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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
817
The physician education session delivered to primary care physicians in Arms 2 and 3 will provide an educational update from the regional clinical leader for diabetes regarding guidelines for diabetes treatment and addressing therapeutic inertia.
Patients will be referred to an Accountable Population Manager (APM) for proactive outreach, including supporting medication adherence and educational and overall support for T2D management. An APM is a non-physician clinician (for example, a clinical pharmacist) supporting diabetes management.
Kaiser Permanente Division of Research
Oakland, California, United States
HbA1c<7%
Proportion of patients with HbA1c less than 7% at 6 months following the start of the intervention.
Time frame: 6 months
HbA1c<7%
Proportion of patients with HbA1c less than 7% at 12 months following the start of the intervention.
Time frame: 12 months
HbA1c<7%
Proportion of patients with HbA1c less than 7% at 18 months following the start of the .intervention.
Time frame: 18 months
HbA1c<8%
Proportion of patients with HbA1c less than 8% at 6 months following the start of the intervention.
Time frame: 6 months
HbA1c<8%
Proportion of patients with HbA1c less than 8% at 12 months following the start of the intervention.
Time frame: 12 months
HbA1c<8%
Proportion of patients with HbA1c less than 8% at 18 months following the start of the intervention.
Time frame: 18 months
HbA1c<9%
Proportion of patients with HbA1c less than 9% at 6 months following the start of the intervention.
Time frame: 6 months
HbA1c<9%
Proportion of patients with HbA1c less than 9% at 12 months following the start of the intervention.
Time frame: 12 months
HbA1c<9%
Proportion of patients with HbA1c less than 9% at 18 months following the start of the intervention.
Time frame: 18 months
Time to achievement of glycemic targets (HbA1c<7%, <8%, and <9%)
Time elapsed
Time frame: 18 months
Adherence to HbA1c monitoring
New HbA1c value at follow-up time points
Time frame: 6 months
Adherence to HbA1c monitoring
New HbA1c value at follow-up time points
Time frame: 12 months
Adherence to HbA1c monitoring
New HbA1c value at follow-up time points
Time frame: 18 months
Time to metformin initiation
Time elapsed
Time frame: 18 months
Metformin adherence
Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. \<80%)
Time frame: 6 months
Metformin adherence
Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. \<80%)
Time frame: 12 months
Metformin adherence
Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. \<80%)
Time frame: 18 months
Time to initiation of non-metformin anti-diabetes medication
Time elapsed
Time frame: 18 months
Absolute mean reduction in HbA1c from baseline
Absolute mean reduction in HbA1c from baseline to 6 months following intervention
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Time frame: 6 months
Absolute mean reduction in HbA1c from baseline
Absolute mean reduction in HbA1c from baseline to 12 months following intervention
Time frame: 12 months
Absolute mean reduction in HbA1c from baseline
Absolute mean reduction in HbA1c from baseline to 18 months following intervention
Time frame: 18 months
Emergency room visits and hospitalizations post-intervention start
Emergency room visits and hospitalizations within 18 months of intervention start
Time frame: 18 months
Hypoglycemia events post-intervention start
Hypoglycemia events within 18 months of intervention start
Time frame: 18 months