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Type 2 DiabetesNCT05566847

Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes

A study testing Physician Education and Accountable Population Manager outreach in people with Type 2 Diabetes, run by Kaiser Permanente at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Physician Education and Accountable Population Manager outreach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
817 participants
Where
1 siteUnited States
Study dates
7 Sep 2022to 31 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kaiser Permanente Division of Research

    Oakland, California, 94612

Other trials in United States

About this study

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.

Read the 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.

Conditions
Type 2 Diabetes
Being tested
Physician Education, Accountable Population Manager outreach
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physician EducationOther

    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.

  • Accountable Population Manager outreachOther

    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.

Study groups in NCT05566847
Study groupRoleWhat they receive
Arm 1: Usual CareNo interventionParticipants will receive standard care for newly diagnosed Type 2 Diabetes.
Arm 2: Physician EducationExperimentalPhysicians in service areas randomized to this arm were invited to a physician education session on therapeutic inertia.
Receives: Other: Physician Education
Arm 3: Physician Education + Accountable Population Manager OutreachExperimentalPhysicians 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).
Receives: Other: Physician Education; Other: Accountable Population Manager outreach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c<7%

    Proportion of patients with HbA1c less than 7% at 6 months following the start of the intervention.

    Measured: 6 months

  2. HbA1c<7%

    Proportion of patients with HbA1c less than 7% at 12 months following the start of the intervention.

    Measured: 12 months

  3. HbA1c<7%

    Proportion of patients with HbA1c less than 7% at 18 months following the start of the .intervention.

    Measured: 18 months

  4. HbA1c<8%

    Proportion of patients with HbA1c less than 8% at 6 months following the start of the intervention.

    Measured: 6 months

  5. HbA1c<8%

    Proportion of patients with HbA1c less than 8% at 12 months following the start of the intervention.

    Measured: 12 months

  6. HbA1c<8%

    Proportion of patients with HbA1c less than 8% at 18 months following the start of the intervention.

    Measured: 18 months

  7. HbA1c<9%

    Proportion of patients with HbA1c less than 9% at 6 months following the start of the intervention.

    Measured: 6 months

  8. HbA1c<9%

    Proportion of patients with HbA1c less than 9% at 12 months following the start of the intervention.

    Measured: 12 months

  9. HbA1c<9%

    Proportion of patients with HbA1c less than 9% at 18 months following the start of the intervention.

    Measured: 18 months

Secondary outcomes (14)

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

    Time elapsed

    Measured: 18 months

  2. Adherence to HbA1c monitoring

    New HbA1c value at follow-up time points

    Measured: 6 months

  3. Adherence to HbA1c monitoring

    New HbA1c value at follow-up time points

    Measured: 12 months

  4. Adherence to HbA1c monitoring

    New HbA1c value at follow-up time points

    Measured: 18 months

  5. Time to metformin initiation

    Time elapsed

    Measured: 18 months

  6. Metformin adherence

    Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%)

    Measured: 6 months

  7. Metformin adherence

    Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%)

    Measured: 12 months

  8. Metformin adherence

    Among those initiated on metformin, adherence to medication (proportion days covered, ≥80% vs. <80%)

    Measured: 18 months

  9. Time to initiation of non-metformin anti-diabetes medication

    Time elapsed

    Measured: 18 months

  10. Absolute mean reduction in HbA1c from baseline

    Absolute mean reduction in HbA1c from baseline to 6 months following intervention

    Measured: 6 months

  11. Absolute mean reduction in HbA1c from baseline

    Absolute mean reduction in HbA1c from baseline to 12 months following intervention

    Measured: 12 months

  12. Absolute mean reduction in HbA1c from baseline

    Absolute mean reduction in HbA1c from baseline to 18 months following intervention

    Measured: 18 months

  13. Emergency room visits and hospitalizations post-intervention start

    Emergency room visits and hospitalizations within 18 months of intervention start

    Measured: 18 months

  14. Hypoglycemia events post-intervention start

    Hypoglycemia events within 18 months of intervention start

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start7 Sep 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
817 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05566847
Sponsor's protocol ID
12-21-OTI-02
Status last verified
Jan 2024
First submitted
21 Sep 2022
Last updated
25 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Physician Education and Accountable Population Manager outreach in people with Type 2 Diabetes, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c<7% (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05566847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.

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