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Proactive Non-Physician Outreach for Type 2 Diabetes

N/A

Waitlist Available

Led By Lisa Gilliam, MD, PhD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Kaiser Permanente Northern California (KPNC) member age 18-74

Incident Type 2 Diabetes

Must not have

Evidence of preceding T2D diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether or not proactive outreach by a non-physician clinician to patients with newly diagnosed Type 2 diabetes can help them better manage their disease.

Who is the study for?

This trial is for adults aged 18-74 who are members of Kaiser Permanente Northern California, have recently been diagnosed with Type 2 Diabetes, and haven't started on metformin despite having an A1c level between 6.5-7.9%. Pregnant individuals or those likely to have Type 1 diabetes, or a previous diagnosis of T2D are excluded.

What is being tested?

The study tests if proactive outreach by non-physician clinicians (Accountable Population Managers) can help patients newly diagnosed with Type 2 Diabetes start treatment early and reach blood sugar targets within six months.

What are the potential side effects?

Since the interventions involve education and outreach rather than medications, there may not be direct side effects like those associated with drugs; however, participants might experience stress or anxiety from increased engagement about their health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 74 years old and a member of Kaiser Permanente Northern California.

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I have been diagnosed with Type 2 Diabetes recently.

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My diabetes treatment with metformin hasn't changed despite needing adjustment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HbA1c<7%

HbA1c<8%

HbA1c<9%

Secondary study objectives

Absolute mean reduction in HbA1c from baseline

Adherence to HbA1c monitoring

Emergency room visits and hospitalizations post-intervention start

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 3: Physician Education + Accountable Population Manager OutreachExperimental Treatment2 Interventions

Physicians in service areas randomized to this arm were invited to a physician education session on therapeutic inertia. Patients enrolled in this arm may receive proactive outreach from an Accountable Population Manager (APM).

Group II: Arm 2: Physician EducationExperimental Treatment1 Intervention

Physicians in service areas randomized to this arm were invited to a physician education session on therapeutic inertia.

Group III: Arm 1: Usual CareActive Control1 Intervention

Participants will receive standard care for newly diagnosed Type 2 Diabetes.

0 / 4Eligibility criteria met