Population Health Management for KPNC Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy

Kaiser Permanente

Status: Invitation-only

Conditions: Type 2 Diabetes (T2D); Type 2 Diabetes Mellitus (T2DM); Type 2 Diabetes

Treatments: Behavioral: Augmented Initial Type 2 Diabetes Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06906653

2220224

Details and patient eligibility

About

This study is a 2-arm randomized trial of Augmented Initial Type 2 Diabetes (T2D) Care vs. Usual Initial T2D Care among adults (18-74 years) with newly diagnosed T2D who have risk factors (defined by age and diagnosis HbA1c value) for suboptimal early glycemic control. Augmented Initial T2D Care comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team. The study team will use electronic health record (EHR) data to assess between-arm differences in diabetes-related outcomes at 6- and 12 months.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-74 years
• Newly diagnosed with type 2 diabetes
• Kaiser Permanente Northern California member receiving care in a participating service area
• If age ≤45 years, then HbA1c>8%
• If age<45 years, then HbA1c>10%

Exclusion criteria

• Individuals who are pregnant
• Individuals with likely type 1 diabetes (T1D)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Usual Initial Type 2 Diabetes (T2D) Care

No Intervention group

Description:

Patients in the usual care arm will receive the standard T2D care provided to Kaiser Permanente Northern California members with recently diagnosed T2D. This care includes any counseling or treatment recommendations made by the primary care provider and the assigned care manager.

Augmented Initial Type 2 Diabetes (T2D) Care

Experimental group

Description:

The intervention - Augmented Initial T2D Care - comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team and self-management support by care managers, health educators, and dieticians.

Treatment:

Behavioral: Augmented Initial Type 2 Diabetes Care