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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
669
Educational video and Action Plan handout
Control arm patients will continue with usual care
Kaiser Permanente - Oakland Medical Center
Oakland, California, United States
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
Time frame: 12 months after baseline date
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
Time frame: Preceding 6-month period (asked 6 and 12 months after first study-related visit)]
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)
Time frame: Preceding 1-month period (asked 6 and 12 months after first study-related visit)
Patient-Reported Outcome: Problem Areas in Diabetes
5-item Problem Areas in Diabetes (PAID-5) + Worry about Hypoglycemia
Time frame: 6 and 12 months following the first study-related visit
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
Time frame: 6 and 12 months following the first study-related visit
Patient-Centered Outcome: RAND Patient Satisfaction Questionnaire
5-item RAND Patient Satisfaction Questionnaire (PSQ III)
Time frame: 6 and 12 months following the first study-related visit
Patient-Centered Outcome: Perceived Efficacy in Patient - Physician Interactions
5-item Perceived Efficacy in Patient - Physician Interactions (PEPPI) Survey Instrument
Time frame: 6 and 12 months following the first study-related visit
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.
Time frame: 6 - 12 months following the first study-related visit
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).
Time frame: 12 months following the first study-related visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.