Clinical trial

Weight Loss Clinical Decision Support

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05198765

Active, not recruitingNot applicableInterventional

What this study is about

Despite steady increases in obesity prevalence, the more than 12 million obese U.S. adults with type 2 diabetes (T2DM) and severe obesity encounter a number of barriers to adopting effective surgical and pharmaceutical treatments, including: (a) both patients and primary care clinicians frequently underestimate the effectiveness and potential benefits of obesity treatments; and (b) both patients and clinicians typically lack access to evidence-based estimates of the patient-specific potential benefits and risks of appropriate obesity treatment options. This project addresses these important obstacles to evidence-based obesity care by providing accurate, patient-specific estimates of benefits and risks of various obesity treatment options to inform shared decision making about obesity treatment. In this project the study team will implement a scalable, web-based point-of-care decision-support intervention in primary care that provides patient-specific estimates of obesity treatment benefits and risks in a randomized trial in 40 primary care clinics with 15,810 eligible patients, and assess intervention impact on (i) appropriate active management of obesity in eligible patients, (ii) weight trajectories, and (iii) patient and clinician satisfaction with the decision support intervention.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionDiabetes Mellitus, Type 2, Obesity

Full registry criteria

Inclusion Criteria: * Adults (age 18-75 years at index clinical encounter) * Existing diagnosis of T2DM * BMI ≥35 kg/m2 at index clinical encounter * Have an index clinical encounter with a PCC (family practice or general internal medicine physician, nurse practitioner, or physician assistant) at a randomized study clinic during a 12-month accrual period Exclusion Criteria: * Prior MBS * Patients diagnosed with cancer (except non-melanoma skin cancer), dementia, and/or cirrhosis. * Pregnant or breastfeeding. * In long-term care, palliative care, or hospice care.

Treatments and study arms

BMI-CDS

Behavioral

The BMI-CDS is a sophisticated point of care shared decision support tool for patients with type 2 diabetes and high BMI. The intervention is built on existing point of care clinical decision support system that algorithmically identifies study-eligible patients and deploys patient-specific CDS output at an index visit and updated CDS all subsequent primary care office, video, and phone encounters.

Primary outcomes

Proportion of patients referred to an MBS programWithin 18 months of index visit date

Proportion of study-eligible patients with estimated high benefit from MBS seen in clinics with the BMI-CDS intervention will be more likely than patients seen in usual care clinics to receive a referral to MBS

Number of new prescriptions of an FDA-approved pharmaceutical for obesity managementWithin 18 months of index visit date

Patients seen in clinics with the BMI-CDS intervention will be more likely than patients seen in usual care clinics to receive to receive a new prescription medication for obesity management

Change in weight trajectory during 18-month post-intervention follow-up period18 months following the index visit

The within-patient slope of weight measurements over the 18 months following the index visit will be less positive for those seen in BMI-CDS intervention versus usual care clinics.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

HealthPartners Medical Group🇺🇸 Minneapolis, Minnesota, United States

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