What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include lifestyle modifications, oral glucose-lowering drugs, insulin, SGLT2 inhibitors, and GLP1 receptor agonists. Lifestyle modifications generally have minimal side effects but can be challenging to maintain. Oral glucose-lowering drugs like metformin may cause gastrointestinal issues such as nausea and diarrhea. Insulin therapy can lead to weight gain and hypoglycemia. SGLT2 inhibitors are associated with an increased risk of urinary tract infections and, in some cases, amputations. GLP1 receptor agonists may cause gastrointestinal symptoms like nausea and vomiting and have been linked to a reduced risk of cardiovascular events. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs and risks.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes, including metformin, which is often used as the first-line therapy. GLP-1 receptor agonists such as exenatide (Bydureon BCise) and dulaglutide have also been approved, with exenatide being specifically approved for pediatric use. Insulin remains a critical treatment option, particularly for patients with persistent hyperglycemia despite oral medications. These treatments align with the goals of Clinical Decision Support Tools, which aim to enhance diabetes management by incorporating social risk factors into care plans.

What other types of research exist?

Promising, novel alternatives to Clinical Decision Support Tools for Type 2 Diabetes patients in 2024 include telemedicine for remote monitoring and consultations, personalized medicine that tailors treatment based on individual genetic and lifestyle factors, and advanced pharmacological treatments such as new drug combinations and therapies.

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CDS Tool Access for High Blood Pressure (COHERE Trial)

N/A

Waitlist Available

Led By Rachel Gold, PhD, MPH

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests digital tools that help doctors consider patients' social challenges when planning care. It focuses on patients at community health centers who have been screened for social risks. The goal is to improve health outcomes by adjusting care plans based on these social factors.

Who is the study for?

This trial is for clinics that joined OCHIN by July 1, 2021, have done over 200 social risk screenings in the past year, and provide primary care. Clinics that took part in the pilot study, serve prison populations or are school-based health centers cannot participate.

What is being tested?

The COHERE study is testing a new tool called CDS which shows patient's social risks to healthcare teams so they can adjust treatment plans. The goal is to see if this leads to better control of high blood pressure and type 2 diabetes.

What are the potential side effects?

Since this trial involves a decision support tool rather than medication, there aren't direct physical side effects like with drugs. However, there may be impacts on clinic workflow or data management processes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

diabetes control

hypertension control

Secondary study objectives

SDH z-codes added to problem list and/or visit list

completion of medication adherence documentation

completion of social risk screening

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

Intervention clinics will have the CDS tools turned on in their EHR.

Group II: Control ArmActive Control1 Intervention

Control clinics will not receive an intervention.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 2 Diabetes include lifestyle interventions, oral medications, and injectable therapies. Lifestyle interventions, such as diet and exercise, improve insulin sensitivity and glycemic control. Oral medications like metformin reduce hepatic glucose production and increase insulin sensitivity, while sulfonylureas stimulate insulin secretion from the pancreas. Injectable therapies, including insulin and GLP-1 receptor agonists, help regulate blood glucose levels by enhancing insulin secretion and slowing gastric emptying. These treatments are crucial for managing Type 2 Diabetes as they address different aspects of the disease's pathophysiology. Clinical Decision Support tools that incorporate social risk information can further tailor these treatments to individual patient needs, potentially improving adherence and outcomes by considering factors like socioeconomic status, access to healthcare, and lifestyle challenges.

Development and Evaluation of a Prediabetes Decision Aid in Primary Care: Examining Patient-Reported Outcomes by Language Preference and Educational Attainment.Behavioural interventions for type 2 diabetes: an evidence-based analysis.