Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

Study Overview
=================
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.

Official Title
-----------------
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Physician Education
* Other: Accountable Population Manager outreach


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1: Usual Care<br>Participants will receive standard care for newly diagnosed Type 2 Diabetes. | |
| Experimental: Arm 2: Physician Education<br>Physicians in service areas randomized to this arm were invited to a physician education session on therapeutic inertia. | Other: Physician Education<br>* 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.<br>|
| Experimental: Arm 3: Physician Education + Accountable Population Manager Outreach<br>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). | Other: Physician Education<br>* 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.<br>Other: Accountable Population Manager outreach<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c<7% | Proportion of patients with HbA1c less than 7% at 6 months following the start of the intervention. | 6 months | 
| HbA1c<7% | Proportion of patients with HbA1c less than 7% at 12 months following the start of the intervention. | 12 months | 
| HbA1c<7% | Proportion of patients with HbA1c less than 7% at 18 months following the start of the .intervention. | 18 months | 
| HbA1c<8% | Proportion of patients with HbA1c less than 8% at 6 months following the start of the intervention. | 6 months | 
| HbA1c<8% | Proportion of patients with HbA1c less than 8% at 12 months following the start of the intervention. | 12 months | 
| HbA1c<8% | Proportion of patients with HbA1c less than 8% at 18 months following the start of the intervention. | 18 months | 
| HbA1c<9% | Proportion of patients with HbA1c less than 9% at 6 months following the start of the intervention. | 6 months | 
| HbA1c<9% | Proportion of patients with HbA1c less than 9% at 12 months following the start of the intervention. | 12 months | 
| HbA1c<9% | Proportion of patients with HbA1c less than 9% at 18 months following the start of the intervention. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achievement of glycemic targets (HbA1c<7%, <8%, and <9%) | Time elapsed | 18 months | 
| Adherence to HbA1c monitoring | New HbA1c value at follow-up time points | 6 months | 
| Adherence to HbA1c monitoring | New HbA1c value at follow-up time points | 12 months | 
| Adherence to HbA1c monitoring | New HbA1c value at follow-up time points | 18 months | 
| Time to metformin initiation | Time elapsed | 18 months | 
| Metformin adherence | Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%) | 6 months | 
| Metformin adherence | Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%) | 12 months | 
| Metformin adherence | Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%) | 18 months | 
| Time to initiation of non-metformin anti-diabetes medication | Time elapsed | 18 months | 
| Absolute mean reduction in HbA1c from baseline | Absolute mean reduction in HbA1c from baseline to 6 months following intervention | 6 months | 
| Absolute mean reduction in HbA1c from baseline | Absolute mean reduction in HbA1c from baseline to 12 months following intervention | 12 months | 
| Absolute mean reduction in HbA1c from baseline | Absolute mean reduction in HbA1c from baseline to 18 months following intervention | 18 months | 
| Emergency room visits and hospitalizations post-intervention start | Emergency room visits and hospitalizations within 18 months of intervention start | 18 months | 
| Hypoglycemia events post-intervention start | Hypoglycemia events within 18 months of intervention start | 18 months |