Prepare for Your Diabetes Care

Aging Clinical Trial

Official title:

Clinical Trial of Expanded Advance Care Planning to Address Regimen Intensity in Older Patients at High Risk for Treatment-Induced Hypoglycemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263310
• Other study ID #: IRB-1635322
• Secondary ID: R01AG068133
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: March 30, 2026

Study information

• Verified date: July 2023
• Source: Kaiser Permanente
• Contact: Ilana Peterson, MPH
• Phone: 877-220-3022
• Email: prepareresearchstudy[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In this pragmatic, clinical efficacy, parallel group randomized clinical trial, the study will enroll eligible Kaiser Permanente Northern California members (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas [SUs], and last measured HbA1c <=8%). Participants randomly allocated to the intervention arm will view the Prepare for Your Diabetes Care web-based educational module that is designed to help them prepare to discuss their diabetes medication regimens with their primary care providers and receive an Action Plan handout. Participants randomly allocated to the control arm will continue with usual care. All participants will complete baseline, 6-month, and 12-month surveys. The hypothesis is that empowering high-risk patients to engage in values-based discussions about diabetes treatment intensity will result - when clinically appropriate - in decreases in diabetes regimen intensity leading to decreased incidence of hypoglycemia over the 12-month study period. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Age = 75 years
• Type 2 diabetes with last measured HbA1c = 8.0%
• Currently prescribed insulin and/or SUs
• Kaiser Permanente Northern California member

Exclusion Criteria:

• Unable to communicate in English
• Unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits
• Excluded by their primary care provider

Related Conditions & MeSH terms

• Aging
• Diabetes Mellitus, Type 2
• Hypoglycemia
• Patient Activation
• Type 2 Diabetes Mellitus With Hypoglycemia

Intervention

Behavioral:
• Prepare for Your Diabetes Care
Educational video and Action Plan handout
• Usual Care
Control arm patients will continue with usual care

Locations

Country	Name	City	State
United States	Kaiser Permanente - Oakland Medical Center	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any incidence of hypoglycemia	Any one of the following hypoglycemia event measures: Self-report to survey question: Have you had three or more symptomatic hypoglycemia episodes in past 4 weeks (survey administered at month 6 and month 12); Self-report to survey question: Have you had one or more severe hypoglycemia episodes in past 6 months that resulted in passing out or needing active help from someone else (survey administered at month 6 and month 12); Clinical record of any emergency department or hospital admission with primary admitting diagnosis of hypoglycemia during the 12-month study period	12 months after baseline date
Secondary	Patient-Reported Outcome: Incidence of Severe Self-Reported Hypoglycemia	Patient report of any self-reported severe hypoglycemia episodes in past 6 months that resulted in passing out or needing active help from someone else	Preceding 6-month period (asked 6 and 12 months after first study-related visit)]
Secondary	Patient-Reported Outcome: Incidence of Symptomatic Self-Reported Hypoglycemia	Patient report of three or more self-reported symptomatic episodes in past 4 weeks (measured at 6- and 12-months)	Preceding 1-month period (asked 6 and 12 months after first study-related visit)
Secondary	Patient-Reported Outcome: Problem Areas in Diabetes	5-item Problem Areas in Diabetes (PAID-5) + Worry about Hypoglycemia	6 and 12 months following the first study-related visit
Secondary	Clinical Utilization Outcome: Hypoglycemic-related admissions to Emergency Department or Hospital	Hypoglycemic-related admissions in the 6 months and 12 months following the first study-related visit	6 and 12 months following the first study-related visit
Secondary	Patient-Centered Outcome: RAND Patient Satisfaction Questionnaire	5-item RAND Patient Satisfaction Questionnaire (PSQ III)	6 and 12 months following the first study-related visit
Secondary	Patient-Centered Outcome: Perceived Efficacy in Patient - Physician Interactions	5-item Perceived Efficacy in Patient - Physician Interactions (PEPPI) Survey Instrument	6 and 12 months following the first study-related visit
Secondary	Patient-Centered Outcome: Active Patient Participation during primary care visits	In a subset of patients (n = 40 in each arm, total n = 80), we will audio-record a selected primary care visit. Visit transcripts will be analyzed using the Active Patient Participation Coding Scheme [Coding Instrument] and utterances per unit time [Outcome Measure] demonstrating active patient participation related to diabetes management will be compared between arms.	6 - 12 months following the first study-related visit
Secondary	Medication-Related Outcome: Aggregate measure of diabetes medication deprescribing	Aggregate measure of diabetes medication deprescribing between baseline and 12-month follow-up, defined as any combination of: Discontinuation of either insulin or SU,; Reduction in dose of insulin or SU,; Switch from a higher risk to lower risk version of insulin (e.g. from sliding scale insulin or basal-bolus insulin to twice daily basal insulin) and/or higher risk to lower risk oral medicine (e.g. switching from SU to other oral medicine less associated with hypoglycemia).	12 months following the first study-related visit