Aging, Patient Activation, Type 2 Diabetes Mellitus With Hypoglycemia
Conditions
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.
Interventions
BEHAVIORALPrepare for Your Diabetes Care
Educational video and Action Plan handout
BEHAVIORALUsual Care
Control arm patients will continue with usual care
Sponsors
Kaiser Permanente
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
care provider will not be informed of patient status; outcomes assessor will be blinded to allocation status
Intervention model description
pragmatic, clinical efficacy, patient-level randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any incidence of hypoglycemia | 12 months after baseline date | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcome: Incidence of Severe Self-Reported Hypoglycemia | Preceding 6-month period (asked 6 and 12 months after first study-related visit)] | 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 |
| Patient-Reported Outcome: Incidence of Symptomatic Self-Reported Hypoglycemia | Preceding 1-month period (asked 6 and 12 months after first study-related visit) | Patient report of three or more self-reported symptomatic episodes in past 4 weeks (measured at 6- and 12-months) |
| Patient-Reported Outcome: Problem Areas in Diabetes | 6 and 12 months following the first study-related visit | 5-item Problem Areas in Diabetes (PAID-5) + Worry about Hypoglycemia |
| Clinical Utilization Outcome: Hypoglycemic-related admissions to Emergency Department or Hospital | 6 and 12 months following the first study-related visit | Hypoglycemic-related admissions in the 6 months and 12 months following the first study-related visit |
| Patient-Centered Outcome: RAND Patient Satisfaction Questionnaire | 6 and 12 months following the first study-related visit | 5-item RAND Patient Satisfaction Questionnaire (PSQ III) |
| Patient-Centered Outcome: Perceived Efficacy in Patient - Physician Interactions | 6 and 12 months following the first study-related visit | 5-item Perceived Efficacy in Patient - Physician Interactions (PEPPI) Survey Instrument |
| Patient-Centered Outcome: Active Patient Participation during primary care visits | 6 - 12 months following the first study-related visit | 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. |
| Medication-Related Outcome: Aggregate measure of diabetes medication deprescribing | 12 months following the first study-related visit | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRichard W Grant, MD MPH
Kaiser Permanente Northern California - Division of Research
Outcome results
None listed