabetes Care" program, which uses educational videos and action plans to potentially help older adults manage their diabetes more safely and effectively. ^{3 6 7 8 9}

Who Is on the Research Team?

Richard W Grant, MD MPH

Principal Investigator

Kaiser Permanente Northern California - Division of Research

Are You a Good Fit for This Trial?

This trial is for people aged 75 or older with Type 2 diabetes, who have an HbA1c level of 8.0% or less and are taking insulin or sulfonylureas (SUs). Participants must be Kaiser Permanente Northern California members, able to give informed consent, make decisions about their care, and communicate in English.

Inclusion Criteria

Kaiser Permanente Northern California member

I am 75 years old or older.

My last HbA1c level was 8.0% or lower and I have type 2 diabetes.

Exclusion Criteria

I cannot communicate in English.

I am unable to understand or communicate about my treatment due to cognitive issues.

Excluded by their primary care provider

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm view the Prepare for Your Diabetes Care web-based educational module and receive an Action Plan handout

12 months

Baseline, 6-month, and 12-month surveys

Control

Participants in the control arm continue with usual care and complete baseline, 6-month, and 12-month surveys

12 months

Baseline, 6-month, and 12-month surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Prepare for Your Diabetes Care
• Usual Care

Trial Overview The study is testing a web-based educational program called 'Prepare for Your Diabetes Care' against usual care. It aims to help older adults align their diabetes treatment with personal values by reassessing their treatment plans with healthcare teams to reduce the risk of low blood sugar complications.

How Is the Trial Designed?

Group I: Educational Video and Action Plan handout Experimental Treatment 1 Intervention

Patients in the intervention arm will be given access to an educational video (Prepare for Your Diabetes Care) and will be supported in viewing the video and the Action Plan handout. This program will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps with the participant's primary care provider.

Group II: Usual Care Active Control 1 Intervention

Patients in the control arm will continue with usual care and also complete baseline, 6-month, and 12-month surveys

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The SHARE intervention, designed for adults aged 80 and older with possible cognitive impairment and their care partners, aims to improve advance care planning (ACP) communication in primary care settings through a structured approach that includes trained facilitators and personalized agenda-setting.

This randomized controlled trial will assess the effectiveness of the SHARE intervention on the quality of end-of-life care communication at 6 months, highlighting the importance of addressing caregiver burden and clinician barriers in ACP discussions for individuals with cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sharing Health Care Wishes in Primary Care (SHARE) among older adults with possible cognitive impairment in primary care: Study protocol for a randomized controlled trial. Wolff, JL., Cagle, J., Echavarria, D., et al.[2023]

A significant increase in unintentional therapeutic errors involving insulin was observed over a 10-year period, with a 495% rise in annual incidence, particularly affecting adults over 40 years old and predominantly women.

Most of these errors occurred in non-healthcare settings, especially during late evening hours, highlighting the need for better management strategies and the importance of poison control centers as a resource for affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unintentional therapeutic errors involving insulin in the ambulatory setting reported to poison centers. Spiller, HA., Borys, DJ., Ryan, ML., et al.[2011]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12022518/

Efficacy of a Digital Educational Intervention for Patients With ... The digital educational intervention was effective at improving glycemic control, body composition, adherence, and patient satisfaction compared with usual ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11884068/

Effect of virtual care in type 2 diabetes management This umbrella review strengthens the evidence that virtual care significantly improves clinical outcomes in people with type 2 diabetes, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667276625000587

Impact of clinical pharmacist video-based education on self ... This study aimed to evaluate the impact of clinical pharmacist education on diabetes self-care and glycemic control in Sudanese adults with Type 2 Diabetes. 2.

4. youtube.com youtube.com/watch?v=FHfoDGWUAA4

A Case Study Approach to Type 2 Diabetes Care Our speakers will lead us through two case studies related to Diabetes Care and highlight important considerations for care.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/dmrr.3722

The use of videos for diabetes patient education: A ... This systematic review aims to synthesise the evidence for education videos for people with diabetes.

6. cdc.gov cdc.gov/diabetes/diabetes-tv/diabetes-kickstart.html

Diabetes Kickstart Video Series These 7 animated videos will show you the self-care steps you need to get started managing diabetes.

7. professional.diabetes.org professional.diabetes.org/clinical-support/patient-education-library

Diabetes Patient Education & Handouts | ADA Library Access a library of patient education materials. Download printable handouts, guides, and resources to support your patients in managing their diabetes.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10899831/

Telehealth Technologies in Diabetes Self-management ... This review focuses on self-educational telehealth tools available for diabetes self-management, their advantages and disadvantages, and factors that need to ...

9. adces.org adces.org/

Diabetes Care & Education Discover resources and education for diabetes care and education specialists and the care team to prevent and manage diabetes and related conditions.