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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113295

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 %.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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)
Every 3 months, up to 60 months
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
Number of places, or community organizations, identified in the geographic region
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
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
Every 3 months, up to 60 months
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Connecting Patients to Self-care Resources

Clinical Trials on HealtheRx

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings