Proactive Non-Physician Outreach for Type 2 Diabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Preceding T2D, Pregnant, Type 1 diabetes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

817 Participants Needed

Trial Summary

What is the purpose of this trial?

Therapeutic inertia may result from providers, patients, and/or systems, but can be detrimental to a patients' health by putting them at risk for diabetes complications, though addressing it early can mitigate some of its effects. In Type 2 diabetes (T2D) care, this may look like failure to initiate metformin therapy early in the disease course. This project aims to evaluate the effects of proactive outreach by a non-physician clinician (Accountable Population Manager \[APM\]) to patients with newly diagnosed Type 2 diabetes. The team hypothesizes individuals receiving proactive outreach by an APM will be more likely to achieve glycemic targets at 6 months following start of the intervention.

Research Team

Anjali Gopalan, MD, MS

Principal Investigator

Kaiser Permanente

Lisa Gilliam, MD, PhD

Principal Investigator

Kaiser Permanente

Richard Grant, MD, MPH

Principal Investigator

Kaiser Permanente

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes recently.

Patient of primary care physician (PCP) working in the randomized service areas

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

Exclusion Criteria

I am likely to have Type 1 diabetes.

I have been diagnosed with type 2 diabetes.

You were pregnant when you were diagnosed with type 2 diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive proactive outreach by an Accountable Population Manager (APM) and/or physician education on therapeutic inertia

6 months

Regular visits as per standard diabetes care

Follow-up

Participants are monitored for glycemic targets and other outcomes post-intervention

18 months

Regular follow-up visits for HbA1c monitoring

Treatment Details

Interventions

• Accountable Population Manager outreach
• Physician Education

Trial Overview 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.

Participant Groups

Group I: Arm 3: Physician Education + Accountable Population Manager Outreach Experimental Treatment 2 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 Education Experimental Treatment 1 Intervention

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

Group III: Arm 1: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+