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Proactive Non-Physician Outreach for Type 2 Diabetes

Q: Are there still available positions in this experiment?

In accordance with clinicaltrials.gov, this medical trial is currently not accepting participants. The study was initially posted on September 7th 2022 and the last update occurred October 24th of the same year. However, there are presently 1440 other trials that remain open for enrolment.

Q: What is the anticipated outcome of this experiment?

The primary objective of this extended study is to reduce the HbA1c level below 8% over 18 months. Secondary goals include ensuring patient adherence, as measured by new HbA1c values at follow-up points; and reducing hypoglycemia events and emergency room visits post-intervention start within 18 months.

Q: Are geriatric patients accepted for this medical experiment?

This research project is open to those aged 18-74, with 192 trials specifically for younger participants and 1103 studies dedicated to more senior citizens.

Q: What are the criteria for enrollment in this medical experiment?

This medical trial is enrolling 600 individuals with <a href="https://www.withpower.com/clinical-trials/type-2-diabetes">Type 2 diabetes</a> Mellitus between 18 and 74 years of age. To qualify, a patient must be enrolled in Kaiser Permanente Northern <a href="https://www.withpower.com/clinical-trials/california">California</a> (KPNC), have been diagnosed with incident type-2 diabetes within the last 4 months, receive care from primary care physician (PCP) working in randomized service areas, demonstrate metformin-related therapeutic inertia, and present at least one A1c 6.5 - 7.9 score since diagnosis up to randomization time.

N/A

Waitlist Available

Led By Lisa Gilliam, MD, PhD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Kaiser Permanente Northern California (KPNC) member age 18-74

Incident Type 2 Diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial is looking at whether or not proactive outreach by a non-physician clinician to patients with newly diagnosed Type 2 diabetes can help them better manage their disease.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the interventions involve education and outreach rather than medications, there may not be direct side effects like those associated with drugs; however, participants might experience stress or anxiety from increased engagement about their health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 74 years old and a member of Kaiser Permanente Northern California.

Select...

I have been diagnosed with Type 2 Diabetes recently.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HbA1c<7%

HbA1c<8%

HbA1c<9%

Secondary outcome measures

Absolute mean reduction in HbA1c from baseline

Adherence to HbA1c monitoring

Emergency room visits and hospitalizations post-intervention start

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 3: Physician Education + Accountable Population Manager OutreachExperimental Treatment2 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 EducationExperimental Treatment1 Intervention

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

Group III: Arm 1: Usual CareActive Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Diabetes AssociationOTHER

137 Previous Clinical Trials

98,685 Total Patients Enrolled

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,112,971 Total Patients Enrolled

Lisa Gilliam, MD, PhDPrincipal InvestigatorKaiser Permanente

Media Library

Accountable Population Manager outreach Clinical Trial Eligibility Overview. Trial Name: NCT05566847 — N/A

Type 2 Diabetes Clinical Trial 2023: Accountable Population Manager outreach Highlights & Side Effects. Trial Name: NCT05566847 — N/A

Accountable Population Manager outreach 2023 Treatment Timeline for Medical Study. Trial Name: NCT05566847 — N/A

Type 2 Diabetes Research Study Groups: Arm 1: Usual Care, Arm 2: Physician Education, Arm 3: Physician Education + Accountable Population Manager Outreach

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available positions in this experiment?

"In accordance with clinicaltrials.gov, this medical trial is currently not accepting participants. The study was initially posted on September 7th 2022 and the last update occurred October 24th of the same year. However, there are presently 1440 other trials that remain open for enrolment."

Answered by AI

What is the anticipated outcome of this experiment?

"The primary objective of this extended study is to reduce the HbA1c level below 8% over 18 months. Secondary goals include ensuring patient adherence, as measured by new HbA1c values at follow-up points; and reducing hypoglycemia events and emergency room visits post-intervention start within 18 months."

Answered by AI

Are geriatric patients accepted for this medical experiment?

"This research project is open to those aged 18-74, with 192 trials specifically for younger participants and 1103 studies dedicated to more senior citizens."

Answered by AI

What are the criteria for enrollment in this medical experiment?

"This medical trial is enrolling 600 individuals with Type 2 diabetes Mellitus between 18 and 74 years of age. To qualify, a patient must be enrolled in Kaiser Permanente Northern California (KPNC), have been diagnosed with incident type-2 diabetes within the last 4 months, receive care from primary care physician (PCP) working in randomized service areas, demonstrate metformin-related therapeutic inertia, and present at least one A1c 6.5 - 7.9 score since diagnosis up to randomization time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

2022. "Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05566847.