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Study the Impact of the CommunityRx Program on Health, Self-care and Cost

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435511
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : May 15, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
CommunityRx is a health information technology-based innovation that, starting with the patient-health care provider encounter, facilitates self-care coordination for patients, caregivers, and providers. The CommunityRx database interfaces with electronic medical records to provide patients with a "HealtheRx." A HealtheRx is a list of community-based self-care resources tailored to the patients health needs (e.g., a person with diabetes receives information about podiatrists, nutrition classes, and other resources need to manage diabetes). CommunityRx aims to measurably improve health and health care while reducing health care costs especially in underserved health care settings. Specifically, the proposed research aims to 1) evaluate the impact of CommunityRx on health care utilization, cost, health, and patient-centered outcomes for program participants compared to controls; 2) examine the flow and spread of information to and through primary agents including: program participants, community health information experts, healthcare providers, and community-based service providers (businesses and organizations providing self-care resources); and 3) build and use an agent-based model to test the distributed impact, including economic effects, of CommunityRx system adoption on the demonstration area and predict performance over time by conducting experiments that vary assumptions about agent, environment, and population-level characteristics.

Condition or disease Intervention/treatment Phase
Health Behavior Other: HealtheRx Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 411 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating CommunityRx, a Self-Care Innovation for Older Adults, Using Agent-Based Modeling: Collecting and Analyzing Data to Build the Agent Based Model
Actual Study Start Date : December 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2017

Arm Intervention/treatment
No Intervention: Control arm
The control group will receive usual care, no HealtheRx.
Experimental: Intervention arm
The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs.
Other: HealtheRx
The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient.




Primary Outcome Measures :
  1. Mental Health-related Quality of Life at 3 Months [ Time Frame: Assessed at Baseline, 1 Week, 1 Month and 3 Months; score at 3 months reported ]
    Health-related quality of life will be measured using the Short Form Health Survey (SF-12) . Minimum value=0, maximum value=100. Higher scores equal better mental health.


Secondary Outcome Measures :
  1. Change From Baseline in Cost Effectiveness at 3 Months [ Time Frame: Baseline, 3 months ]
    Using claims data and self-reported data on heath care utilization, we will use data from intervention baseline and at 3 months following the intervention to assess the cost effectiveness of HealtheRx.

  2. Patient Satisfaction at 3 Months [ Time Frame: Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported here ]
    Patient satisfaction will be measures using the domain of general satisfaction from the Patient Satisfaction Questionnaire (PSQ-18)

  3. Physical Health-related Quality of Life at 3 Months [ Time Frame: Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported ]
    Health-related quality of life will be measured using the Short Form-12 (SF-12). Minimum value=0, maximum value=100. Higher scores equal better physical health.

  4. Self-efficacy - Finding Places and Services in Community to Manage Health as Measured by Questionnaire [ Time Frame: Assessed at baseline, 1 week, 1 month and 3 months; score at 3 months reported ]
    Measure confidence in ability to find services to take care of health


Other Outcome Measures:
  1. Access to Resources - Weight Loss Class or Support Group as Measured by Questionnaire Developed for This Study [ Time Frame: Baseline, 1 week, 1 month and 3 months ]
    Measure perceived and self-reported access to weight loss classes or support groups

  2. Access to Resources - Healthy Eating Classes as Measured by Questionnaire Developed for This Study [ Time Frame: Baseline, 1 week, 1 month and 3 months ]
    Measure perceived and self-reported access to health eating classes

  3. Access to Resources - Counseling as Measured by Questionnaire Developed for This Study [ Time Frame: Baseline, 1 week, 1 month and 3 months ]
    Measure perceived and self-reported access to counseling

  4. Access to Resources - Smoking Cessation Classes as Measured by Questionnaire Developed for This Study [ Time Frame: Baseline, 1 week, 1 month and 3 months ]
    Measure perceived and self-reported access to smoking cessation classes

  5. Access to Resources - Stress Management Classes as Measured by Questionnaire Developed for This Study [ Time Frame: Baseline, 1 week, 1 month and 3 months ]
    Measure perceived and self-reported access to stress management classes

  6. Access to Resources - Rent/Mortgage as Measured by Questionnaire Developed for This Study [ Time Frame: Baseline, 1 week, 1 month and 3 months ]
    Measure perceived and self-reported access to help paying rent or mortgage

  7. Self-efficacy - Smoking Cessation as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale [ Time Frame: Baseline, 1 week, 1 month and 3 months ]
    Measure confidence in ability to quit smoking

  8. Self-efficacy - Weight as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale [ Time Frame: Baseline, 1 week, 1 month and 3 months ]
    Measure confidence in ability to manage weight

  9. Self-efficacy - Eating Healthy as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale [ Time Frame: Baseline, 1 week, 1 month and 3 months ]
    Measure confidence in ability to eat healthy

  10. Self-efficacy - Exercise as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale [ Time Frame: Baseline, 1 week, 1 month and 3 months ]
    Measure confidence in ability to exercise



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 45-74 years old
  • Medicaid and/or Medicare beneficiary
  • Living in 1 of the 16 zip codes served by CommunityRx
  • Seen at University of Chicago primary care or emergency department

Exclusion Criteria:

  • Recollection of previous receipt of a HealtheRx

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435511


Locations
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United States, Illinois
University of Chicago Medicine - Adult Emergency Department and Primary Care Group clinic
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Stacy T Lindau, MD, MAPP University of Chicago
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02435511    
Other Study ID Numbers: 1R01AG047869-01 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2015    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: October 11, 2019
Last Verified: September 2019
Keywords provided by University of Chicago:
agent-based modeling
community resources
simulation modeling
information intervention
clinic-to-community linkages