Trial Outcomes & Findings for Reducing Treatment Risk in Older Adults With Diabetes (NCT NCT04585191)

Last Updated: 2025-03-21

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

450 participants

Primary outcome timeframe

6 months after initial primary care visit

Results posted on

2025-03-21

Participant Flow

Patients provided informed consent and were enrolled into the study. All study outcomes are measured at the patient level, with clustering within primary care physician panel accounted for in all outcome analyses.

Among primary care physicians (PCPs) who attended the academic detailing sessions, their study eligible patients provided informed consent, were enrolled in the study, and are the subject of all outcome analyses. PCPs assented to participate but were not asked to provide informed consent and are therefore not considered the primary subjects of this RCT.

Participant milestones

Participant milestones
Measure	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. 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.	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. Attention Control Educational Handout: Attention control is an existing health education handout that provides some general health advice geared towards older patients.
Overall Study STARTED	232	218
Overall Study COMPLETED	232	218
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Treatment Risk in Older Adults With Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-Visit Conversation Aid n=232 Participants 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. 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.	General Health Education Handout n=218 Participants 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. Attention Control Educational Handout: Attention control is an existing health education handout that provides some general health advice geared towards older patients.	Total n=450 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	232 Participants n=5 Participants	218 Participants n=7 Participants	450 Participants n=5 Participants
Age, Continuous	79.7 years STANDARD_DEVIATION 3.9 • n=5 Participants	80.2 years STANDARD_DEVIATION 4.2 • n=7 Participants	79.9 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants	112 Participants n=7 Participants	223 Participants n=5 Participants
Sex: Female, Male Male	121 Participants n=5 Participants	106 Participants n=7 Participants	227 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	35 Participants n=5 Participants	42 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Black/African-American	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Race/Ethnicity, Customized Asian	39 Participants n=5 Participants	34 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Multi/Other	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Missing/Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	110 Participants n=5 Participants	101 Participants n=7 Participants	211 Participants n=5 Participants
Region of Enrollment United States	232 participants n=5 Participants	218 participants n=7 Participants	450 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after initial primary care visit

Outcome measures

Outcome measures
Measure	Pre-Visit Conversation Aid n=232 Participants 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. 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.	General Health Education Handout n=218 Participants 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. Attention Control Educational Handout: Attention control is an existing health education handout that provides some general health advice geared towards older patients.
Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing	34 Participants	21 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pre-Visit Conversation Aid n=232 Participants 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. 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.	General Health Education Handout n=218 Participants 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. Attention Control Educational Handout: Attention control is an existing health education handout that provides some general health advice geared towards older patients.
Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia	10 Participants	13 Participants

Adverse Events

Pre-Visit Conversation Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

General Health Education Handout

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard Grant

Division of Research, Kaiser Permanente Northern California

Phone: 5108213969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place