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Completed

NCT Number: NCT04585191

Reducing Treatment Risk in Older Adults With Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Treated With Insulin Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases Polypharmacy Primary Health Care

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente South San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Attention Control Educational Handout

Other

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

Primary outcomes

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

    Time frame: 6 months after initial primary care visit

    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:

    • Discontinuation of either insulin or a sulfonylureas (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).

  2. Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia

    Time frame: Preceding 6 month period (asked 6 months after initial primary care visit)

    Patient report of any low blood sugar episode in past 6 months that resulted in passing out or needing help from someone else

Secondary outcomes

  1. Diabetes Treatment Satisfaction Questionnaire Scores

    Time frame: Asked 6 months after initial primary care visit

    Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire [8 items, scores 0 - 36, higher score is better]

  2. Number of Participants With Hypoglycemic-related Hospitalizations

    Time frame: 6 months following the first study-related visit

    Hypoglycemic-related hospitalizations in the 6 months following the first study-related visit.

  3. RAND Patient Satisfaction Questionnaire

    Time frame: 6 months following the first study-related visit

    Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire [5 item, score 5- 25, higher is worse]

  4. Perceived Efficacy in Patient - Physician Interactions

    Time frame: 6 months following the first study-related visit

    Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions (5 - Item Survey, score 5-25, higher is better)

Other outcomes

  1. Change in HbA1c Level

    Time frame: 1 year following the first study-related visit

    HbA1c Change from baseline to study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Reducing Treatment Risk in Older Patients With Diabetes: Comparative Effectiveness of Academic Detailing With and Without Pre-Visit Patient Preparation

Acronym: RETRO-DM

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 14, 2020
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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