Coordinating Pragmatic Primary Care Population Management for Obesity

Study Overview
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Brief Summary
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The C3PO pilot and feasibility study uses a rigorous, mixed-method research design to provide information needed to refine and implement a technology-mediated primary care outreach intervention approach before conducting a larger and more definitive future intervention trial.

Detailed Description
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This study will implement and evaluate a pragmatic and generalizable framework for population management of obesity by the primary care sector. With patient and other stakeholder input, the C3PO intervention will be designed to leverage existing primary care professionals and technologies to implement a scalable framework for population obesity management that coordinates primary care services with extant intensive lifestyle interventions in community settings to achieve wider reach and population-level effectiveness. A rigorous, mixed-method pilot and feasibility study will provide critical information needed to optimize the intervention design and prepare us for a larger and definitive future trial.

Official Title
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Coordinating Pragmatic Primary Care Population Management for Obesity

Conditions
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Obesity, Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing
* Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions
* Behavioral: Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 27 kg/m2 ≥ 1 CVD risk condition (hypertension, dyslipidemia, prediabetes or type 2 diabetes) Registered in Northwestern Medical Group's EpicCare MyChart patient portal Received and completed MyChart survey of weight loss interest Affirms interest in weight loss goal setting and receiving additional resource information and electronic Scale. Exclusion Criteria: Evidence of hospitalization in past 30 days Most recent blood pressure >180/105 Cancer (non-skin) treatment within the past 2 years Encounter diagnosis for hypoglycemia in past 30 days Actively receiving care from the bariatric surgery service or a bariatric medication order in the past 100 days

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Interventional Model Description: The active intervention C3PO involves enhanced use of pragmatic electronic health record system technologies and members of the primary care workforce to increase supportive accountability and problem solving support for weight loss goals and behavior, which in turn will lead to routine self-weighing, increased take up into intensive community programs, and increased adoption and maintenance of healthy eating and physical activity behaviors that collectively lead to greater weight loss at a population level.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Basic Resources and Services<br>Patients will receive outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community | Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing<br>* Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning. Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.<br>Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions<br>* Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community. Patients who request information or clinical referrals will also receive them. Refreshes of community linkage information will be sent by MyChart every 1 to 4 weeks.<br>|
| Experimental: Coordinated Primary Care Population Management (C3PO)<br>Patients will receive outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success. | Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing<br>* Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning. Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.<br>Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions<br>* Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community. Patients who request information or clinical referrals will also receive them. Refreshes of community linkage information will be sent by MyChart every 1 to 4 weeks.<br>Behavioral: Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support<br>* Data received into the electronic health record from the cellular network-enabled electronic scale will categorize each patient based on their daily self-weighing behaviors and rate of progress towards their weight loss goal. Patients who are not engaged in daily self-weighing or are not making progress towards their goal will receive more intensive outreach support in the form of automated weekly MyChart problem solving messages, more frequent encouragement to access a broader array of community resources, and telephonic support from a nurse care coordinator who is an existing member of the primary care team. Support from this nurse care coordinator will be facilitated by the incorporation of each patient's self-weighing data into an EpicCare patient dashboard accessible to the nurse coordinator and other members of the care team<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months | Proportion of Participants who Reach a 5% Weight Loss Goal at 6 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 6 months (kg))/(Baseline body mass (kg)) | Baseline - 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs to Implement the Intervention | Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components | Baseline - 12 Months | 
| Change in Hemoglobin A1C | Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months | Baseline - 12 Months | 
| Change in Systolic Blood Pressure | Mean change in systolic blood pressure (mmHg) from baseline to 12 months | Baseline - 12 Months | 
| Change in Total Cholesterol | Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months | Baseline - 12 Months | 
| Change in Non-HDL Cholesterol | Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months | Baseline - 12 Months | 
| Body Mass Change at 6 Months | Mean Change in Body Mass (kg) from Baseline to 6 Months | Baseline - 6 Months | 
| Body Mass Change at 12 Months | Mean Change in Body Mass (kg) from Baseline to 12 Months | Baseline - 12 Months | 
| Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months | Proportion of Participants who Reach a 5% Weight Loss Goal at 12 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 12 months (kg))/(Baseline body mass (kg)) | Baseline - 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obesity, prediabetes, type 2 diabetes, hypertension, dyslipidemia, cardiovascular risk factor, adult, primary care