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出境医 / 临床实验 / Coordinating Pragmatic Primary Care Population Management for Obesity (C3PO)

Coordinating Pragmatic Primary Care Population Management for Obesity (C3PO)

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Cardiovascular Risk Factor 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 Not Applicable

Detailed Description:
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: Patients will be randomized to either Basic Resources and Services or the C3PO intervention arm. Although patients will be aware of the specific forms of support they are receiving throughout the trial, each individual will not be aware that they are part of a randomized experiment and will not know that other patients may be receiving different levels of support. For this reason, the non-concealed nature of the behavioral support intervention for participating patients should not introduce bias. Investigators and outcome assessors will not be aware of intervention assignment during the study conduct or evaluation phase.
Primary Purpose: Health Services Research
Official Title: Coordinating Pragmatic Primary Care Population Management for Obesity
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : October 30, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Basic Resources and Services
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
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.

Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions
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.
Experimental: Coordinated Primary Care Population Management (C3PO)
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
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.

Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions
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.

Behavioral: Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support
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
Outcome Measures
Primary Outcome Measures :
  1. Achieve 5% Weight Loss Goal at 6 Months [ Time Frame: 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))


Secondary Outcome Measures :
  1. Costs to Implement the Intervention [ Time Frame: 12 Months ]
    Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components

  2. Change in Hemoglobin A1C [ Time Frame: 12 Months ]
    Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months

  3. Change in Systolic Blood Pressure [ Time Frame: 12 Months ]
    Mean change in systolic blood pressure (mmHg) from baseline to 12 months

  4. Change in Total Cholesterol [ Time Frame: 12 Months ]
    Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months

  5. Change in Non-HDL Cholesterol [ Time Frame: 12 Months ]
    Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months

  6. Body Mass Change at 6 Months [ Time Frame: 6 Months ]
    Mean Change in Body Mass (kg) from Baseline to 6 Months

  7. Body Mass Change at 12 Months [ Time Frame: 12 Months ]
    Mean Change in Body Mass (kg) from Baseline to 12 Months

  8. Achieve 5% Weight Loss Goal in 12 Months [ Time Frame: 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))


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ronald Ackermann, MD, MPH 312.503.6400 r.ackermann@northwestern.edu
Contact: Cassandra Aikman, MPH 312.503.3019 cassandra.aikman@northwestern.edu

Sponsors and Collaborators
Northwestern University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date June 25, 2019
Estimated Study Start Date  ICMJE August 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019) 		Achieve 5% Weight Loss Goal at 6 Months [ Time Frame: 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))
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Costs to Implement the Intervention [ Time Frame: 12 Months ]
    Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
  • Change in Hemoglobin A1C [ Time Frame: 12 Months ]
    Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
  • Change in Systolic Blood Pressure [ Time Frame: 12 Months ]
    Mean change in systolic blood pressure (mmHg) from baseline to 12 months
  • Change in Total Cholesterol [ Time Frame: 12 Months ]
    Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
  • Change in Non-HDL Cholesterol [ Time Frame: 12 Months ]
    Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
  • Body Mass Change at 6 Months [ Time Frame: 6 Months ]
    Mean Change in Body Mass (kg) from Baseline to 6 Months
  • Body Mass Change at 12 Months [ Time Frame: 12 Months ]
    Mean Change in Body Mass (kg) from Baseline to 12 Months
  • Achieve 5% Weight Loss Goal in 12 Months [ Time Frame: 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))
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coordinating Pragmatic Primary Care Population Management for Obesity
Official Title  ICMJE Coordinating Pragmatic Primary Care Population Management for Obesity
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description:
Patients will be randomized to either Basic Resources and Services or the C3PO intervention arm. Although patients will be aware of the specific forms of support they are receiving throughout the trial, each individual will not be aware that they are part of a randomized experiment and will not know that other patients may be receiving different levels of support. For this reason, the non-concealed nature of the behavioral support intervention for participating patients should not introduce bias. Investigators and outcome assessors will not be aware of intervention assignment during the study conduct or evaluation phase.
Primary Purpose: Health Services Research
Condition  ICMJE
  • Obesity
  • Cardiovascular Risk Factor
Intervention  ICMJE
  • Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing
    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.
  • Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions
    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.
  • Behavioral: Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support
    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
Study Arms  ICMJE
  • Active Comparator: Basic Resources and Services
    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
    Interventions:
    • Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing
    • Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions
  • Experimental: Coordinated Primary Care Population Management (C3PO)
    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.
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998046
Other Study ID Numbers  ICMJE STU00207153
R34DK114773 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ronald Ackermann, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE Not Provided
PRS Account Northwestern University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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