Reducing Treatment Risk in Older Adults With Diabetes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2024-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the impact of academic detailing (evidence-based provider education) with or without patient pre-visit preparation (elicitation of values and preferences) on safe insulin de-prescribing among older patients with type 2 diabetes at risk for hypoglycemia. The hypothesis is that patients who are well-prepared for their primary care visit will engage in more informed discussions with their providers regarding re-evaluation of current treatment regimens. In clinically appropriate cases, these more effective discussions will result in safe de-prescribing and fewer future episodes of hypoglycemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pre-Visit Prioritization for Complex Patients With Diabetes

NCT02375932

Diabetes Mellitus, Type 2

COMPLETED NA

Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care

NCT00668590

Diabetes

COMPLETED NA

Simulated Diabetes Training for Resident Physicians

NCT00979823

Type 2 Diabetes

COMPLETED NA

Improving Diabetes Outcomes With Activity, Nutrition and Medication

NCT00179374

Diabetes Mellitus, Type 2

COMPLETED NA

Impact of a Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes

NCT05893927

Diabetes Mellitus, Type 2 Diabetes Education Lifestyle Modification

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this comparative effectiveness clinical trial, primary care physicians (PCPs) will receive 2 academic detailing sessions 6 months apart. Eligible patients (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas \[SUs\], and last measured HbA1c \<=8%) of these PCPs will be randomized to receive either a pre-visit conversation aid/communication tool that elicits values and preferences regarding safe insulin/SU deprescribing \[Intervention\] or a general health education handout ("Embracing Life as You Age") \[Attention Control\]. Patient-reported outcomes (e.g., self-reported hypoglycemia episodes) and clinical outcomes (e.g., changes in glycemic regimen) will be compared between study arms. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Treated With Insulin Hypoglycemia Primary Health Care Polypharmacy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are two arms within the Comparative Effectiveness Randomized Clinical Trial (CE-RCT). All eligible primary care physicians (PCPs) will receive academic detailing. Eligible and consenting patients of these PCPs will be randomly allocated to intervention vs attention control arms grouped by PCP. (There will be a secondary, parallel comparison group to measure temporal trends in care for similar patients at other facilities in our care system not involved in the clinical trial.)

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre-Visit Conversation Aid

Patients in the intervention arm will receive a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" prior to a scheduled appointment with their primary care physician (PCP). This document 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.

Group Type EXPERIMENTAL

Conversation Aid

Intervention Type BEHAVIORAL

Intervention is a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" that patients receive prior to a scheduled appointment with their primary care physician (PCP). This document 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.

General Health Education Handout

Patients in the attention control arm will receive an existing 1-page health education handout entitled "Embracing Life as You Age" which provides some general advice geared towards older patients such as remaining physically active, limiting sun exposure, and eating well.

Group Type ACTIVE_COMPARATOR

Attention Control Educational Handout

Intervention Type OTHER

Attention control is an existing health education handout that provides some general health advice geared towards older patients.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conversation Aid

Intervention is a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" that patients receive prior to a scheduled appointment with their primary care physician (PCP). This document 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.

Intervention Type BEHAVIORAL

Attention Control Educational Handout

Attention control is an existing health education handout that provides some general health advice geared towards older patients.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age ≥ 75 years
* type 2 diabetes with last measured Hemoglobin A1c (HbA1c) ≤ 8.0%
* currently prescribed insulin and/or sulfonylureas (SUs)
* Kaiser Permanente Northern California member

Exclusion Criteria

* Given the requirements of this funding mechanism, we will not be able to develop new patient materials in languages other than English, and patients unable to communicate in English will be excluded.
* Similarly, patients unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits will be excluded.
* Excluded by their primary care provider

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No