Population Health Management for KPNC Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Augmented Initial Type 2 Diabetes Care.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes (T2D). Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Population Health Management for Kaiser Permanente Northern California (KPNC) Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy
Overview
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.
Interventions
- Behavioral Augmented Initial Type 2 Diabetes Care
The intervention will include 4 components: 1) Making primary care providers (PCPs) aware that the patient has been selected to receive "Augmented Initial Type 2 Diabetes (T2D) Care", 2) encouraging early care manager outreach to establish care, ensure prescribing of appropriate medications, and support medication adherence, 3) a one-on-one virtual health educator visit to reinforce self-management education and ensure set-up of remote glucose monitoring or continuous glucose monitoring (if elig
Primary outcome measures
- Average hemoglobin A1c (HbA1c) [Time frame: 6-months]
- Average hemoglobin A1c (HbA1c) [Time frame: 12-months]
Secondary outcome measures (10)
- Time to achievement of glycemic targets [Time frame: 6-months]
- Time to achievement of glycemic targets [Time frame: 12-months]
- Adherence to HbA1c monitoring [Time frame: 6-months]
- Adherence to HbA1c monitoring [Time frame: 12-months]
- Type 2 diabetes medication and statin initiation [Time frame: 6-months]
- Type 2 diabetes medication and statin initiation [Time frame: 12-months]
- Type 2 diabetes medication adherence [Time frame: 6-months]
- Type 2 diabetes medication adherence [Time frame: 12-months]
- Completion of preventative screening [Time frame: 6-months]
- Completion of preventative screening [Time frame: 12-months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Kaiser Permanente Division of Research — Pleasanton
Identifiers
NCT: NCT06906653 · 2220224