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Impact of the CommunityRx Program on Health, Service Utilization and Costs

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT02411409
First received: July 25, 2014
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
The CommunityRx system generates patient-centered e-prescriptions for community services (HealtheRx) via an interface between the electronic health records (EHR) and a comprehensive community resource database. Based on a patient's diagnoses, a HealtheRx will be printed automatically at the end of the ambulatory care visit and will provide patients with a customized map and/or list of places in their community that provide health and social services as well as contact information for a local community health worker who can provide limited case management support. The CommunityRx program aims to promote: 1) better healthcare, 2) better health, and 3) lower cost. The purpose of this research is to systematically evaluate the impact of CommunityRx on health outcomes as well as health care service utilization and total cost of care for Medicaid, Medicare and other beneficiaries. The investigators hypothesize that beneficiaries who participate in the CommunityRx intervention will experience better healthcare, better health and lower total cost of care.

Condition Intervention
Connecting Patients to Self-care Resources
Behavioral: HealtheRx

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of the CommunityRx Program on Health, Service Utilization and Costs

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Change in cost per beneficiary per year [ Time Frame: Annual, up to 6 years ]
    Cost per beneficiary per year


Secondary Outcome Measures:
  • Change in emergency department visit rate [ Time Frame: Every 3 months, up to 72 months ]
    Hospital emergency department visit rate, overall and for patients diagnosed with a) diabetes, b) hypertension, and c) asthma

  • Change in HbA1c control [ Time Frame: Every 3 months, up to 72 months ]
    Percentage of patients 18-75 years of age with diabetes (type 1 or type 2) who had hemoglobin A1c > 9.0 %.

  • Change in controlling high blood pressure [ Time Frame: Every 3 months, up to 72 months ]
    % of patients >=18 years old with hypertension diagnosis and a most recent BP measure <140/90mg

  • Change in body mass index [ Time Frame: Every 3 months, up to 72 months ]
    Percentage of patients overweight or obese (BMI >=25.0 and <30, BMI >=30)

  • Change in inpatient admission rate [ Time Frame: Every 3 months, up to 72 months ]
    Average number of in patient admissions per person

  • Change in participant satisfaction (percentage of participants reporting they are satisfied with the HealtheRx) [ Time Frame: Every 3 months, up to 60 months ]
    Program participant satisfaction survey, percentage of participants reporting they are satisfied with the HealtheRx

  • Change in provider satisfaction ( percent of providers reporting they are satisfied with the HealtheRx system) [ Time Frame: Every 6 months, up to 60 months ]
    Provider satisfaction survey, percent of providers reporting they are satisfied with the HealtheRx system

  • Change in rate of participant use of community-based service providers listed on HealtheRx [ Time Frame: Every 3 months, up to 60 months ]
    Program participant survey, percent of participants who report using at least 1 service listed on their HealtheRx

  • Change in HealtheRx reach (proportion of the population in the geography who receive at least 1 HealtheRx) [ Time Frame: Every 3 months, up to 60 months ]
    The proportion of the population in the geography who receive at least 1 HealtheRx

  • Change in HealtheRx delivery (providers communicate to patients about the HealtheRx) [ Time Frame: Every 3 months, up to 60 months ]
    providers communicate to patients about the HealtheRx

  • Change in HealtheRx usefulness (participant survey, the percent of program participants who report that their HealtheRx is useful) [ Time Frame: Every 3 months, up to 60 months ]
    Program participant survey, the percent of program participants who report that their HealtheRx is useful

  • Change in HealtheRx Understandability (participant survey, the percent of program participants who report that their HealtheRx is easy to understand) [ Time Frame: Every 3 months, up to 60 months ]
    Program participant survey, the percent of program participants who report that their HealtheRx is easy to understand

  • Change in information sharing (participant survey, the percent of program participants who report that they shared information about the HealtheRx with someone else) [ Time Frame: Every 3 months, up to 60 months ]
    Program participant survey, the percent of program participants who report that they shared information about the HealtheRx with someone else

  • Change in knowledge about resources (participant survey, the percent of program participants who report that they did not know about some of the places listed on their HealtheRx) [ Time Frame: Every 3 months, up to 60 months ]
    Program participant survey, the percent of program participants who report that they did not know about some of the places listed on their HealtheRx

  • Change in provider confidence in serving social needs (Provider satisfaction survey,) [ Time Frame: Every 6 months, up to 60 months ]
    Provider satisfaction survey, the proportion of providers reporting they are confident in their ability to serve their patients social needs


Other Outcome Measures:
  • Change in technical problems with the CommunityRx system (e.g., number of times system does not work properly) [ Time Frame: Every 3 months, up to 60 months ]
    The number of technical problems experienced with the CommunityRx system (e.g., number of times system does not work properly)

  • Change in % of eligible patients receiving a HealtheRx [ Time Frame: Every 3 months, up to 60 months ]
    CommunityRx database and electronic medical records, the proportion of eligible patients who receive a HealtheRx

  • Change in number of places mapped (community organizations, identified in the geographic region) [ Time Frame: Every year, up to 6 years ]
    Number of places, or community organizations, identified in the geographic region

  • Change in number of CommunityRx reports delivered (Number of CommunityRx reports created and given to community organizations) [ Time Frame: Every 3 months, up to 60 months ]
    Number of CommunityRx reports created and given to community organizations

  • Change in number of times a community health information specialist is contacted (CHIS call tracker) [ Time Frame: Every 3 months, up to 60 months ]
    CHIS call tracker, number of times a program participant contacted a CHIS

  • Change in referrals by service type (number of referrals, or number of times a service was listed on a HealtheRx) [ Time Frame: Every 3 months, up to 60 months ]
    CommunityRx database, number of referrals, or number of times a service was listed on a HealtheRx

  • Change in services identified (number of services identified as available at community organizations0 [ Time Frame: Every 3 months, up to 60 months ]
    Service level survey, count of number of services identified as available at community organizations


Estimated Enrollment: 200000
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
This group of patients receives the HealtheRx.
Behavioral: HealtheRx
The HealtheRx is a prescription for community self-care resources. It includes a printed list of self-care resources provided to the patient at an ambulatory visit and tailored based on data from the electronic medical record.
No Intervention: Control group
This group of patients does not receive the HealtheRx

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Intervention group eligibility: Patients receiving ambulatory care at a clinical site connected to CommunityRx who live in the CommunityRx geography. Control group eligibility: Patients receiving care at a clinical site connected to CommunityRx who live outside the CommunityRx geography.

Exclusion Criteria:

  • Patients receiving care at a clinical site not connected to CommunityRx.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02411409

Contacts
Contact: Jennifer Makelarski, PhD, MPH 773.834.9877 jmakelarski@babies.bsd.uchicago.edu
Contact: Veronica Escamilla, PhD 773.834.8534 vescamilla@bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jennifer Makelarski, PhD, MPH    773-834-9877    jmakelarski@babies.bsd.uchicago.edu   
Contact: Jennifer Makelarski         
Principal Investigator: Stacy Lindau, MD, MAPP         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Stacy Lindau, MD, MAPP University of Chicago
  More Information

Additional Information:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02411409     History of Changes
Other Study ID Numbers: 1C1CMS330997
Study First Received: July 25, 2014
Last Updated: September 15, 2016

Keywords provided by University of Chicago:
Health Information Technology (HIT)
self-care

ClinicalTrials.gov processed this record on May 25, 2017