Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Other: Physician Education; Other: Accountable Population Manager outreach

• Registration Number: NCT05566847
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study Start: 2022-09-07
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 817

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3: Physician Education + Accountable Population Manager Outreach	Physician Education	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).
Arm 2: Physician Education	Physician Education	Physicians in service areas randomized to this arm were invited to a physician education session on therapeutic inertia.
Arm 3: Physician Education + Accountable Population Manager Outreach	Accountable Population Manager outreach	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).

Primary Outcome Measures

Name	Time	Method
HbA1c<7%	18 months	Proportion of patients with HbA1c less than 7% at 18 months following the start of the .intervention.
HbA1c<8%	18 months	Proportion of patients with HbA1c less than 8% at 18 months following the start of the intervention.
HbA1c<9%	18 months	Proportion of patients with HbA1c less than 9% at 18 months following the start of the intervention.

Secondary Outcome Measures

Name	Time	Method
Adherence to HbA1c monitoring	18 months	New HbA1c value at follow-up time points
Emergency room visits and hospitalizations post-intervention start	18 months	Emergency room visits and hospitalizations within 18 months of intervention start
Time to metformin initiation	18 months	Time elapsed
Time to achievement of glycemic targets (HbA1c<7%, <8%, and <9%)	18 months	Time elapsed
Hypoglycemia events post-intervention start	18 months	Hypoglycemia events within 18 months of intervention start
Metformin adherence	18 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
Absolute mean reduction in HbA1c from baseline	18 months	Absolute mean reduction in HbA1c from baseline to 18 months following intervention

Trial Locations

Locations (1)

Kaiser Permanente Division of Research; 🇺🇸 Oakland, California, United States