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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04585191
Other study ID # CDR-2019C1-16126
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2, 2020
Est. completion date September 2024

Study information

Verified date April 2024
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 450
Est. completion date September 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - age = 75 - type 2 diabetes with last measured HbA1c = 8.0% - currently prescribed insulin and/or 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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 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.
Other:
Attention Control Educational Handout
Attention control is an existing health education handout that provides some general health advice geared towards older patients.

Locations

Country Name City State
United States Kaiser Permanente South San Francisco San Francisco California
United States Kaiser Permanente Northern California San Leandro California
United States Kaiser Permanente Union City Union City California
United States Kaiser Permanente Vallejo Vallejo California

Sponsors (2)

Lead Sponsor Collaborator
Kaiser Permanente Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other HbA1c Change from baseline to study completion, an average of 1 year Change in HbA1c level between baseline and follow-up 1 year following the first study-related visit
Primary Clinical Outcome: Number of Participants with glycemic regimen de-prescribing Aggregate measure of diabetes medication deprescribing between baseline and 6-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).
6 months after initial primary care visit
Primary Patient-Reported Outcome: Number of Participants with Self-Reported Hypoglycemia Patient report of any low blood sugar episode in past 6 months that resulted in passing out or needing help from someone else Preceding 6 month period (asked 6 months after initial primary care visit)
Secondary Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire Diabetes Treatment Satisfaction Questionnaire scores Asked 6 months after initial primary care visit
Secondary Number of Participants with Hypoglycemic-related hospitalizations Hypoglycemic-related hospitalizations in the 6 months following the first study-related visit. 6 months following the first study-related visit
Secondary Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire RAND Patient Satisfaction Questionnaire 6 months following the first study-related visit
Secondary Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions Perceived Efficacy in Patient - Physician Interactions 5 - Item Survey 6 months following the first study-related visit
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