Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05566847
• Other study ID #: 12-21-OTI-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 817
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Division of Research	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

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