The Integrated Population (I-POP) Health Trial

Study Overview
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Brief Summary
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The primary aim of this study is to determine whether community health worker (CHW) navigation improves outcomes of chronic disease and chronic disease risk factors in a low-income, primarily ethnic minority population when combined with an evidence-based population health model as compared to usual care after 10 months.

Detailed Description
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The I-POP+CHW participants will be paired with a CHW at baseline to assist with navigation for 10-months between health and wellness services in the selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227. Participants will receive a multi-level intervention utilizing the current I-POP Health model that includes: 1) Access to health services (including oral health), 2) Access to clinical prevention services, 3) Access to education and facilities to increase physical activity and improved nutrition choices, and 4) Scheduled visits with CHWs for education and navigation. Individuals will complete study measures at baseline, 6-months, and 10-months. The control group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months (delayed CHW navigation). The current usual care model is outlined below (section 2.3) Participants will complete study measures at baseline, 6-months, and 10-months timepoints. Upon completion of 10-months measures, these individuals will be assigned a CHW and receive delayed navigation.

Official Title
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The Role of Community Health Workers to Reduce Health Disparities Using a Multi-Level Integrated Population Health Intervention

Conditions
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Diabetes, Hypertension, Chronic Kidney Diseases, Obesity, Chronic Disease

