Proactive Non-Physician Outreach for Type 2 Diabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Preceding T2D, Pregnant, Type 1 diabetes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether proactive outreach by a non-physician clinician, known as an Accountable Population Manager (APM), can help individuals with newly diagnosed Type 2 diabetes better manage their blood sugar levels. The researchers aim to determine if this outreach is more effective than typical care or physician education alone. The goal is to assess whether this approach helps patients achieve their blood sugar targets six months after starting the program. Individuals recently diagnosed with Type 2 diabetes who have not yet started metformin (a common diabetes medication) may be suitable candidates, particularly if their blood sugar levels are slightly elevated. As an unphased trial, this study provides a unique opportunity to explore innovative care strategies that could enhance diabetes management.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on proactive outreach for managing Type 2 diabetes, so it's best to discuss your current medications with the trial coordinators.

What prior data suggests that the Accountable Population Manager outreach and Physician Education are safe for patients with Type 2 Diabetes?

Research shows that patients generally respond well when an Accountable Population Manager (APM) reaches out to them. A trial program found that this outreach led to positive outcomes, such as increased screenings for diabetes-related issues like nerve damage. This approach is safe and beneficial for patients.

For educating doctors, studies have shown that similar programs can lead to safer prescribing practices and better blood sugar control in patients. These results indicate that the programs are safe and effective, with no major negative effects reported.

Overall, research considers both the APM outreach and doctor education methods safe. They aim to improve diabetes care without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring new ways to manage Type 2 Diabetes beyond traditional medication or lifestyle changes. While usual care involves managing glucose levels with medications like Metformin and lifestyle interventions, this trial is testing the impact of proactive outreach and physician education. The unique feature of this approach is the involvement of an Accountable Population Manager (APM) who actively engages with patients to address therapeutic inertia, which is when treatment adjustments are delayed. This kind of proactive, personalized outreach could lead to more timely treatment adjustments and better long-term health outcomes for patients.

What evidence suggests that this trial's treatments could be effective for Type 2 diabetes?

Research has shown that educating doctors can greatly improve the management of Type 2 diabetes. One study demonstrated that doctors who participated in structured educational programs helped reduce their patients' blood sugar levels by 37%. Another study found that teaching doctors improved diabetes care in 71 hospitals in China. In this trial, some participants will be in the Physician Education arm, where physicians receive targeted educational sessions.

For the Accountable Population Manager (APM) outreach, research suggests this method can improve the quality of diabetes care and lower the risk of complications. Strategies like APM outreach have been linked to better health outcomes and fewer diabetes-related problems. In this trial, participants in the Physician Education + APM Outreach arm may receive proactive outreach from an APM. These findings are promising for both methods in enhancing diabetes care. ^{1 2 6 7 8}

Who Is on the Research Team?

Lisa Gilliam, MD, PhD

Principal Investigator

Kaiser Permanente

Richard Grant, MD, MPH

Principal Investigator

Kaiser Permanente

Anjali Gopalan, MD, MS

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for adults aged 18-74 who are members of Kaiser Permanente Northern California, have recently been diagnosed with Type 2 Diabetes, and haven't started on metformin despite having an A1c level between 6.5-7.9%. Pregnant individuals or those likely to have Type 1 diabetes, or a previous diagnosis of T2D are excluded.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes recently.

Patient of primary care physician (PCP) working in the randomized service areas

My diabetes treatment with metformin hasn't changed despite needing adjustment.

Exclusion Criteria

I am likely to have Type 1 diabetes.

I have been diagnosed with type 2 diabetes.

You were pregnant when you were diagnosed with type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive proactive outreach by an Accountable Population Manager (APM) and/or physician education on therapeutic inertia

6 months

Regular visits as per standard diabetes care

Follow-up

Participants are monitored for glycemic targets and other outcomes post-intervention

18 months

Regular follow-up visits for HbA1c monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Accountable Population Manager outreach
• Physician Education

Trial Overview The study tests if proactive outreach by non-physician clinicians (Accountable Population Managers) can help patients newly diagnosed with Type 2 Diabetes start treatment early and reach blood sugar targets within six months.

How Is the Trial Designed?

Group I: Arm 3: Physician Education + Accountable Population Manager Outreach Experimental Treatment 2 Interventions

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 II: Arm 2: Physician Education Experimental Treatment 1 Intervention

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

Group III: Arm 1: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/show/NCT05566847

Overcoming Therapeutic Inertia Among Adults Recently ... This project aims to evaluate the effects of proactive outreach by a non-physician clinician (Accountable Population Manager [APM]) to patients with newly ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8438798/

Outreach Method Predicts Patient Re-engagement in ... This study was designed to determine how outreach influences patients to maintain diabetes care and identify factors that might impact the intervention's ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5536329/

Population Health Management for Diabetes Population care approaches for diabetes have the potential to improve the quality of care and decrease diabetes-related mortality and morbidity.

4. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S14/157553/1-Improving-Care-and-Promoting-Health-in

1. Improving Care and Promoting Health in Populations Several models have been demonstrated to improve aspects of diabetes care delivery and health outcomes. The Chronic Care Model (CCM) is a ...

5. ajmc.com ajmc.com/view/stakeholder-insights-on-rtcgm-in-t2d-population-health-management

Stakeholder Insights on rtCGM in T2D Population Health ... In terms of return on investment, rtCGM has demonstrated real-world cost savings in T2D in prospective and retrospective analyses due to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10725798/

1. Improving Care and Promoting Health in Populations Additionally, the risk for type 2 diabetes is increased twofold in those with food insecurity (89) and has been associated with lower engagement in self-care ...

7. diabetesjournals.org diabetesjournals.org/care/article/47/8/1299/156804/The-Final-Frontier-in-Diabetes-Care-Implementing

The Final Frontier in Diabetes Care: Implementing Research ... An analysis of U.S. nationally representative, population-based data from the 2016 and 2017 National Health Interview Surveys, involving 50,912 ...

8. researchgate.net researchgate.net/publication/380738992_Outcomes_of_a_Pilot_Outreach_Program_to_Support_Point-of-Care_Screening_in_Individuals_with_Diabetes_who_are_Experiencing_Homelessness_in_Alberta_Canada

(PDF) Outcomes of a Pilot Outreach Program to Support ... Results Compared to the previous two years, participants (n = 40) experienced a 2.9-fold increase in peripheral neuropathy screening; a 1.7-fold ...