← Back to Search

Advance Care Planning for Type 2 Diabetes

N/A

Waitlist Available

Led By Richard W Grant, MD MPH

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 75 years

Type 2 diabetes with last measured HbA1c ≤ 8.0%

Must not have

Unable to communicate in English

Unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 - 12 months following the first study-related visit

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether expanded advance care planning can help older adults with type 2 diabetes make treatment decisions that are aligned with their values, and whether this can reduce the incidence of hypoglycemia.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves education and planning rather than medication, direct side effects are not expected. However, changes in diabetes management as a result could lead to adjustments in blood sugar levels that need monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 75 years old or older.

Select...

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

Select...

I am currently taking insulin or sulfonylureas for my diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot communicate in English.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 - 12 months following the first study-related visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 - 12 months following the first study-related visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 - 12 months following the first study-related visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Any incidence of hypoglycemia

Secondary study objectives

Clinical Utilization Outcome: Hypoglycemic-related admissions to Emergency Department or Hospital

Medication-Related Outcome: Aggregate measure of diabetes medication deprescribing

Patient-Centered Outcome: Active Patient Participation during primary care visits

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Educational Video and Action Plan handoutExperimental Treatment1 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 CareActive Control1 Intervention

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

0 / 5Eligibility criteria met