Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Physician Education; Other: Accountable Population Manager outreach

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 Type: Interventional
• Enrollment (Actual): 817
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Division of Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Lisa Gilliam, MD, PhD, Kaiser Permanente; Principal Investigator: Anjali Gopalan, MD, MS, Kaiser Permanente; Principal Investigator: Richard Grant, MD, MPH, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 12-21-OTI-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No