跳至主要内容
临床试验/NCT05198765
NCT05198765进行中(未招募)不适用

Reducing Clinical Inertia in Obesity Management of Diabetes Patients in Primary Care: Cluster-Randomized Trial

HealthPartners Institute1 个研究点 分布在 1 个国家目标入组 10,120 人开始时间: 2023年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
10,120
试验地点
1
主要终点
Proportion of patients referred to an MBS program

研究概览

简要总结

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.

详细描述

Obesity has been steadily increasing in prevalence and now affects more than 4 in 10 U.S. adults, leading to many adverse health outcomes including myocardial infarction, stroke, type 2 diabetes (T2DM), hypertension, sleep apnea, arthritis, and others. Effective surgical, pharmaceutical, and behavioral treatments for obesity are available, and the evidence to support the broad use of these treatments for obesity is very well established. However, active management of obesity defined as prescribing or referring adults with obesity for lifestyle, pharmaceutical, or surgical treatment of obesity, is greatly underused. Major underlying reasons for underutilization of effective obesity treatments include: (a) both patients and primary care clinicians (PCCs) frequently underestimate the effectiveness and potential benefits of obesity treatments; and (b) both patients and clinicians typically lack access to evidence-based, patient-specific estimates of the potential benefits and risks of appropriate patient-specific obesity treatment options.

To address this problem, the study team will integrate externally validated prediction equations that estimate benefits and risk of various obesity treatment options in adults with T2DM into a widely-used and successful clinical decision support system in order to deliver appropriate patient-specific obesity treatment suggestions at the point of care. The team will implement a scalable, web-based point-of-care decision-support intervention in a randomized trial in 40 primary care clinics with 15,810 eligible patients, and assess intervention impact on the following primary outcomes: (a) appropriate referral of eligible patients for evaluation for metabolic bariatric surgery (MBS); (b) appropriate initiation of FDA-approved medications for weight loss; (c) weight trajectories; and (d) patient-reported conversations with their PCC about weight loss and intentions to engage in weight loss. In addition, the study team collect and analyze clinician-reported and patient-reported data to identify factors that may impede or facilitate broad dissemination of this intervention strategy to other care delivery settings.

This innovative project will (a) provide state-of-the-art scientific evidence on obesity treatment to large numbers of obese American adults with T2DM and their PCCs at the point of care; (b) help PCCs identify appropriate patient-specific obesity treatment options; (c) implement in primary care a web-based electronic health record (EHR)-linked obesity treatment clinical decision support model that uses state-of-the-art Health Information Technology (HIT) standards, is broadly scalable, easy to update as evidence changes, and optimized for clear communication of information to patients and PCCs; and (d) improve the clinical return on ongoing massive private and public investments in outpatient health information systems.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

BMI-CDS

Experimental

Clinicians and their patients assigned to intervention clinics will receive shared decision support tools for weight loss management.

干预措施: BMI-CDS (Behavioral)

Usual Care

No Intervention

Clinicians and their patients assigned to control clinics will engage in the usual standard of care.

结局指标

主要结局

Proportion of patients referred to an MBS program

时间窗: Within 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 management

时间窗: Within 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 period

时间窗: 18 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.

次要结局

  • Intentions to engage in weight loss(6 months following index visit)
  • Likelihood of patient conversation with their pcc about weight loss(6 months following index visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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