Team-Based Care for Type 2 Diabetes

(iPATH Trial)

Recruiting at 3 trial locations

Overseen By Suzanne Tamang, PHD, MPhil, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Children, Low diabetes prevalence, others

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

Compensation: Varies

Number of Visits: Unknown

119680 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Sixteen institutions will be selected from a HRSA uniform data system and have data collected for up to 3 years. Eight institutions will begin the iPATH practice transformation during year one, the other eight institutions will begin iPATH in year two. FQHC administrators, clinicians and staff will be enrolled to participate in the iPATH transformation in their clinic and will participate in qualitative interviews. Patient HbA1c data from the clinics will be collected for comparative data analysis during each year of the study.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is team-based care for type 2 diabetes safe for humans?

The research articles reviewed do not provide specific safety data for team-based care for type 2 diabetes or the iPATH implementation approach. However, they highlight the importance of proper training and education for healthcare teams to ensure safe use of diabetes technologies like insulin pumps, which can have risks if not used correctly. ^{1 2 3 4 5}

How is the iPATH implementation approach for type 2 diabetes different from other treatments?

The iPATH implementation approach is unique because it focuses on team-based care, involving a coordinated effort by healthcare professionals to manage type 2 diabetes. This approach emphasizes regular follow-ups, personalized care plans, and ongoing evaluation to improve patient outcomes, which is different from traditional individual-based care. ^{6 7 8 9 10}

What data supports the effectiveness of the iPATH implementation approach for treating type 2 diabetes?

Research shows that team-based care, which involves a group of healthcare professionals working together, can improve blood sugar control and quality of life for people with type 2 diabetes. This approach has been effective in various settings, suggesting that the iPATH implementation could also be beneficial. ^{6 7 11 12 13}

Are You a Good Fit for This Trial?

The iPATH trial is for the two largest clinic sites within multi-clinic FQHCs located in or near Massachusetts, Ohio, California, and Puerto Rico. These clinics should be performing in the mid-range for diabetes control (3rd quartile) with adult patients having poorly controlled diabetes.

Inclusion Criteria

Organizations included will be the two largest clinic sites in multi-clinic FQHCs operating in or near Massachusetts, Ohio, California, Puerto Rico, performing in the 3rd quartile for percentage of patients with poorly controlled diabetes (A1c>9%)

Exclusion Criteria

Exclude FQHCs that have a patient population comprised of more than 80% children

Exclude FQHCs that have a patient population multiplied by the FQHC's diabetes prevalence in the lowest 10% of all the clinics

Exclude FQHCs that have fewer than 5,000 or more than 50,000 patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the iPATH practice transformation strategy at FQHCs

1 year

Ongoing visits as part of practice transformation

Evaluation

Comprehensive evaluation of the iPATH implementation approach using a hybrid type 2 study

1 year

Follow-up

Participants are monitored for safety and effectiveness after practice transformation

1 year

What Are the Treatments Tested in This Trial?

Interventions

• iPATH implementation approach

Trial Overview iPATH aims to improve type 2 diabetes care by refining a practice transformation approach at FQHCs. It involves identifying effective organizational processes pre- and post-pandemic, implementing technology-enabled strategies tailored to each clinic's needs, and evaluating these changes using a hybrid study design.

How Is the Trial Designed?

Group I: Wave 2 Clinics Experimental Treatment 1 Intervention

Clinics will have data evaluated for up to 3 years. Wave 2 clinics will begin the iPATH practice transformation in Year 2.

Group II: Wave 1 Clinics Experimental Treatment 1 Intervention

Clinics will have data evaluated for up to 3 years. Wave 1 clinics will begin the iPATH practice transformation in Year 1.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Impactivo, LLC.

Collaborator

Trials

1

Recruited

120,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The study reviewed 15 articles out of 6435 identified, focusing on the effectiveness of the IHI Outpatient Adverse Event Trigger Tool in detecting preventable adverse events (pAEs) in primary care, with medication errors being the most common pAE identified.

Results showed that the effectiveness of the IHI Tool in identifying adverse events varied significantly, indicating a need for improved detection methods and further research to enhance patient safety in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Accuracy of Trigger Tools to Detect Preventable Adverse Events in Primary Care: A Systematic Review. Davis, J., Harrington, N., Bittner Fagan, H., et al.[2019]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The use of a multidisciplinary team care approach to improve glycemic control and quality of life by the prevention of complications among diabetic patients. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Team-based multicomponent care improved and sustained glycaemic control in obese people with type 2 diabetes (T2D) in a Diabetes Centre setting: A quality improvement program with quasi-experimental design. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of telephone-based peer support in patients with type 2 diabetes mellitus receiving integrated care: a randomized clinical trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Team-Based Diabetes Care in Ontario and Hong Kong: a Comparative Review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Influence of an interdisciplinary diabetes specialist team on short-term outcomes of diabetes at a community health center. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Facilitators and Barriers to Smart Insulin Pen Use: A Mixed-Method Study of Multidisciplinary Stakeholders From Diabetes Teams in the United States. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Accuracy of Trigger Tools to Detect Preventable Adverse Events in Primary Care: A Systematic Review. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evolution of a diabetes inpatient safety committee. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Medical Home Characteristics and Quality of Diabetes Care in Safety Net Clinics. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Structuring and organizing interprofessional healthcare in partnership with patients with diabetes: the INterprofessional Management and Education in Diabetes care (INMED) pathway. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Measurement of Pharmacist-Physician Collaborative Care on Therapeutic Inertia in Patients With Type 2 Diabetes. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Interprofessional care of patients with type 2 diabetes mellitus in primary care: family physicians' perspectives. [2022]