Clinical trial NCT05263310: Prepare for Your Diabetes Care
Official title: Clinical Trial of Expanded Advance Care Planning to Address Regimen Intensity in Older Patients at High Risk for Treatment-Induced Hypoglycemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus With Hypoglycemia
Aging
Patient Activation
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-03-02
Enrollment: 600
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pragmatic, clinical efficacy, patient-level randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Any incidence of hypoglycemia
timeFrame: 12 months after baseline date
Secondary outcomes:
measure: Patient-Reported Outcome: Incidence of Severe Self-Reported Hypoglycemia
timeFrame: Preceding 6-month period (asked 6 and 12 months after first study-related visit)]
measure: Patient-Reported Outcome: Incidence of Symptomatic Self-Reported Hypoglycemia
timeFrame: Preceding 1-month period (asked 6 and 12 months after first study-related visit)
measure: Patient-Reported Outcome: Problem Areas in Diabetes
timeFrame: 6 and 12 months following the first study-related visit
measure: Clinical Utilization Outcome: Hypoglycemic-related admissions to Emergency Department or Hospital
timeFrame: 6 and 12 months following the first study-related visit
measure: Patient-Centered Outcome: RAND Patient Satisfaction Questionnaire
timeFrame: 6 and 12 months following the first study-related visit
measure: Patient-Centered Outcome: Perceived Efficacy in Patient - Physician Interactions
timeFrame: 6 and 12 months following the first study-related visit
measure: Patient-Centered Outcome: Active Patient Participation during primary care visits
timeFrame: 6 - 12 months following the first study-related visit
measure: Medication-Related Outcome: Aggregate measure of diabetes medication deprescribing
timeFrame: 12 months following the first study-related visit
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente Northern California - Division of Research
name: Richard W Grant, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: