Prepare for Your Diabetes Care

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Patient Activation; Type 2 Diabetes Mellitus With Hypoglycemia
• Intervention / Treatment: Behavioral: Prepare for Your Diabetes Care; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilana Peterson, MPH; Phone Number: 877-220-3022; Email: prepareresearchstudy@kp.org
• Study Contact Backup: Name: Richard W Grant, MD MPH; Email: Richard.W.Grant@kp.org

Study Locations

• United States
  • California
    • Oakland, California, United States, 94577
      • Recruiting
      • Kaiser Permanente - Oakland Medical Center
      • Contact: Project Coordinator
      • Contact: Phone Number: 877-220-3022; Email: prepareresearchstudy@kp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational Video and Action Plan handout; Patients in the intervention arm will be given access to an educational video (Prepare for Your Diabetes Care) and will be supported in viewing the video and the Action Plan handout. This program will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps with the participant's primary care provider.	Behavioral: Prepare for Your Diabetes Care; Educational video and Action Plan handout
Active Comparator: Usual Care; Patients in the control arm will continue with usual care and also complete baseline, 6-month, and 12-month surveys	Behavioral: Usual Care; Control arm patients will continue with usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)]
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)
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Richard W Grant, MD MPH, Kaiser Permanente Northern California - Division of Research

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
• Other Study ID Numbers: IRB-1635322; R01AG068133 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No