Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

NCT05566847 | Unknown

• 1 other identifier: 12-21-OTI-02
• Study Type: interventional
• Target: 817
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (14)

• Time to achievement of glycemic targets (HbA1c<7%, <8%, and <9%)

  18 months

• Adherence to HbA1c monitoring

  6 months

• Adherence to HbA1c monitoring

  12 months

• Adherence to HbA1c monitoring

  18 months

• Time to metformin initiation

  18 months

Study Arms (3)

Arm 1: Usual Care

NO INTERVENTION

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

Arm 2: Physician Education

EXPERIMENTAL

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

Other: Physician Education

Arm 3: Physician Education + Accountable Population Manager Outreach

EXPERIMENTAL

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; Other: Accountable Population Manager outreach

Interventions

Physician Education 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 2: Physician Education; Arm 3: Physician Education + Accountable Population Manager Outreach

Accountable Population Manager outreach 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.

Arm 3: Physician Education + Accountable Population Manager Outreach

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Evidence of preceding T2D diagnosis
• Pregnant at the time of T2D diagnosis
• Likely to have Type 1 diabetes

Sponsors & Collaborators

• Kaiser Permanente: lead
• American Diabetes Association: collaborator

Study Sites (1)

Kaiser Permanente Division of Research

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lisa Gilliam, MD, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Anjali Gopalan, MD, MS

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Richard Grant, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 4, 2022
• Study Start: September 7, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)