Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

NCT ID: NCT05566847

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 817 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-07
• Study Completion Date: 2025-03-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm 1: Usual Care

Participants will receive standard care for newly diagnosed Type 2 Diabetes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2: Physician Education

Physicians in service areas randomized to this arm were invited to a physician education session on therapeutic inertia.

Group Type: EXPERIMENTAL

Physician Education

Intervention Type: OTHER

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.

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).

Group Type: EXPERIMENTAL

Physician Education

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Gilliam, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Anjali Gopalan, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Richard Grant, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Division of Research

Oakland, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

12-21-OTI-02

Identifier Type: -

Identifier Source: org_study_id