- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02411409
Impact of the CommunityRx Program on Health, Service Utilization and Costs
May 7, 2024 updated by: University of Chicago
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
113295
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
This group of patients receives the 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in cost per beneficiary per year
Time Frame: Annual, up to 6 years
|
Cost per beneficiary per year
|
Annual, up to 6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Every 3 months, up to 72 months
|
|
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 %.
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Every 3 months, up to 72 months
|
|
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
|
Every 3 months, up to 72 months
|
|
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)
|
Every 3 months, up to 72 months
|
|
Change in inpatient admission rate
Time Frame: Every 3 months, up to 72 months
|
Average number of in patient admissions per person
|
Every 3 months, up to 72 months
|
|
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
|
Every 3 months, up to 60 months
|
|
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
|
Every 6 months, up to 60 months
|
|
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
|
Every 3 months, up to 60 months
|
|
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
|
Every 3 months, up to 60 months
|
|
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
|
Every 3 months, up to 60 months
|
|
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
|
Every 3 months, up to 60 months
|
|
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
|
Every 3 months, up to 60 months
|
|
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
|
Every 3 months, up to 60 months
|
|
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
|
Every 3 months, up to 60 months
|
|
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
|
Every 6 months, up to 60 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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Every 3 months, up to 60 months
|
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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
|
Every 3 months, up to 60 months
|
|
Change in number of places mapped (community organizations, identified in the geographic region)
Time Frame: Every year, up to 6 years
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Number of places, or community organizations, identified in the geographic region
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Every year, up to 6 years
|
|
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
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Number of CommunityRx reports created and given to community organizations
|
Every 3 months, up to 60 months
|
|
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
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Every 3 months, up to 60 months
|
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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
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Every 3 months, up to 60 months
|
|
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
|
Every 3 months, up to 60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stacy Lindau, MD, MAPP, University of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2013
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
July 25, 2014
First Submitted That Met QC Criteria
April 7, 2015
First Posted (Estimated)
April 8, 2015
Study Record Updates
Last Update Posted (Actual)
May 9, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- IRB13-0771
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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