Type 2 Diabetes
Conditions
Brief summary
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.
Detailed 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.
Interventions
OTHERPhysician Education
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.
OTHERAccountable Population Manager outreach
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.
Sponsors
American Diabetes Association
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c<7% | 6 months | Proportion of patients with HbA1c less than 7% at 6 months following the start of the intervention. |
| HbA1c<8% | 6 months | Proportion of patients with HbA1c less than 8% at 6 months following the start of the intervention. |
| HbA1c<9% | 6 months | Proportion of patients with HbA1c less than 9% at 6 months following the start of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metformin adherence | 6 months | Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. \<80%) |
| Time to initiation of non-metformin anti-diabetes medication | 18 months | Time elapsed |
| Time to achievement of glycemic targets (HbA1c<7%, <8%, and <9%) | 18 months | Time elapsed |
| Emergency room visits and hospitalizations post-intervention start | 18 months | Emergency room visits and hospitalizations within 18 months of intervention start |
| Hypoglycemia events post-intervention start | 18 months | Hypoglycemia events within 18 months of intervention start |
| Absolute mean reduction in HbA1c from baseline | 6 months | Absolute mean reduction in HbA1c from baseline to 6 months following intervention |
| Adherence to HbA1c monitoring | 6 months | New HbA1c value at follow-up time points |
| Time to metformin initiation | 18 months | Time elapsed |
Countries
United States
Outcome results
None listed