PATHWEIGH: Pragmatic Weight Management in Primary Care

Study Overview
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Brief Summary
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The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. This will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews.

Detailed Description
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This study will investigate how PATHWEIGH, a weight management tool built into the EPIC electronic health record, in combination with clinician and staff training on the use of PATHWEIGH as a tool, education on effective weight management practices, and practice facilitation to support implementation can facilitate weight loss and maintenance for primary care patients. The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. This will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews. This study is being conducted because despite obesity being the leading cause of preventable death in the U.S. and a major risk factor for disease, people with any degree of overweight or obesity are rarely offered anything other than lifestyle advice, rather than more rigorous and evidence-based weight management strategies. Poor reimbursement for weight-related visits, competing priorities, lack of appropriate tools, and limited time in visits also prevent more widespread use of weight management interventions. PATHWEIGH helps primary care clinicians and teams prioritize weight management with their patients when appropriate and ensures that they have the tools and knowledge handy to do so effectively. As part of the assessment of the PATHWEIGH intervention, the study will identify predictors of patient weight loss and weight loss maintenance using mediator and moderator analysis. Relevant factors (patient demographics, health metrics (e.g. vital signs, anthropometrics, comorbidities), behaviors and goals, provider age, sex, years and % time practicing, and clinic information (e.g. size, location, culture scale)) will be evaluated by including interaction terms between the treatment variable and possible moderating variables in outcome regression models .

Official Title
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PATHWEIGH: Pragmatic Weight Management in Primary Care

Conditions
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Obesity

Intervention / Treatment
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* Other: Weight management care path
* Other: Control


Participation Criteria
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Eligibility Criteria
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Clinician Inclusion Criteria: Affiliated with a participating primary care practice Provide care for adult patients (>=18 years old) Patient Inclusion Criteria: All adult patients (age >18 years) BMI >25 kg/m2 Appointment at a primary care clinic participating in the study Patient Exclusion Criteria: Unable to participate in weight loss treatment due to factors such as cognitive deficits, non-home residence, or limited life expectancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Effectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Each primary care provider will administer weight loss care per their standard practice. | Other: Control<br>* Within primary care the option to select Obesity brief HPI, this is a brief historical intake of a patient's weight - when either they or their clinician decides to have a weight-prioritized visit. It is intended to initiate a discussion regarding potential strategies for weight loss (often eat less, exercise more). The provider has the discretion to augment or add support as they see fit.<br>|
| Experimental: PATHWEIGH<br>A weight management care path that support primary care both through the EHR and training for the clinicians. | Other: Weight management care path<br>* Documentation and data capture built in the Electronic Health Record Clinical data support that suggests weight loss approach(es) Tracking of weight loss progress and weight loss maintenance during patient visits to guide the patient-clinician conversation Diagnosis and billing in EHR automatically adds the diagnosis of overweight or obesity and links the most common weight-related co-morbidities to ensure adequate provider reimbursement Evidence-based online training on weight management for clinicians Practice quality improvement and training for use of PATHWEIGH for weight-prioritized visits through practice coaches/facilitators Consultation support by practice facilitators with implementing PATHWEIGH and by obesity providers for clinicians with creating patient treatment plans<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the implementation of PATHWEIGH and determine its effectiveness versus control clinics using standard of care (SOC) on patient weight loss | Change from baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the implementation of PATHWEIGH and determine its effectiveness versus standard of care on weight loss maintenance. | To examine weight maintenance we will examine weight change from 6 to 12 months and 6 to 18 months. Weight loss maintenance will be defined as weight increase <10% from the 6-month weight time point. | 12 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Primary Care, Electronic Health Record