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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05263310
Other study ID # IRB-1635322
Secondary ID R01AG068133
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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