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

600 Participants Needed

Trial Summary

What is the purpose of this trial?

As adults with type 2 diabetes age, they are increasingly vulnerable to treatment-related hypoglycemia and its related complications (including hospitalization and death). This study proposes to evaluate, in a randomized clinical trial, a strategy of expanded advance care planning to support older adults in value-aligned re-assessment of diabetes treatment regimens with their primary care team. If the aims of this project are achieved and incidence of clinically-significant hypoglycemia is reduced, this Prepare for Your Diabetes web-based patient educational care strategy could be scaled and applied in a wide variety of healthcare settings and chronic conditions in which evolving risks, benefits, and consequences of treatment require re-assessment with age.

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 data supports the effectiveness of the treatment Prepare for Your Diabetes Care for Type 2 Diabetes?

Research suggests that having a diabetes advance directive, which is a plan for managing diabetes in different situations, can improve outcomes for people with diabetes by allowing them to continue their self-management even in hospitals. This approach can help maintain effective diabetes management and improve both clinical and patient-reported outcomes. ^{1 2 3 4 5}

Is the Advance Care Planning for Type 2 Diabetes treatment safe for humans?

The research articles do not provide specific safety data for the Advance Care Planning for Type 2 Diabetes treatment or its other names. They focus on risk assessment, medication management, and quality control in diabetes care, but do not address the safety of this specific treatment. ^{6 7 8 9 10}

How is the 'Prepare for Your Diabetes Care' treatment different from usual care for Type 2 Diabetes?

The 'Prepare for Your Diabetes Care' treatment is unique because it focuses on advance care planning (ACP), which involves preparing patients for future medical decisions, especially when they might not be able to make those decisions themselves. This approach is integrated into routine care and emphasizes structured discussions and documentation of patient preferences, which is not typically a focus in standard diabetes care. ^{11 12 13 14 15}

Research Team

Richard W Grant, MD MPH

Principal Investigator

Kaiser Permanente Northern California - Division of Research

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

The Need for Diabetes Advance Directives to Support the Care of People With Diabetes. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes: a challenge for patient and physician. [2019]

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

Association between person and disease related factors and the planned diabetes care in people who receive person-centered type 2 diabetes care: An implementation study. [2020]

4. Spain pubmed.ncbi.nlm.nih.gov

A comparison of clinical pharmacist management of type 2 diabetes versus usual care in a federally qualified health center. [2022]

5. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

[Decision Cycle for Patient-Centered Glycemic Management in Type 2 Diabetes]. [2020]

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

Approaches to Risk Assessment Among Older Patients With Diabetes. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Structured primary care for type 2 diabetes has positive effects on clinical outcomes. [2022]

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

Quality Control Measures over 30 Years in a Multicenter Clinical Study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study. [2018]

9. Australia pubmed.ncbi.nlm.nih.gov

Medication management of type 2 diabetes in residential aged care [2022]

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

Unintentional therapeutic errors involving insulin in the ambulatory setting reported to poison centers. [2011]

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

Preparing Older Patients With Serious Illness for Advance Care Planning Discussions in Primary Care. [2020]

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

Improving Advance Care Planning Documentation Using Reminders to Patients and Physicians: A Longitudinal Study in Primary Care. [2022]

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

Advance care planning. [2019]

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

Use of an Ambulatory Patient Portal for Advance Care Planning Engagement. [2021]

15. United States 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. [2023]