Intervention / Treatment
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* Other: Usual Care
* Other: I-POP + CHW navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Ability to alter diet and/or physical activity Willing to participate in a 10-month study Resident of selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227 Not having utilized BSW HWC membership services within the past 12 months Not planning to move outside of the selected zip code area within the next 6 months Exclusion Criteria: Below the age of 18 years Unable or unwilling to alter diet and/or physical activity Not willing to participate in a 10-month study Not resident of local selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227 Currently using or have used BSW HWC membership services within the past 12 months Planning to move outside of the selected zip code area within the next 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Control group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months (delayed CHW navigation). The current usual care model is outlined. Participants will complete study measures at baseline, 6-months, and 10-months timepoints. Upon completion of 10-months measures, these individuals will be assigned a CHW and receive delayed navigation. | Other: Usual Care<br>* The current I-POP health model includes: 1) BSW HWC primary care medical home (for uninsured or Medicare patients), 2)BSW HWC providing diabetes prevention, nutrition education, weight loss, farm stands, physical activity programming (in collaboration with its onsite City of Dallas Park and Recreation Center), 3) BSW HWC programming at community sites in 75210, 4) Referrals to Parkland Hatcher Station clinic that provides health care to Medicaid patients, 5) Referrals between Parkland Hatcher Station and BSW HWC programming, 6) Community improvement in collaboration with Frazier Revitalization Inc. Individuals will have access to resources within our current, ongoing I-POP Health model, but without CHW navigation between BSW HWC and local service providers. Participants will complete follow-up visits for collection of study measures with study personnel at 6- and 10- months. At the end of the 10-month follow-up period, participants receive an assigned CHW and CHW-navigation.<br>|
| Experimental: I-POP CHW Intervention<br>I-POP+CHW participants will be paired with a CHW at baseline to assist with navigation for 10-months between health and wellness services in the selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227. Participants will receive a multi-level intervention utilizing the current I-POP Health model that includes: 1) Access to health services (including oral health), 2) Access to clinical prevention services, 3) Access to education and facilities to increase physical activity and improved nutrition choices, and 4) Scheduled visits with CHWs for education and navigation. Individuals will complete study measures at baseline, 6-months, and 10-months. | Other: I-POP + CHW navigation<br>* Individuals randomized to this condition will be paired with a CHW to assist with navigation of I-POP Health resources at BSW HWC and entities in local zip codes. CHW navigation will occur through monthly one-on-one follow-up visits for a period of 10-months. Participants will complete study visits for collection of data measures at baseline, 6- and 10- month timepoints. Study participation ends with completion of 10-months data measures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allostatic load | A composite score of 10 biomarkers to measure chronic stress and health outcomes. The biomarkers are BMI, waist-to-hip ratio, HDL, TC/HDL ratio, triglycerides, HbA1c, SBP, DBP, C-reactive protein, and cortisol. For each marker a value of 1 will be assigned if that exceed the third quartile except for HDL where a value of 1 will be assigned if lower than first quartile; otherwise a score of zero will be assigned. [scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5] | Baseline | 
| Allostatic load | A composite score of 10 biomarkers to measure chronic stress and health outcomes. The biomarkers are BMI, waist-to-hip ratio, HDL, TC/HDL ratio, triglycerides, HbA1c, SBP, DBP, C-reactive protein, and cortisol. For each marker a value of 1 will be assigned if that exceed the third quartile except for HDL where a value of 1 will be assigned if lower than first quartile; otherwise a score of zero will be assigned. [scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5]. | 6-months | 
| Cortisol | 4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.] | Baseline | 
| Cortisol | 4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.] | 6-months | 
| C-Reactive protein | 4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.] | Baseline | 
| C-Reactive protein | 4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.] | 6-months | 
| Body mass index | Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703 | Baseline | 
| Body mass index | Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703 | 6-months | 
| Body mass index | Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703 | 10-months | 
| Waist - to - Hip ratio | Waist circumference (centimeters) divided by circumference of hips (centimeters) | Baseline | 
| Waist - to - Hip ratio | Waist circumference (centimeters) divided by circumference of hips (centimeters) | 6-months | 
| Waist - to - Hip ratio | Waist circumference (centimeters) divided by circumference of hips (centimeters) | 10-months | 
| HbA1c | Finger stick blood measure (%) | Baseline | 
| HbA1c | Finger stick blood measure (%) | 6-months | 
| HbA1c | Finger stick blood measure (%) | 10-months | 
| Lipids | Finger stick blood measure collected fasting via fingerstick (mg/dL) | Baseline | 
| Lipids | Finger stick blood measure collected fasting via fingerstick (mg/dL) | 6-months | 
| Lipids | Finger stick blood measure collected fasting via fingerstick (mg/dL) | 10-months | 
| Blood pressure | Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg | Baseline | 
| Blood pressure | Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg | 6-months | 
| Blood pressure | Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg | 10-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet | Measured by self report Dietary Screening questionnaire (DSQ). [scale: dietary nutrients will be calculated on a continuous scale based on NHANES guideline. Score: 0 to any positive value. A score above or below the threshold based on 2000 calories per day would indicate worse outcome.] | Baseline | 
| Diet | Measured by self report Dietary Screening questionnaire (DSQ). [scale: dietary nutrients will be calculated on a continuous scale based on NHANES guideline. Score: 0 to any positive value. A score above or below the threshold based on 2000 calories per day would indicate worse outcome.] | 6-months | 
| Diet | Measured by self report Dietary Screening questionnaire (DSQ). [scale: dietary nutrients will be calculated on a continuous scale based on NHANES guideline. Score: 0 to any positive value. A score above or below the threshold based on 2000 calories per day would indicate worse outcome.] | 10-months | 
| Physical activity | Measured by self report questionnaire [type, frequency, and time completed in minutes] | Baseline | 
| Physical activity | Measured by self report questionnaire [type, frequency, and time completed in minutes] | 6-months | 
| Physical activity | Measured by self report questionnaire [type, frequency, and time completed in minutes] | 10-months | 
| Services utilization | Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.] | Baseline | 
| Services utilization | Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.] | 6-months | 
| Services utilization | Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.] | 10-months | 
| Social determinants | Measured by self-report survey | Baseline | 
| Social determinants | Measured by self-report survey | 6-months | 
| Social determinants | Measured by self-report survey | 10-months | 
| Perceived stress | Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0] | Baseline | 
| Perceived stress | Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0] | 6-months | 
| Perceived stress | Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0] | 10-months | 
| Medication use | Measured by self-report survey | Baseline | 
| Medication use | Measured by self-report survey | 6-months | 
| Medication use | Measured by self-report survey | 10-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community Health Worker, Allostatic load, Ethnic minority, Health services delivery