Reducing Treatment Risk in Older Adults With Diabetes

NCT04585191 | Completed Results

• 1 other identifier: CDR-2019C1-16126
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Type 2 Diabetes Treated With Insulin; Hypoglycemia; Primary Health Care; Polypharmacy

Keywords

clinical trial

Outcome Measures

Primary Outcomes (2)

• Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing

  Aggregate binary measure of diabetes medication deprescribing between baseline and 6-month follow-up. Greater de-prescribing is better. De-prescribing defined as any combination of: 1. Discontinuation of either insulin or a sulfonylureas (SU) 2. Reduction in dose of insulin or SU, 3. 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

• 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 Outcomes (4)

• Diabetes Treatment Satisfaction Questionnaire Scores

  Asked 6 months after initial primary care visit

• Number of Participants With Hypoglycemic-related Hospitalizations

  6 months following the first study-related visit

• RAND Patient Satisfaction Questionnaire

  6 months following the first study-related visit

• Perceived Efficacy in Patient - Physician Interactions

  6 months following the first study-related visit

Other Outcomes (1)

• Change in HbA1c Level

  1 year following the first study-related visit

Study Arms (2)

Pre-Visit Conversation Aid

EXPERIMENTAL

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.

Behavioral: Conversation Aid

General Health Education Handout

ACTIVE COMPARATOR

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.

Other: Attention Control Educational Handout

Interventions

Conversation Aid 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.

Pre-Visit Conversation Aid

Attention Control Educational Handout OTHER

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

General Health Education Handout

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

Kaiser Permanente South San Francisco

San Francisco, California, 94080, United States

Location

Kaiser Permanente Northern California

San Leandro, California, 94577, United States

Location

Kaiser Permanente Union City

Union City, California, 94587, United States

Location

Kaiser Permanente Vallejo

Vallejo, California, 94589, United States

Location

Related Publications (1)

• Grant RW, Peterson I, McCloskey JM, Lipska KJ, Nugent J, Karter AJ, Gilliam LK. Diabetes Deprescribing in Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 1;185(8):926-935. doi: 10.1001/jamainternmed.2025.2015.

  PMID: 40549370 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Richard Grant
• Organization: Division of Research, Kaiser Permanente Northern California

Richard.W.Grant@kp.org

5108213969

Study Officials

• Richard W Grant, MD MPH

  Division of Research, Kaiser Permanente Northern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.)

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 14, 2020
• Study Start: November 2, 2020
• Primary Completion: March 30, 2024
• Study Completion: September 1, 2024
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)