Reducing Treatment Risk in Older Adults With Diabetes (RETRO-DM)

• ClinicalTrials.gov Identifier: NCT04585191
• Recruitment Status: Recruiting
• First Posted: October 14, 2020
• Last Update Posted: December 9, 2021
• Sponsor: Kaiser Permanente
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Kaiser Permanente

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Treated With Insulin; Hypoglycemia; Primary Health Care; Polypharmacy	Behavioral: Conversation Aid; Other: Attention Control Educational Handout	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: There are two arms within the comparative effectiveness RCT. All eligible 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.)
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Reducing Treatment Risk in Older Patients With Diabetes: Comparative Effectiveness of Academic Detailing With and Without Pre-Visit Patient Preparation
• Actual Study Start Date: November 2, 2020
• Estimated Primary Completion Date: March 2024
• Estimated Study Completion Date: September 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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 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; 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.
Active Comparator: 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.	Other: Attention Control Educational Handout; Attention control is an existing health education handout that provides some general health advice geared towards older patients.

Outcome Measures

Primary Outcome Measures :

1. Clinical Outcome: Number of Participants with glycemic regimen de-prescribing [ Time Frame: 6 months after initial primary care visit ]

   Aggregate measure of diabetes medication deprescribing between baseline and 6-month follow-up, defined as any combination of:

   1. Discontinuation of either insulin or 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).
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 Outcome Measures :

1. Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire [ Time Frame: Asked 6 months after initial primary care visit ]
   Diabetes Treatment Satisfaction Questionnaire scores
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. Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire [ Time Frame: 6 months following the first study-related visit ]
   RAND Patient Satisfaction Questionnaire
4. Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions [ Time Frame: 6 months following the first study-related visit ]
   Perceived Efficacy in Patient - Physician Interactions 5 - Item Survey

Other Outcome Measures:

1. HbA1c Change from baseline to study completion, an average of 1 year [ Time Frame: 1 year following the first study-related visit ]
   Change in HbA1c level between baseline and follow-up

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Maruta Blatchins; (866) 445-0010; RETRO-Study@kp.org

Locations

United States, California

Kaiser Permanente South San Francisco; Recruiting

San Francisco, California, United States, 94080

Contact: Maruta A Blatchins

Kaiser Permanente Northern California; Recruiting

San Leandro, California, United States, 94577

Contact: Maruta A Blatchins

Kaiser Permanente Union City; Recruiting

Union City, California, United States, 94587

Contact: Maruta A Blatchins

Kaiser Permanente Vallejo; Recruiting

Vallejo, California, United States, 94589

Contact: Maruta A Blatchins

Sponsors and Collaborators

Kaiser Permanente

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Richard W Grant, MD MPH; Division of Research, Kaiser Permanente Northern California

More Information

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT04585191
• Other Study ID Numbers: CDR-2019C1-16126
• First Posted: October 14, 2020
• Last Update Posted: December 9, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Permanente:

clinical trial

Additional relevant MeSH terms:

Diabetes Mellitus; Hypoglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases