Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

Kaiser Permanente

Status: Active, not recruiting

Conditions: Type 2 Diabetes

Treatments: Other: Physician Education; Other: Accountable Population Manager outreach

Study type: Interventional

Funder types: Other

Identifiers

NCT05566847

12-21-OTI-02

Details and patient eligibility

About

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.

Full description

This is a 3-arm randomized clinical trial comparing patients in the following arms: 1) usual Type 2 diabetes care, 2) primary care physicians have been exposed to physician education on therapeutic inertia, and 3) primary care physicians have been exposed to physician education on therapeutic inertia and patients are referred to APM proactive outreach. The APM is a non-physician clinician, including clinical pharmacists and nurses. Eligible members will be identified via electronic health record (EHR) data in two stages: 1) identification of individuals with newly diagnosed T2D, 2) identification of the subset of newly diagnosed individuals with metformin-related therapeutic inertia. The content of the APM visit will be the same as what currently occurs in standard diabetes care, including discussing the risks and benefits of pharmacologic treatment and initiating treatment (with patient agreement), supporting medication adherence, and providing education and support for overall T2D management. The main outcome will be HbA1c at 6, 12, and 18 months post-intervention.

Enrollment: 817 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Kaiser Permanente Northern California (KPNC) member age 18-74
• Incident Type 2 Diabetes
• Patient of primary care physician (PCP) working in the randomized service areas
• Identified metformin-related therapeutic inertia
• At least one A1c 6.5-7.9 from 4 months post-diagnosis up to the time of randomization

Exclusion criteria

• Evidence of preceding T2D diagnosis
• Pregnant at the time of T2D diagnosis
• Likely to have Type 1 diabetes

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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817 participants in 3 patient groups

Arm 1: Usual Care

No Intervention group

Description:

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

Arm 2: Physician Education

Experimental group

Description:

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

Treatment:

Other: Physician Education

Arm 3: Physician Education + Accountable Population Manager Outreach

Experimental group

Description:

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).

Treatment:

Other: Physician Education

Other: Accountable Population Manager outreach