Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician Education
Accountable Population Manager outreach
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes
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
Sites / Locations
- Kaiser Permanente Division of Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Arm 1: Usual Care
Arm 2: Physician Education
Arm 3: Physician Education + Accountable Population Manager Outreach
Arm Description
Participants will receive standard care for newly diagnosed Type 2 Diabetes.
Physicians in service areas randomized to this arm were invited to a physician education session on therapeutic inertia.
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).
Outcomes
Primary Outcome Measures
HbA1c<7%
Proportion of patients with HbA1c less than 7% at 6 months following the start of the intervention.
HbA1c<7%
Proportion of patients with HbA1c less than 7% at 12 months following the start of the intervention.
HbA1c<7%
Proportion of patients with HbA1c less than 7% at 18 months following the start of the .intervention.
HbA1c<8%
Proportion of patients with HbA1c less than 8% at 6 months following the start of the intervention.
HbA1c<8%
Proportion of patients with HbA1c less than 8% at 12 months following the start of the intervention.
HbA1c<8%
Proportion of patients with HbA1c less than 8% at 18 months following the start of the intervention.
HbA1c<9%
Proportion of patients with HbA1c less than 9% at 6 months following the start of the intervention.
HbA1c<9%
Proportion of patients with HbA1c less than 9% at 12 months following the start of the intervention.
HbA1c<9%
Proportion of patients with HbA1c less than 9% at 18 months following the start of the intervention.
Secondary Outcome Measures
Time to achievement of glycemic targets (HbA1c<7%, <8%, and <9%)
Time elapsed
Adherence to HbA1c monitoring
New HbA1c value at follow-up time points
Adherence to HbA1c monitoring
New HbA1c value at follow-up time points
Adherence to HbA1c monitoring
New HbA1c value at follow-up time points
Time to metformin initiation
Time elapsed
Metformin adherence
Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%)
Metformin adherence
Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%)
Metformin adherence
Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%)
Time to initiation of non-metformin anti-diabetes medication
Time elapsed
Absolute mean reduction in HbA1c from baseline
Absolute mean reduction in HbA1c from baseline to 6 months following intervention
Absolute mean reduction in HbA1c from baseline
Absolute mean reduction in HbA1c from baseline to 12 months following intervention
Absolute mean reduction in HbA1c from baseline
Absolute mean reduction in HbA1c from baseline to 18 months following intervention
Emergency room visits and hospitalizations post-intervention start
Emergency room visits and hospitalizations within 18 months of intervention start
Hypoglycemia events post-intervention start
Hypoglycemia events within 18 months of intervention start
Full Information
NCT ID
NCT05566847
First Posted
September 21, 2022
Last Updated
October 24, 2022
Sponsor
Kaiser Permanente
Collaborators
American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT05566847
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
American Diabetes Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Usual Care
Arm Type
No Intervention
Arm Description
Participants will receive standard care for newly diagnosed Type 2 Diabetes.
Arm Title
Arm 2: Physician Education
Arm Type
Experimental
Arm Description
Physicians in service areas randomized to this arm were invited to a physician education session on therapeutic inertia.
Arm Title
Arm 3: Physician Education + Accountable Population Manager Outreach
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Physician Education
Intervention Description
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
Intervention Name(s)
Accountable Population Manager outreach
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c<7%
Description
Proportion of patients with HbA1c less than 7% at 6 months following the start of the intervention.
Time Frame
6 months
Title
HbA1c<7%
Description
Proportion of patients with HbA1c less than 7% at 12 months following the start of the intervention.
Time Frame
12 months
Title
HbA1c<7%
Description
Proportion of patients with HbA1c less than 7% at 18 months following the start of the .intervention.
Time Frame
18 months
Title
HbA1c<8%
Description
Proportion of patients with HbA1c less than 8% at 6 months following the start of the intervention.
Time Frame
6 months
Title
HbA1c<8%
Description
Proportion of patients with HbA1c less than 8% at 12 months following the start of the intervention.
Time Frame
12 months
Title
HbA1c<8%
Description
Proportion of patients with HbA1c less than 8% at 18 months following the start of the intervention.
Time Frame
18 months
Title
HbA1c<9%
Description
Proportion of patients with HbA1c less than 9% at 6 months following the start of the intervention.
Time Frame
6 months
Title
HbA1c<9%
Description
Proportion of patients with HbA1c less than 9% at 12 months following the start of the intervention.
Time Frame
12 months
Title
HbA1c<9%
Description
Proportion of patients with HbA1c less than 9% at 18 months following the start of the intervention.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Time to achievement of glycemic targets (HbA1c<7%, <8%, and <9%)
Description
Time elapsed
Time Frame
18 months
Title
Adherence to HbA1c monitoring
Description
New HbA1c value at follow-up time points
Time Frame
6 months
Title
Adherence to HbA1c monitoring
Description
New HbA1c value at follow-up time points
Time Frame
12 months
Title
Adherence to HbA1c monitoring
Description
New HbA1c value at follow-up time points
Time Frame
18 months
Title
Time to metformin initiation
Description
Time elapsed
Time Frame
18 months
Title
Metformin adherence
Description
Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%)
Time Frame
6 months
Title
Metformin adherence
Description
Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%)
Time Frame
12 months
Title
Metformin adherence
Description
Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%)
Time Frame
18 months
Title
Time to initiation of non-metformin anti-diabetes medication
Description
Time elapsed
Time Frame
18 months
Title
Absolute mean reduction in HbA1c from baseline
Description
Absolute mean reduction in HbA1c from baseline to 6 months following intervention
Time Frame
6 months
Title
Absolute mean reduction in HbA1c from baseline
Description
Absolute mean reduction in HbA1c from baseline to 12 months following intervention
Time Frame
12 months
Title
Absolute mean reduction in HbA1c from baseline
Description
Absolute mean reduction in HbA1c from baseline to 18 months following intervention
Time Frame
18 months
Title
Emergency room visits and hospitalizations post-intervention start
Description
Emergency room visits and hospitalizations within 18 months of intervention start
Time Frame
18 months
Title
Hypoglycemia events post-intervention start
Description
Hypoglycemia events within 18 months of intervention start
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Gilliam, MD, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anjali Gopalan, MD, MS
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Grant, MD, MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Division of Research
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
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