Clinical trial NCT05566847: Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
Official title: Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2022-10-04
Enrollment: 817
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: HbA1c<7%
timeFrame: 6 months
measure: HbA1c<7%
timeFrame: 12 months
measure: HbA1c<7%
timeFrame: 18 months
measure: HbA1c<8%
timeFrame: 6 months
measure: HbA1c<8%
timeFrame: 12 months
measure: HbA1c<8%
timeFrame: 18 months
measure: HbA1c<9%
timeFrame: 6 months
measure: HbA1c<9%
timeFrame: 12 months
measure: HbA1c<9%
timeFrame: 18 months
Secondary outcomes:
measure: Time to achievement of glycemic targets (HbA1c<7%, <8%, and <9%)
timeFrame: 18 months
measure: Adherence to HbA1c monitoring
timeFrame: 6 months
measure: Adherence to HbA1c monitoring
timeFrame: 12 months
measure: Adherence to HbA1c monitoring
timeFrame: 18 months
measure: Time to metformin initiation
timeFrame: 18 months
measure: Metformin adherence
timeFrame: 6 months
measure: Metformin adherence
timeFrame: 12 months
measure: Metformin adherence
timeFrame: 18 months
measure: Time to initiation of non-metformin anti-diabetes medication
timeFrame: 18 months
measure: Absolute mean reduction in HbA1c from baseline
timeFrame: 6 months
measure: Absolute mean reduction in HbA1c from baseline
timeFrame: 12 months
measure: Absolute mean reduction in HbA1c from baseline
timeFrame: 18 months
measure: Emergency room visits and hospitalizations post-intervention start
timeFrame: 18 months
measure: Hypoglycemia events post-intervention start
timeFrame: 18 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
Study officials:
affiliation: Kaiser Permanente
name: Lisa Gilliam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Anjali Gopalan, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Richard Grant, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: